Label: CLINIMIX- leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection

  • NDC Code(s): 0338-0180-01, 0338-0180-06, 0338-0184-01, 0338-0184-04, view more
    0338-0188-01, 0338-0188-06, 0338-0194-01, 0338-0194-04, 0338-0198-01, 0338-0198-06, 0338-1089-04, 0338-1091-04, 0338-1099-04, 0338-1101-04, 0338-1133-03, 0338-1134-03, 0338-1137-03, 0338-1138-03, 0338-7001-01, 0338-7001-06, 0338-7003-01, 0338-7003-04, 0338-7005-01, 0338-7005-06, 0338-7007-01, 0338-7007-04, 0338-7009-01, 0338-7009-06, 0338-7011-01, 0338-7011-04, 0338-7013-01, 0338-7013-06, 0338-7015-01, 0338-7015-04
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 13, 2021

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CLINIMIX safely and effectively. See full prescribing information for CLINIMIX.

    CLINIMIX (amino acids in dextrose) injection, for intravenous use
    Initial U.S. Approval: 1997

    RECENT MAJOR CHANGES

     
    Dosage and Administration, Instructions for Use (2.3, 2.7)             04/2021
    Warnings and Precautions (5.5)                                                        04/2021
    Dosage and Administration (2.1, 2.3, 2.4, 2.6, 2.8)                          09/2020

    INDICATIONS AND USAGE

    CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. (1)

    DOSAGE AND ADMINISTRATION

    See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with kidney disease. (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8)

    DOSAGE FORMS AND STRENGTHS

    CLINIMIX injection is available in multiple strengths. See full prescribing information for detailed description of each formulation. (3, 11)

    CONTRAINDICATIONS

    •
    Known hypersensitivity to one or more amino acids or dextrose. (4)
    •
    Inborn errors of amino acid metabolism. (4)
    •
    Patients with pulmonary edema or acidosis due to low cardiac output. (4)

    WARNINGS AND PRECAUTIONS

    •
    Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. (5.1)
    •
    Hypersensitivity Reactions: monitor for signs and symptoms and discontinue infusion if reactions occur. (5.2)
    •
    Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State: monitor for signs and symptoms; monitor laboratory parameters. (5.3, 5.4, 5.5)
    •
    Vein Damage and Thrombosis: solutions with osmolarity of ≥ 900 mOsm/L must be infused through a central catheter. (2.2, 5.6)
    •
    Hepatobiliary Disorders: monitor liver function parameters and ammonia levels. (5.7)
    •
    Aluminum Toxicity: increased risk in patients with impaired kidney function, including preterm infants. (5.8, 8.4)
    •
    Parenteral Nutrition Associated Liver Disease: increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. (5.9, 8.4)
    •
    Electrolyte Imbalance and Fluid Overload: patients with cardiac insufficiency or kidney disease may require adjustment of fluid, protein and electrolyte content. (5.10, 8.4)

    ADVERSE REACTIONS

    Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    USE IN SPECIFIC POPULATIONS

    Pediatric Use: increased risk of hypoglycemia/hyperglycemia: monitor serum glucose concentrations. (8.4)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 4/2021

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Preparation Prior to Administration

    •
    CLINIMIX is available in a three port container configuration and a two port container configuration.
    o
    Three Port Container: the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container.
    o
    Two Port Container: the ports consist of one medication port and one outlet port. Additives, including lipids, can be introduced to the container through the medication port on the two port container.
    •
    Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.
    •
    Inspect the container prior to activation. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following:
    o
    If the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired.
    o
    Check to ensure seal between chambers is intact, solutions are contained in separate chambers, and the content of the individual chambers is clear, colorless or slightly yellow. Discard if the seal is broken or if the solution is bright yellow or yellowish brown.
    o
    Check for minute leaks by separately squeezing each chamber. If external leaks or leakage between the chambers are found, discard solution as sterility or stability may be impaired.
    •
    Lipids and/or additives can be introduced to the container after opening seal between chambers. Because additives may be incompatible, evaluate all additions to the plastic container for compatibility. Activate chambers of container prior to introduction of additives. Mix thoroughly when additives have been introduced. Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.
    •
    Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1)].
    •
    Inspect the container to ensure precipitates have not formed during the mixing or addition of additives. A slight yellow color does not alter the quality and efficacy of this product. If lipid has been added, ensure the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion. Discard the admixture if any of the above are observed.

    2.2 Important Administration Instructions

    •
    Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
    •
    Use a dedicated line without any connections to avoid air embolism.
    •
    CLINIMIX is for intravenous infusion only into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions (5.6)].
    o
    For central vein infusion only: CLINIMIX 4.25/10, 5/15, 5/20, 8/10, 8/14
    o
    For central or peripheral vein infusion: CLINIMIX 4.25/5, 6/5
    •
    The solution should be inspected for precipitates before admixing, after admixing, and again before administration.
    •
    Use a 0.22 micron filter for administration of CLINIMIX. If a lipid is also administered, use a 1.2 micron filter.
    •
    If lipid emulsion is added, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.

    2.3 Instructions for Use

    1.
    Open by tearing protective overwrap at slit and remove solution container. The two port container includes an oxygen-absorbing sachet. Discard the oxygen-absorbing sachet after removal from the overwrap.
    2.
    To proceed with activation, the container should be at room temperature. Lay the room temperature container onto a flat surface. Grasp the container firmly on each side of the top of the container (Figure 1).
    3.
    Starting from the top, using some pressure, slowly roll the container to open seal between chambers as shown in Figure 2. Do not pull or rip the seal apart. The seal must be completely opened towards the port side of the container. The upper section of the seal towards the hanger side can remain unbroken.
    4.
    Mix the contents thoroughly by inverting the container upside down to ensure a homogenous admixture (Figure 3).
    5.
    Once the container is mixed, check for leaks.
    6.
    Make additions (if prescribed).
     
    Because additives may be incompatible, evaluate all additions to the container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. Questions about compatibility may be directed to Baxter. If it is deemed advisable to introduce additives, use aseptic technique. For information on adding lipid emulsions see Dosage and Administration (2.4).
    a.
    Prepare medication port.
    b.
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    c.
    Mix solution and medication thoroughly (Figure 3). For high density medication (high specific gravity), such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
    7.
    Inspect final solution for discoloration and particulate matter. Check for leaks.
    8.
    Spike and hang container.
    a.
    Suspend container from eyelet support.
    b.
    Twist off protector from outlet port at bottom of container (Figure 4).
    c.
    Attach administration set. Refer to complete directions accompanying set.

    For single dose only. Discard unused portion.

    Figures 1-4 (Three Port Container):

    Figure 1-4

    Figures 1-4 (Two Port Container):

    Clinimix Figures 1-4 2 port Container

    Instructions on Storage

    Storage After Removal of Overwrap:

    Once removed from the protective overwrap, mixed (peel seal activated) or unmixed (peel seal intact) CLINIMIX solutions may be stored under refrigeration for up to 9 days.

    Storage Once any Additive is Added:

    Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any remaining mixture must be discarded.

    Protect the activated parenteral nutrition solution from light.

