Label: DIANEAL PD-2 WITH DEXTROSE- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
DIANEAL LOW CALCIUM WITH DEXTROSE- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

  • NDC Code(s): 0941-0409-01, 0941-0409-05, 0941-0409-06, 0941-0409-07, view more
    0941-0411-04, 0941-0411-05, 0941-0411-06, 0941-0411-07, 0941-0411-11, 0941-0413-01, 0941-0413-04, 0941-0413-05, 0941-0413-06, 0941-0413-07, 0941-0415-01, 0941-0415-04, 0941-0415-05, 0941-0415-06, 0941-0415-07, 0941-0424-51, 0941-0424-52, 0941-0424-53, 0941-0424-55, 0941-0426-52, 0941-0426-53, 0941-0426-55, 0941-0427-52, 0941-0427-53, 0941-0427-55, 0941-0429-52, 0941-0429-53, 0941-0429-55, 0941-0430-51, 0941-0430-52, 0941-0430-53, 0941-0430-55, 0941-0433-51, 0941-0433-52, 0941-0433-53, 0941-0433-55, 0941-0457-01, 0941-0457-02, 0941-0457-05, 0941-0457-08, 0941-0459-01, 0941-0459-02, 0941-0459-05, 0941-0459-08, 0941-0484-01, 0941-0487-01, 0941-0490-01
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 21, 2019

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 DIANEAL peritoneal dialysis solutions safely and effectively. See full prescribing information for DIANEAL solutions

    DIANEAL (dextrose) peritoneal dialysis solution
    Initial U.S. Approval: 1981
    DIANEAL PD-2 (dextrose) peritoneal dialysis solution
    Initial U.S. Approval: 1992
    DIANEAL LOW CALCIUM (dextrose) peritoneal dialysis solution
    Initial U.S. Approval: 1992

    INDICATIONS AND USAGE

    For management of acute or chronic renal failure. (1)

    DOSAGE AND ADMINISTRATION

    For intraperitoneal administration only. (2)

    DOSAGE FORMS AND STRENGTHS

    DIANEAL solutions are available in multiple combinations of ingredients and in composition, calculated osmolarity, pH, and ionic concentrations. See full prescribing information for detailed descriptions of each formulation. (3)

    CONTRAINDICATIONS

    Pre-existing severe lactic acidosis (4)

    WARNINGS AND PRECAUTIONS