    2.4 Preparation and Addition of Lipid Emulsion

    Three Port Container

    1.
    Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3.
    2.
    Prepare lipid emulsion transfer set following instructions provided.
    3.
    Attach transfer set to lipid emulsion container using aseptic technique.
    4.
    Twist off protector on the additive port of the container.
    5.
    Attach the transfer set to the exposed additive port.
    6.
    Open clamp on transfer set.
    7.
    After completing transfer, use appropriate plastic clamp or metal ferrule to seal off additive port tube.
    8.
    Remove transfer set.
    9.
    Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks.

    Two Port Container

    1.
    Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3.
    2.
    Prepare lipid emulsion transfer set following instructions provided.
    3.
    Attach transfer set to lipid emulsion container using aseptic technique.
    4.
    Prepare medication port.
    5.
    Using a 19 to 22 gauge needle, puncture resealable medication port.
    6.
    Open clamp on transfer set and transfer lipid emulsion.
    7.
    Remove needle.
    8.
    Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks.

    Storage Once Lipids are Added:

    Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any mixture remaining must be discarded.

    2.5 Dosing Considerations

    •
    The dosage of CLINIMIX should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids and dextrose), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Prior to initiating CLINIMIX the following patient information should be reviewed: all concomitant medications, gastrointestinal function and laboratory data such as electrolytes (including magnesium, calcium, and phosphorus), glucose, urea/creatinine, liver panel, complete blood count and triglyceride level (if adding lipid emulsion). Refer to the complete prescribing information of lipid emulsion for dosing information.
    •
    CLINIMIX formulations have varying concentrations of protein and carbohydrate; thus infusion rates to achieve requirements will vary. Protein, caloric, fluid and electrolyte requirements all need to be taken into consideration when determining individual patient dosage needs.
    •
    The dosage selection is based only on the recommended protein requirements. The maximum dextrose infusion rates and calorie and fluid requirements must also be considered when determining the clinically appropriate infusion rate for patients.
    •
    CLINIMIX meets the total nutritional requirements for protein and dextrose in stable patients, and can be individualized to meet specific needs with the addition of nutrients.
    •
    Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with non-carbohydrate or carbohydrate-containing electrolyte solutions. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
    •
    Prior to administration of CLINIMIX correct severe fluid, electrolyte and acid-base disorders.
    •
    Monitor levels of serum potassium during therapy. It may be necessary to add potassium to the CLINIMIX admixture.
    •
    Lipid emulsion administration should be considered with prolonged use (more than 5 days) of CLINIMIX in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free parenteral nutrition. See prescribing information of lipid emulsion.
    •
    The flow rate should be increased gradually. The flow rate must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion.

    2.6 Recommended Dosage in Adults

    The recommended daily nutritional requirements for protein and dextrose compared to the amount of nutrition provided by CLINIMIX are shown in Table 1.

    As indicated on an individual basis, maintenance vitamins, electrolytes, trace elements and other components (including lipids) should be administered as required to prevent deficiencies and complications from developing.

    The maximum infusion rates in adult patients are show in Table 2.

    In addition to meeting protein needs, the administration rate should be governed, especially during the first few day of therapy, by the patient’s tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

    Table 1: Nutritional Comparison –Adult Patients
    *
    Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

    Recommended CLINIMIX Adult Dosage

    CLINIMIX
    4.25/5

    CLINIMIX
    4.25/10

    CLINIMIX
    5/15

    CLINIMIX
    5/20

    CLINIMIX
    6/5

    CLINIMIX
    8/10

    CLINIMIX
    8/14

    Fluid (mL/kg/day)

    19 to 40

    19 to 40

    16 to 40

    16 to 40

    13 to 33

    10 to 25

    10 to 25

    Protein*(g/kg/day)
    (Nitrogen g/kg/day)

    0.8 to 1.7
    (0.13 to 0.27)

    0.8 to 1.7
    (0.13 to 0.27)

    0.8 to 2
    (0.13 to 0.32)

    0.8 to 2
    (0.13 to 0.32)

    0.8 to 2
    (0.13 to 0.32)

    0.8 to 2
    (0.13 to 0.32)

    0.8 to 2
    (0.13 to 0.32)

    Dextrose (g/kg/day)

    0.95 to 2

    1.9 to 4

    2.4 to 6

    3.2 to 8

    0.65 to 1.65

    1 to 2.5

    1.4 to 3.5

    Table 2: Maximum Infusion Rate in Adult Patients
    *
    Rate limiting factor

    Maximum Infusion Rates in Adults Patients

    CLINIMIX
    4.25/5

    CLINIMIX
    4.25/10

    CLINIMIX
    5/15

    CLINIMIX
    5/20

    CLINIMIX
    6/5

    CLINIMIX
    8/10

    CLINIMIX
    8/14

    Maximum Infusion Rate (mL/kg/hour)

    2.4

    2.4

    1.67

    1.25

    1.67

    1.3

    1.3

    Corresponding infusion rate

    Amino Acid (g/kg/hour)

    0.1*

    0.1*

    0.08

    0.06

    0.1*

    0.1*

    0.1*

    Dextrose
    (g/kg/hour)

    0.12

    0.24

    0.25*

    0.25*

    0.08

    0.13

    0.18

    2.7 Dosage Modifications in Patients with Kidney Disease

    Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of CLINIMIX administered as required [see Warnings and Precautions (5.10)].

    Chronic kidney disease patients with less than nephrotic range proteinuria require 0.8 g of protein/kg/day. Chronic kidney disease patients with nephrotic range proteinuria require 0.8g of protein/kg/day plus 1g of protein for each gram of proteinuria. Patients needing dialysis should receive from 1.2 of protein/kg/day up to a maximum of 2.5 g of protein/kg/day depending on the nutritional status and the dialysis modality. Serum electrolyte levels should be closely monitored. The CLINIMIX dosage can be adjusted based on the severity of kidney disease, supplementing protein as indicated. If required, additional amino acids may be added to the CLINIMIX container or infused separately. Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Baxter.

    2.8 Recommended Dosage in Pediatric Patients

    The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia [see Use in Specific Populations (8.4)]. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

    In pediatric patients, CLINIMIX is dosed on the basis of protein provided as amino acids. The recommended dosage, by age group is provided in Tables 3 - 6. Infusion rates are based on protein and do not take carbohydrates, fluid or electrolytes into consideration.

    This product does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants. If possible, these amino acids should be added to this product if used in this pediatric population.

    Table 3: Preterm and Term Infants Less than 1 Month of Age
    *
    Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

    Recommended CLINIMIX Dosage in Preterm and Term Infants Less than 1 Month of Age

    CLINIMIX
    4.25/5

    CLINIMIX
    4.25/10

    CLINIMIX
    5/15

    CLINIMIX 5/20

    CLINIMIX
    6/5

    CLINIMIX
    8/10

    CLINIMIX
    8/14

    Infusion Rate Range (mL/kg/hr)

    2.9 to 3.9

    2.9 to 3.9

    2.5 to 3.3

    2.5 to 3.3

    2.1 to 2.8

    1.6 to 2.1

    1.6 to 2.1

    Fluid (mL/kg/day)

    70 to 94

    70 to 94

    60 to 79

    60 to 79

    50 to 67

    38.4 to 50

    38.4 to 50

    Protein*
    (g/kg/day)
    (Nitrogen g/kg/day)

    3 to 4
    (0.48 to 0.64)

    3 to 4
    (0.48 to 0.64)

    3 to 4
    (0.48 to 0.64)

    3 to 4
    (0.48 to 0.64)

    3 to 4
    (0.48 to 0.64)

    3 to 4
    (0.48 to 0.64)

    3 to 4
    (0.48 to 0.64)

    Dextrose (g/kg/day)

    3.5 to 4.7

    7 to 9.4

    9 to 11.9

    12 to 15.8

    2.5 to 3.4

    3.8 to 5

    5.4 to 7

    Table 4: Pediatric Patients 1 Month to Less than 1 Year of Age
    *
    Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

    Recommended CLINIMIX Dosage in Pediatric Patients 1 Month to Less than 1 Year of Age

    CLINIMIX
    4.25/5

    CLINIMIX
    4.25/10

    CLINIMIX
    5/15

    CLINIMIX
    5/20

    CLINIMIX
    6/5

    CLINIMIX
    8/10

    CLINIMIX
    8/14

    Infusion Rate Range (mL/kg/hr)

    2 to 2.9

    2 to 2.9

    1.7 to 2.5

    1.7 to 2.5

    1.4 to 2.1

    1 to 1.6

    1 to 1.6

    Fluid (mL/kg/day)

    48 to 70

    48 to 70

    41 to 60

    41 to 60

    33.6 to 50

    24 to 38.4

    24 to 38.4

    Protein*
    (g/kg/day)
    (Nitrogen g/kg/day)

    2 to 3
    (0.32 to 0.48)

    2 to 3
    (0.32 to 0.48)

    2 to 3
    (0.32 to 0.48)

    2 to 3
    (0.32 to 0.48)

    2 to 3
    (0.32 to 0.48)

    2 to 3
    (0.32 to 0.48)

    2 to 3
    (0.32 to 0.48)

    Dextrose (g/kg/day)

    2.4 to 3.5

    4.8 to 7

    6.1 to 9

    8.2 to 12

    1.7 to 2.5

    2.4 to 3.8

    3.4 to 5.4

    Table 5: Pediatric Patients 1 Year to Less than 11 Years of Age
    *
    Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

    Recommended CLINIMIX Dosage in Pediatric Patients 1 Year to Less than 11 Years of Age

    CLINIMIX
    4.25/5

    CLINIMIX
    4.25/10

    CLINIMIX
    5/15

    CLINIMIX
    5/20

    CLINIMIX
    6/5

    CLINIMIX
    8/10

    CLINIMIX
    8/14

    Infusion Rate Range (mL/kg/hr)

    1 to 2

    1 to 2

    0.8 to 1.7

    0.8 to 1.7

    0.7 to 1.4

    0.5 to 1

    0.5 to 1

    Fluid (mL/kg/day)

    24 to 48

    24 to 48

    19 to 41

    19 to 41

    16.8 to 33.6

    12 to 24

    12 to 24

    Protein*(g/kg/day)
    (Nitrogen g/kg/day)

    1 to 2
    (0.16 to 0.32)

    1 to 2
    (0.16 to 0.32)

    1 to 2
    (0.16 to 0.32)

    1 to 2
    (0.16 to 0.32)

    1 to 2
    (0.16 to 0.32)

    1 to 2
    (0.16 to 0.32)

    1 to 2
    (0.16 to 0.32)

    Dextrose (g/kg/day)

    1.2 to 2.4

    2.4 to 4.8

    2.9 to 6.1

    3.8 to 8.2

    0.8 to 1.7

    1.2 to 2.4

    1.7 to 3.4

    Table 6: Pediatric Patients 11 Years to 17 Years of Age
    *
    Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

    Recommended CLINIMIX Dosage in Pediatric Patients 11 Years to 17 Years of Age

    CLINIMIX
    4.25/5

    CLINIMIX
    4.25/10

    CLINIMIX
    5/15

    CLINIMIX
    5/20

    CLINIMIX
    6/5

    CLINIMIX
    8/10

    CLINIMIX
    8/14

    Infusion Rate Range (mL/kg/hr)

    0.8 to 1.5

    0.8 to 1.5

    0.7 to 1.3

    0.7 to 1.3

    0.6 to 1

    0.4 to 0.8

    0.4 to 0.8

    Fluid (mL/kg/day)

    19 to 36

    19 to 36

    17 to 31

    17 to 31

    14.4 to 24

    9.6 to 19.2

    9.6 to 19.2

    Protein*(g/kg/day)
    (Nitrogen g/kg/day)

    0.8 to 1.5
    (0.13 to 0.24)

    0.8 to 1.5
    (0.13 to 0.24)

    0.8 to 1.5
    (0.13 to 0.24)

    0.8 to 1.5
    (0.13 to 0.24)

    0.8 to 1.5
    (0.13 to 0.24)

    0.8 to 1.5
    (0.13 to 0.24)

    0.8 to 1.5
    (0.13 to 0.24)

    Dextrose (g/kg/day)

    1 to 1.8

    1.9 to 3.6

    2.5 to 4.7

    3.4 to 6.2

    0.7 to 1.2

    1 to 1.9

    1.4 to.2.7

    2.9 Discontinuation of CLINIMIX

    To reduce the risk of hypoglycemia after discontinuation, a gradual decrease in flow rate in the last hour of infusion should be considered.

  • 3 DOSAGE FORMS AND STRENGTHS

    CLINIMIX injection is available in 1000 mL and 2000 mL dual chamber containers. The individual chambers contain essential and nonessential amino acids and dextrose. Table 7 describes the individual components of CLINIMIX.

    Table 7: INGREDIENTS PER 100mL OF CLINIMIX
    *
    Balanced by ions from amino acids.
    †
    Derived from glacial acetic acid (for pH adjustment).
    ‡
    Contributed by lysine hydrochloride and hydrochloric acid (for pH adjustment).
    §
    pH of sulfite-free amino acid injection in the outlet port chamber may be adjusted with glacial acetic acid and pH of dextrose injection port chamber may be adjusted with hydrochloric acid.

    Strength of CLINIMIX

    CLINIMIX
    4.25/5 sulfite‑free
    (4.25% Amino Acid in 5% Dextrose) Injection

    CLINIMIX4.25/10 sulfite‑free
    (4.25% Amino Acid in 10% Dextrose) Injection

    CLINIMIX
    5/15 sulfite‑free
    (5% Amino Acid in 15% Dextrose) Injection

    CLINIMIX
    5/20 sulfite‑free
    (5% Amino Acid in 20% Dextrose) Injection

    CLINIMIX
    6/5 sulfite‑free
    (6% Amino Acid in 5% Dextrose) Injection

    CLINIMIX
    8/10 sulfite‑free
    (8% Amino Acid in 10% Dextrose) Injection

    CLINIMIX
    8/14 sulfite‑free
    (8% Amino Acid in 14% Dextrose) Injection

    Dextrose Hydrous, USP (g/100 mL)

    5

    10

    15

    20

    5

    10

    14

    Amino Acids (g/100 mL)

    4.25

    4.25

    5

    5

    6

    8

    8

    Total Nitrogen (mg/100 mL)

    702

    702

    826

    826

    990

    1320

    1320

     
    Essential
    Amino Acids
    (mg/100 mL)

    Leucine

    311

    311

    365

    365

    438

    584

    584

    Isoleucine

    255

    255

    300

    300

    360

    480

    480

    Valine

    247

    247

    290

    290

    348

    464

    464

    Lysine (added as the hydrochloride salt)

    247

    247

    290

    290

    348

    464

    464

    Phenylalanine

    238

    238

    280

    280

    336

    448

    448

    Histidine

    204

    204

    240

    240

    288

    384

    384

    Threonine

    179

    179

    210

    210

    252

    336

    336

    Methionine

    170

    170

    200

    200

    240

    320

    320

    Tryptophan

    77

    77

    90

    90

    108

    144

    144

     
    Nonessential
    Amino Acids
    (mg/100 mL)

    Alanine

    880

    880

    1035

    1035

    1242

    1656

    1656

    Arginine

    489

    489

    575

    575

    690

    920

    920

    Glycine

    438

    438

    515

    515

    618

    824

    824

    Proline

    289

    289

    340

    340

    408

    544

    544

    Serine

    213

    213

    250

    250

    300

    400

    400

    Tyrosine

    17

    17

    20

    20

    24

    32

    32

     
    Anion
    Profile
    (mEq/L)*

    Acetate†

    37

    37

    42

    42

    53

    71

    71

    Chloride‡

    17

    17

    20

    20

    24

    32

    32

    pH§(Range)

    6.0
    (4.5 to 7.0)

    6.0
    (4.5 to 7.0)

    6.0
    (4.5 to 7.0)

    6.0
    (4.5 to 7.0)

    6.0
    (4.5 to 7.0)

    6.0
    (4.5 to 7.0)

    6.0
    (4.5 to 7.0)

    Osmolarity (mOsmol/L) (calc)

    675

    930

    1255

    1505

    850

    1308

    1520

    Caloric
    Content
    (kcal/L)

    From Dextrose

    170

    340

    510

    680

    170

    343

    477

    From Amino Acids

    170

    170

    200

    200

    240

    320

    320

    TOTAL
    (Dextrose and Amino Acids)

    340

    510

    710

    880

    410

    663

    797

  • 4 CONTRAINDICATIONS

    The use of CLINIMIX is contraindicated in:

    •
    Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.2)].
    •
    Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications.
    •
    Patients with pulmonary edema or acidosis due to low cardiac output.
  • 5 WARNINGS AND PRECAUTIONS

    5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates

    Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. CLINIMIX contains no added phosphorus. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)], the infusion set and catheter should also periodically be checked for precipitates.

    5.2 Hypersensitivity Reactions

    Hypersensitivity/infusion reactions including anaphylaxis have been reported with CLINIMIX. Stop infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills.

    5.3 Risk of Infections

    Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. Infection and sepsis may also occur as a result of the use of intravenous catheters to administer parenteral nutrition.

    The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).

    To decrease the risk of infection, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula.

    Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.

    5.4 Refeeding Syndrome

    Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.

    5.5 Hyperglycemia or Hyperosmolar Hyperglycemic State

    When using CLINIMIX in patients with diabetes mellitus, impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Patients with dehydration, resulting in a transient reduction in glomerular filtration rate and pre-renal azotemia, may be a greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering CLINIMIX. Insulin may be administered or adjusted to maintain optimal blood glucose levels during CLINIMIX administration.

    5.6 Vein Damage and Thrombosis

    Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter. CLINIMIX solutions containing more than 5% dextrose have an osmolarity greater than or equal to 900 mOsm/L. CLINIMIX 4.25/10, 5/15, 5/20, 8/10 and 8/14 are indicated for administration into a central vein only, such as the superior vena cava [see Dosage and Administration (2.2)]. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis.

    CLINIMIX 4.25/5 and 6/5 are indicated for peripheral administration, or may be infused into a central vein [see Dosage and Administration (2.2)]. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

    5.7 Hepatobiliary Disorders

    Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive parenteral nutrition, including cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of these disorders is thought to be multifactorial and may differ between patients.

    Increase in blood ammonia levels and hyperammonemia may occur in patients receiving amino acid solutions. In some patients this may indicate hepatic insufficiency or the presence of an inborn error of amino acid metabolism [see Contraindications (4)].

    Monitor liver function parameters and ammonia levels. Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.

    5.8 Aluminum Toxicity

    CLINIMIX contains no more than 25 mcg/L of aluminum. The aluminum contained in CLINIMIX may reach toxic levels with prolonged administration in patients with impaired kidney function. Preterm infants are at a greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

    5.9 Risk of Parenteral Nutrition Associated Liver Disease

    Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. If CLINIMIX treated patients develop liver test abnormalities consider discontinuation or dosage reduction.

    5.10 Electrolyte Imbalance and Fluid Overload

    Patients with abnormal renal function due to pre-renal azotemia, renal obstruction, or intrinsic kidney disease may be at increased risk of electrolyte and fluid volume imbalance. Patients with cardiac insufficiency due to left ventricular systolic dysfunction are susceptible to excess fluid accumulation. Use CLINIMIX with caution in patients with cardiac insufficiency or kidney disease. CLINIMIX dosage may require adjustment with specific attention to fluid, protein, and electrolyte content in these patients.

    Monitor renal function parameters. Patients developing signs of kidney disease should be assessed early by a clinician knowledgeable in kidney disease in order to determine the appropriate CLINIMIX dosage and other treatment options.

    5.11 Monitoring/Laboratory Tests

    Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment.

    Patients receiving CLINIMIX should be monitored frequently and their electrolyte requirements individualized.

  • 6 ADVERSE REACTIONS

    The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

    •
    Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1)]
    •
    Hypersensitivity reactions [see Warnings and Precautions (5.2)]
    •
    Risk of Infections [see Warnings and Precautions (5.3)]
    •
    Refeeding syndrome [see Warnings and Precautions (5.4)]
    •
    Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5)]
    •
    Vein damage and thrombosis [see Warnings and Precautions (5.6)]
    •
    Hepatobiliary disorders [see Warnings and Precautions (5.7)]
    •
    Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9)]
    •
    Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10)]

    The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    •
    Diuresis
    •
    Extravasation
    •
    Glycosuria
    •
    Hyperglycemia
    •
    Hyperosmolar coma
  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman.

    The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

    Clinical Considerations

    Disease-Associated Maternal and/or Embryo-Fetal Risk

    Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.

    8.2 Lactation

    Risk Summary

    It is not known whether CLINIMIX is present in human milk. There are no data on the effects of CLINIMIX on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINIMIX and any potential adverse effects on the breastfed child from CLINIMIX or from the underlying maternal condition.

    8.4 Pediatric Use

    Safety and effectiveness of CLINIMIX in pediatric patients have not been established by adequate and well-controlled studies. Use of dextrose, amino acid infusions and electrolytes in pediatric patients is based on clinical practice [see Dosage and Administration (2.8)].

    Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

    Because of immature renal function, preterm infants receiving prolonged treatment with CLINIMIX may be at risk of aluminum toxicity [see Warnings and Precautions (5.8)].

    Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9)].

    Hyperammonemia is of special significance in infants (birth to two years). This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions (5.7)].

    8.5 Geriatric Use

    Clinical studies of CLINIMIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

  • 10 OVERDOSAGE

    An increased infusion rate of CLINIMIX cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.5, 5.10)].

    Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal.

    Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems.

    For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

  • 11 DESCRIPTION

    CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container.

    The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8.

    Table 8: Formulas for Amino Acids

    Essential Amino Acids

    Leucine

    (CH3)2 CHCH2CH (NH2) COOH

    Isoleucine

    CH3CH2CH (CH3) CH (NH2) COOH

    Valine

    (CH3)2 CHCH (NH2) COOH

    Lysine (added as the hydrochloride salt)

    H2N (CH2)4 CH (NH2) COOH

    Phenylalanine

    (C6H5) CH2 CH (NH2) COOH

    Histidine

    (C3H3N2) CH2CH (NH2) COOH

    Threonine

    CH3CH (OH) CH (NH2) COO

    Methionine

    CH3S (CH2)2 CH (NH2) COOH

    Tryptophan

    (C8H6N) CH2 CH (NH2) COOH

    Nonessential Amino Acids

    Alanine

    CH3CH (NH2) COOH

    Arginine

    H2NC (NH) NH (CH2)3 CH (NH2) COOH

    Glycine

    H2NCH2COOH

    Proline

    [(CH2)3 NH CH] COOH

    Serine

    HOCH2CH (NH2) COOH

    Tyrosine

    [C6H4 (OH)] CH2CH (NH2) COOH

    The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 • H2O) and has the following structure:

    Structural Formula Dexrose Hydrous, USP

    Dextrose is derived from corn.

    See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)].

    The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic).

    CLINIMIX contains no more than 25 mcg/L of aluminum.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    CLINIMIX is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) parenterally.

    The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as a source of energy.

    The administered dextrose is oxidized to carbon dioxide and water, yielding energy.

    12.3 Pharmacokinetics

    The disposition of infused amino acids and dextrose, are essentially the same as those absorbed from ordinary food.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    CLINIMIX (amino acids in dextrose) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9).

    Table 9: CLINIMIX Formulations (per 07-19-00-3604 and BE-30-03-648)
     
    After mixing, the product represents
     
    1000 mL Code and NDC Number
     
    2000 mL Code and NDC Number
     
    CLINIMIX 4.25/5 sulfite‑free
    (4.25% Amino Acid in 5% Dextrose) Injection
     
    Code 2B7726
    NDC 0338‑1133‑03
     
    Code 2B7704
    NDC 0338‑1089‑04
     
    CLINIMIX 4.25/10 sulfite‑free
    (4.25% Amino Acid in 10% Dextrose) Injection
     
    Code 2B7727
    NDC 0338‑1134‑03
     
    Code 2B7705
    NDC 0338‑1091‑04
     
    CLINIMIX 5/15 sulfite‑free
    (5% Amino Acid in 15% Dextrose) Injection
     
    Code 2B7730
    NDC 0338‑1137‑03
     
    Code 2B7709
    NDC 0338‑1099‑04
     
    CLINIMIX 5/20 sulfite‑free
    (5% Amino Acid in 20% Dextrose) Injection
     
    Code 2B7731
    NDC 0338‑1138‑03
     
    Code 2B7710
    NDC 0338‑1101‑04
     
    CLINIMIX 6/5 sulfite‑free
    (6% Amino Acid in 5% Dextrose) Injection
     
    Code EADB9913
    NDC 0338‑0198-06
     
    _____
     
    CLINIMIX 8/10 sulfite‑free
    (8% Amino Acid in 10% Dextrose) Injection
     
    Code EADB9933
    NDC 0338‑0188-06
     
    Code EADB9935
    NDC 0338‑0194-04
     
    CLINIMIX 8/14 sulfite‑free
    (8% Amino Acid in 14% Dextrose) Injection
     
    Code EADB9953
    NDC 0338‑0180-06
     
    Code EADB9955
    NDC 0338‑0184-04

    Table 9: CLINIMIX Formulations (per BE-30-04-047)

     
    After mixing, the product represents
     
    1000 mL Code and NDC Number
     
    2000 mL Code and NDC Number
     
    CLINIMIX 4.25/5 sulfite‑free
    (4.25% Amino Acid in 5% Dextrose) Injection
     
    Code 2B7726L
    NDC 0338‑7001-01
     
    Code 2B7704L
    NDC 0338‑7003-01
     
    CLINIMIX 4.25/10 sulfite‑free
    (4.25% Amino Acid in 10% Dextrose) Injection
     
    Code 2B7727L
    NDC 0338‑7005-01
     
    Code 2B7705L
    NDC 0338‑7007-01
     
    CLINIMIX 5/15 sulfite‑free
    (5% Amino Acid in 15% Dextrose) Injection
     
    Code 2B7730L
    NDC 0338‑7009-01
     
    Code 2B7709L
    NDC 0338‑7011-01
     
    CLINIMIX 5/20 sulfite‑free
    (5% Amino Acid in 20% Dextrose) Injection
     
    Code 2B7731L
    NDC 0338‑7013-01
     
    Code 2B7710L
    NDC 0338‑7015-01
     
    CLINIMIX 6/5 sulfite‑free
    (6% Amino Acid in 5% Dextrose) Injection
     
    Code EADB9913
    NDC 0338‑0198-06
     
    _____
     
    CLINIMIX 8/10 sulfite‑free
    (8% Amino Acid in 10% Dextrose) Injection
     
    Code EADB9933
    NDC 0338‑0188-06
     
    Code EADB9935
    NDC 0338‑0194-04
     
    CLINIMIX 8/14 sulfite‑free
    (8% Amino Acid in 14% Dextrose) Injection
     
    Code EADB9953
    NDC 0338‑0180-06
     
    Code EADB9955
    NDC 0338‑0184-04

    Minimize exposure of CLINIMIX to heat and avoid excessive heat.

    Protect from freezing.

    Store CLINIMIX at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F).

    Refrigerated storage is limited to 9 days once the protective overwrap has been opened.

    Do not use if the protective overwrap has been previously opened or damaged.

    For storage of admixed solutions see Dosage and Administration (2.3, 2.4).

  • 17 PATIENT COUNSELING INFORMATION

    Inform patients, caregivers, or home healthcare providers of the following risks of CLINIMIX:

    •
    Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1)]
    •
    Hypersensitivity reactions [see Warnings and Precautions (5.2)]
    •
    Risk of Infections [see Warnings and Precautions (5.3)]
    •
    Refeeding syndrome [see Warnings and Precautions (5.4)]
    •
    Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5)]
    •
    Vein damage and thrombosis [see Warnings and Precautions (5.6)]
    •
    Hepatobiliary disorders [see Warnings and Precautions (5.7)]
    •
    Aluminum toxicity [see Warnings and Precautions (5.8)]
    •
    Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9)]
    •
    Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10)]
  • SPL UNCLASSIFIED SECTION

     
    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
     
    Baxter and Clinimix are registered trademarks of Baxter International Inc.
     
    07-19-00-360 [Applies to Baxter Healthcare Corporation, Jayuya – Puerto Rico manufacturing plant]
     
    BE-30-03-648 [Applies to Baxter SA, Lessines – Belgium manufacturing plant for Clinimix 6/5, Clinimix 8/10 and Clinimix 8/14]
     
    BE-30-04-047 [Applies to Baxter SA, Lessines – Belgium manufacturing plant for the other Clinimix formulations]
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    Representative Container Label 0338-1134

    Container Label

    LOT EXP
    2B7727 NDC 0338-1134-03

    CLINIMIX
    4.25/10
    SULFITE-FREE

    (4.25% Amino Acids
    in 10% Dextrose)
    Injection

    500 mL INJECTION PORT CHAMBER
    20% Dextrose Injection USP

    500 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON
    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY
    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 10 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Representative Container Label 0338-1133-03

    Container Label

    LOT EXP

    2B7726 NDC 0338-1133-03

    CLINIMIX

    4.25/5

    SULFITE-FREE

    (4.25% Amino Acids
    in 5% Dextrose)
    Injection

    500 mL INJECTION PORT CHAMBER
    10% Dextrose Injection USP

    500 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 5 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Representative Container Label 0338-1089-04

    Container Label

    LOT EXP

    2B7704 NDC 0338-1089-04

    CLINIMIX 4.25/5
    SULFITE-FREE
    (4.25% Amino Acid
    in 5% Dextrose)
    Injection

    1000 mL INJECTION PORT CHAMBER
    10% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTIONDEXTROSE HYDROUS USP 5 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA
    Representative Container Label 0338-1091-04

    Container Label

    LOT EXP

    2B7705 NDC 0338-1091-04

    CLINIMIX 4.25/10
    SULFITE-FREE
    (4.25% Amino Acid
    in 10% Dextrose)
    Injection

    1000 mL INJECTION PORT CHAMBER
    20% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION

    DEXTROSE HYDROUS USP 10 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Representative Container 0338-1137-03

    Container Label

    LOT EXP

    2B7730 NDC 0338-1137-03

    CLINIMIX
    5/15
    SULFITE-FREE
    (5% Amino Acid
    in 15% Dextrose)
    Injection

    500 mL INJECTION PORT CHAMBER
    30% Dextrose Injection USP

    500 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION

    DEXTROSE HYDROUS USP 15 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Representative Container Label 0338-1099-04

    Container Label

    LOT EXP

    2B7709 NDC 0338-1099-04

    CLINIMIX
    5/15
    SULFITE-FREE
    (5% Amino Acid
    in 15% Dextrose)
    Injection

    1000 mL INJECTION PORT CHAMBER
    30% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION

    DEXTROSE HYDROUS USP 15 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Representative Container Label 0338-1138-03

    Container Label

    LOT EXP

    2B7731 NDC 0338-1138-03

    CLINIMIX
    5/
    SULFITE-FREE
    (5% Amino Acid
    in 20% Dextrose)
    Injection

    500 mL INJECTION PORT CHAMBER
    40% Dextrose Injection USP

    500 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION

    DEXTROSE HYDROUS USP 20 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Representative Container Label 0338-1101-04

    Container Label

    LOT EXP

    2B7710 NDC 0338-1101-04

    CLINIMIX
    5/20
    SULFITE-FREE
    (5% Amino Acid
    in 20% Dextrose)
    Injection

    1000 mL INJECTION PORT CHAMBER
    40% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON

    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY

    AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION

    DEXTROSE HYDROUS USP 20 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    ROOM TEMPERATURE (25°C/77°F)

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    Clinimix Representative Container Label 0338-0198-01

    Container Label

    EADB9913
    NDC 0338-0198-01

    1000 mL

    CLINIMIX
    6/5
    SULFITE-FREE
    (6% Amino Acid
    in 5% Dextrose)
    Injection

    400 mL INJECTION PORT CHAMBER
    12.5% Dextrose Injection USP
    600 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection
    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHTLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
    ON ACTIVATION
    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL
    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
    ONCE OVERWRAP IS OPENED
    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT
    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 5 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 438 mg
    ISOLEUCINE 360 mg
    VALINE 348 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 348 mg
    PHENYLALANINE 336 mg
    HISTIDINE 288 mg
    THREONINE 252 mg
    METHIONINE 240 mg
    TRYPTOPHAN 108 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1242 mg
    ARGININE 690 mg
    GLYCINE 618 mg
    PROLINE 408 mg
    SERINE 300 mg
    TYROSINE 24 mg

    mEq/L
    ACETATE 53
    CHLORIDE 24

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE

    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25ºC/77ºF)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    EXP LOT

    BE-35-04-040

    Clinimix Representative Container Label 0338-0188-01

    Container Label

    EADP9933
    NDC 0338-0188-01

    1000 mL

    CLINIMIX
    8/10
    SULFITE-FREE
    (8% Amino Acid
    in 10% Dextrose)
    Injection

    360 mL INJECTION PORT CHAMBER
    28% Dextrose Injection USP
    640 mL OUTLET PORT CHAMBER
    12.5% Amino Acid Injection
    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHTLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
    ON ACTIVATION
    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL
    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
    ONCE OVERWRAP IS OPENED
    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT
    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 10 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 584 mg
    ISOLEUCINE 480 mg
    VALINE 464 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 464 mg
    PHENYLALANINE 448 mg
    HISTIDINE 384 mg
    THREONINE 336 mg
    METHIONINE 320 mg
    TRYPTOPHAN 144 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1656 mg
    ARGININE 920 mg
    GLYCINE 824 mg
    PROLINE 544 mg
    SERINE 400 mg
    TYROSINE 32 mg

    mEq/L
    ACETATE 71
    CHLORIDE 32

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE

    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25ºC/77ºF)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    EXP LOT

    BE-35-04-041

    Clinimix Representative Container Label 0338-0194-01

    Container Label

    EADB9935
    NDC 0338-0194-01

    2000 mL

    CLINIMIX
    8/10
    SULFITE-FREE
    (8% Amino Acid
    in 10% Dextrose)
    Injection

    720 mL INJECTION PORT CHAMBER
    28% Dextrose Injection USP
    1280 mL OUTLET PORT CHAMBER
    12.5% Amino Acid Injection
    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHTLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION
    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL
    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
    ONCE OVERWRAP IS OPENED
    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND
    EFFICACY OF THIS PRODUCT
    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION
    DEXTROSE HYDROUS USP 10 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 584 mg
    ISOLEUCINE 480 mg
    VALINE 464 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 464 mg
    PHENYLALANINE 448 mg
    HISTIDINE 384 mg
    THREONINE 336 mg
    METHIONINE 320 mg
    TRYPTOPHAN 144 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1656 mg
    ARGININE 920 mg
    GLYCINE 824 mg
    PROLINE 544 mg
    SERINE 400 mg
    TYROSINE 32 mg

    mEq/L
    ACETATE 71
    CHLORIDE 32

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25ºC/77ºF)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    Exp Lot

    BE-35-04-045

    Clinimix Representative Container Label 0338-0180-01

    Container Label

    EADB9953
    NDC 0338-0180-01

    1000 mL

    CLINIMIX
    8/14
    SULFITE-FREE
    (8% Amino Acid
    in 14% Dextrose)
    Injection

    360 mL INJECTION PORT CHAMBER
    39% Dextrose Injection USP
    640 mL OUTLET PORT CHAMBER
    12.5% Amino Acid Injection
    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHTLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
    ON ACTIVATION
    AFTER MIXING THE PRODUCT REPRESENTS 1000 mL
    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
    ONCE OVERWRAP IS OPENED
    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT
    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 14 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 584 mg
    ISOLEUCINE 480 mg
    VALINE 464 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 464 mg
    PHENYLALANINE 448 mg
    HISTIDINE 384 mg
    THREONINE 336 mg
    METHIONINE 320 mg
    TRYPTOPHAN 144 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1656 mg
    ARGININE 920 mg
    GLYCINE 824 mg
    PROLINE 544 mg
    SERINE 400 mg
    TYROSINE 32 mg

    mEq/L
    ACETATE 71
    CHLORIDE 32

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25ºC/77ºF)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    EXP LOT

    BE-35-04-043

    Clinimix Representative Container Label 0338-0184-01

    Container Label

    EADB9955
    NDC 0338-0184-01

    2000 mL

    CLINIMIX
    8/14
    SULFITE-FREE
    (8% Amino Acid
    in 14% Dextrose)
    Injection

    720 mL INJECTION PORT CHAMBER
    39% Dextrose Injection USP
    1280 mL OUTLET PORT CHAMBER
    12.5% Amino Acid Injection
    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHTLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION
    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL
    REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
    ONCE OVERWRAP IS OPENED
    A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND
    EFFICACY OF THIS PRODUCT
    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE
    ADMIXED INJECTION
    DEXTROSE HYDROUS USP 14 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 584 mg
    ISOLEUCINE 480 mg
    VALINE 464 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 464 mg
    PHENYLALANINE 448 mg
    HISTIDINE 384 mg
    THREONINE 336 mg
    METHIONINE 320 mg
    TRYPTOPHAN 144 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1656 mg
    ARGININE 920 mg
    GLYCINE 824 mg
    PROLINE 544 mg
    SERINE 400 mg
    TYROSINE 32 mg

    mEq/L
    ACETATE 71
    CHLORIDE 32

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25ºC/77ºF)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    Exp Lot

    BE-35-04-047

    Clinimix Representative Container Label 0338-7001-01

    Container Label

    2B7726L
    NDC0338-7001-01

    1000 mL

    CLINIMIX
    4.25/10
    SULFITE-FREE
    (4.25% Amino Acids in 5% Dextrose)

    Injection

    500 mL INJECTION PORT CHAMBER
    10% Dextrose Injection USP

    500 mL OUTLET PORT CHAMBER

    8.5% Amino Acid Injection
    Rx Only

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR
    INSTRUCTIONS ON ACTIVATION

    AFTER MIXING THE PRODUCT
    REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT
    ALTER THE QUALITY AND EFFICACY OF
    THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE
    COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
    DEXTROSE HYDROUS USP 5 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    1600

    1000

    800

    600

    400

    200

    BE-35-04-993

    EXP LOT

    Clinimix Representative Container Label 0338-7003-01

    Container Label

    2B7704L
    NDC0338-7003-01

    2000mL

    CLINIMIX
    4.25/5

    SULFITE-FREE

    (4.25% Amino Acids
    in 5% Dextrose)
    Injection

    1000 mL INJECTION PORT CHAMBER
    10% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
    ON ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 5 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    2000

    1600

    1000

    800

    600

    400

    200

    BE-35-04-985

    EXP LOT

    Clinimix Representative Container Label 0338-7005-01

    Container Label

    2B7727L
    NDC0338-7005-01

    1000mL

    CLINIMIX
    4.25/10
    SULFITE-FREE
    (4.25% Amino Acids in 10% Dextrose)

    Injection

    CENTRAL LINE INFUSION ONLY

    500 mL INJECTION PORT CHAMBER
    20% Dextrose Injection USP
    500 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection
    Rx Only

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR
    INSTRUCTIONS ON ACTIVATION

    AFTER MIXING THE PRODUCT
    REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT
    ALTER THE QUALITY AND EFFICACY OF
    THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE
    COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
    DEXTROSE HYDROUS USP 10 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    1600

    1000

    800

    600

    400

    200

    BE-35-04-994

    EXP LOT

    Clinimix Representative Container Label 0338-7007-01

    Container Label

    2B7705L
    NDC0338-7007-01

    2000mL

    CLINIMIX
    4.25/10

    SULFITE-FREE

    (4.25% Amino Acids
    in 10% Dextrose)
    Injection

    CENTRAL LINE INFUSION ONLY

    1000 mL INJECTION PORT CHAMBER
    20% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    8.5% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
    ON ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 10 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 311 mg
    ISOLEUCINE 255 mg
    VALINE 247 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 247 mg
    PHENYLALANINE 238 mg
    HISTIDINE 204 mg
    THREONINE 179 mg
    METHIONINE 170 mg
    TRYPTOPHAN 77 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 880 mg
    ARGININE 489 mg
    GLYCINE 438 mg
    PROLINE 289 mg
    SERINE 213 mg
    TYROSINE 17 mg

    mEq/L
    ACETATE 37
    CHLORIDE 17

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    2000

    1600

    1000

    800

    600

    400

    200

    BE-35-04-996

    EXP LOT

    Clinimix Representative Container Label 0338-7009-01

    Container Label

    2B7730L
    NDC0338-7009-01

    1000mL

    CLINIMIX
    5/15
    SULFITE-FREE
    (5% Amino Acids

    in 15% Dextrose)
    Injection

    CENTRAL LINE INFUSION ONLY

    500 mL INJECTION PORT CHAMBER
    30% Dextrose Injection USP
    500 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection
    Rx Only

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR
    INSTRUCTIONS ON ACTIVATION

    AFTER MIXING THE PRODUCT
    REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT
    ALTER THE QUALITY AND EFFICACY OF
    THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE
    COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
    DEXTROSE HYDROUS USP 15 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    1600

    1000

    800

    600

    400

    200

    BE-35-04-995

    EXP LOT

    Clinimix Representative Container Label 0338-7011-01

    Container Label

    2B7709L
    NDC0338-7011-01

    2000mL

    CLINIMIX
    5/15

    SULFITE-FREE

    (5% Amino Acids
    in 15% Dextrose)
    Injection

    CENTRAL LINE INFUSION ONLY

    1000 mL INJECTION PORT CHAMBER
    30% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
    ON ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 15 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    2000

    1600

    1000

    800

    600

    400

    200

    BE-35-04-987

    EXP LOT

    Clinimix Representative Container Label 0338-7013-01

    Container Label

    2B7731L
    NDC0338-7013-01

    1000mL

    CLINIMIX
    5/20
    SULFITE-FREE
    (5% Amino Acids

    in 20% Dextrose)
    Injection

    CENTRAL LINE INFUSION ONLY

    500 mL INJECTION PORT CHAMBER
    40% Dextrose Injection USP
    500 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection
    Rx Only

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR
    INSTRUCTIONS ON ACTIVATION

    AFTER MIXING THE PRODUCT
    REPRESENTS 1000 mL

    REFRIGERATED STORAGE IS LIMITED TO
    9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT
    ALTER THE QUALITY AND EFFICACY OF
    THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE
    COMPATIBILITY

    CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
    DEXTROSE HYDROUS USP 20 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    1600

    1000

    800

    600

    400

    200

    BE-35-04-996

    EXP LOT

    Clinimix Representative Container Label 0338-7015-01

    Container Label

    2B7710L
    NDC0338-7015-01

    2000mL

    CLINIMIX
    5/20

    SULFITE-FREE

    (5% Amino Acids
    in 20% Dextrose)
    Injection

    CENTRAL LINE INFUSION ONLY

    1000 mL INJECTION PORT CHAMBER
    40% Dextrose Injection USP

    1000 mL OUTLET PORT CHAMBER
    10% Amino Acid Injection

    Rx Only

    ACTIVATE SEAL AND
    MIX THOROUGHLY BEFORE USE

    SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON
    ACTIVATION

    AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

    REFRIGERATED STORAGE IS LIMITED
    TO 9 DAYS ONCE OVERWRAP IS OPENED

    A SLIGHT YELLOW COLOR DOES NOT ALTER THE
    QUALITY AND EFFICACY OF THIS PRODUCT

    ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

    2D Datamatrix (GS1):
    NDC, LOT, EXP

    2D Datamatrix
    Barcode

    CONTENTS OF EACH 100 mL OF THE ADMIXED
    INJECTION
    DEXTROSE HYDROUS USP 20 g

    ESSENTIAL AMINO ACIDS
    LEUCINE 365 mg
    ISOLEUCINE 300 mg
    VALINE 290 mg
    LYSINE (ADDED AS THE
    HYDROCHLORIDE SALT) 290 mg
    PHENYLALANINE 280 mg
    HISTIDINE 240 mg
    THREONINE 210 mg
    METHIONINE 200 mg
    TRYPTOPHAN 90 mg

    NONESSENTIAL AMINO ACIDS
    ALANINE 1035 mg
    ARGININE 575 mg
    GLYCINE 515 mg
    PROLINE 340 mg
    SERINE 250 mg
    TYROSINE 20 mg

    mEq/L
    ACETATE 42
    CHLORIDE 20

    BALANCED BY IONS FROM AMINO ACIDS
    pH ADJUSTED WITH GLACIAL ACETIC ACID
    AND HYDROCHLORIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    STORE AT ROOM TEMPERATURE (25°C/77°F)
    IN UNOPENED OVERWRAP

    AVOID EXCESSIVE HEAT

    PROTECT FROM FREEZING

    SEE PRESCRIBING INFORMATION

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN BELGIUM

    2000

    1600

    1000

    800

    600

    400

    200

    BE-35-04-988

    EXP LOT

  • INGREDIENTS AND APPEARANCE
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1133
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1133-031000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1089
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1089-042000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1134
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1134-031000 mL in 1 BAG; Type 0: Not a Combination Product03/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073403/20/2012
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1091
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1091-042000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1137
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1137-031000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1099
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1099-042000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1138
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1138-031000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-1101
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-1101-042000 mL in 1 BAG; Type 0: Not a Combination Product09/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0198
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE438 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE336 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE348 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE360 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE348 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE288 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE252 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN108 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1242 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE618 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE690 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE408 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE300 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE24 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0198-066 in 1 CARTON09/21/2020
    1NDC:0338-0198-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0188
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE584 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE448 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE464 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE320 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE480 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE464 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE384 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE336 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN144 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1656 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE920 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE544 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE400 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE32 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0188-066 in 1 CARTON09/21/2020
    1NDC:0338-0188-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0194
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE584 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE448 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE464 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE320 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE480 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE464 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE384 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE336 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN144 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1656 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE824 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE920 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE544 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE400 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE32 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0194-044 in 1 CARTON09/21/2020
    1NDC:0338-0194-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0180
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE584 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE448 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE464 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE320 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE480 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE464 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE384 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE336 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN144 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1656 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE824 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE920 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE544 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE400 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE32 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0180-066 in 1 CARTON09/21/2020
    1NDC:0338-0180-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0184
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE584 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE448 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE464 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE320 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE480 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE464 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE384 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE336 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN144 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1656 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE824 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE920 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE544 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE400 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE32 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0184-044 in 1 CARTON09/21/2020
    1NDC:0338-0184-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073409/29/1997
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7001
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7001-066 in 1 CARTON07/15/2024
    1NDC:0338-7001-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7003
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7003-044 in 1 CARTON07/15/2024
    1NDC:0338-7003-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7005
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7005-066 in 1 CARTON07/15/2024
    1NDC:0338-7005-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7007
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE311 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE238 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE247 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE170 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE255 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE247 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE204 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE179 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN77 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE880 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE438 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE489 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE289 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE213 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE17 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7007-044 in 1 CARTON07/15/2024
    1NDC:0338-7007-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7009
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7009-066 in 1 CARTON07/15/2024
    1NDC:0338-7009-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7011
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7011-044 in 1 CARTON07/15/2024
    1NDC:0338-7011-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7013
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7013-066 in 1 CARTON07/15/2024
    1NDC:0338-7013-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    CLINIMIX 
    leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-7015
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE365 mg  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE280 mg  in 100 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE290 mg  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE200 mg  in 100 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE300 mg  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE290 mg  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE240 mg  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE210 mg  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN90 mg  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE1035 mg  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE515 mg  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE575 mg  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE340 mg  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE250 mg  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE20 mg  in 100 mL
    DEXTROSE (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    NITROGEN (UNII: N762921K75)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7015-044 in 1 CARTON07/15/2024
    1NDC:0338-7015-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02073407/15/2024
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation189326168ANALYSIS(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , MANUFACTURE(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , LABEL(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , PACK(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , STERILIZE(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764ANALYSIS(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , MANUFACTURE(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , LABEL(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , PACK(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101) , STERILIZE(0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter SA370353835ANALYSIS(0338-0198, 0338-0188, 0338-0194, 0338-0180, 0338-0184, 0338-7001, 0338-7003, 0338-7005, 0338-7007, 0338-7009, 0338-7011, 0338-7013, 0338-7015) , MANUFACTURE(0338-0198, 0338-0188, 0338-0194, 0338-0180, 0338-0184, 0338-7001, 0338-7003, 0338-7005, 0338-7007, 0338-7009, 0338-7011, 0338-7013, 0338-7015) , LABEL(0338-0198, 0338-0188, 0338-0194, 0338-0180, 0338-0184, 0338-7001, 0338-7003, 0338-7005, 0338-7007, 0338-7009, 0338-7011, 0338-7013, 0338-7015) , PACK(0338-0198, 0338-0188, 0338-0194, 0338-0180, 0338-0184, 0338-7001, 0338-7003, 0338-7005, 0338-7007, 0338-7009, 0338-7011, 0338-7013, 0338-7015) , STERILIZE(0338-0198, 0338-0188, 0338-0194, 0338-0180, 0338-0184, 0338-7001, 0338-7003, 0338-7005, 0338-7007, 0338-7009, 0338-7011, 0338-7013, 0338-7015)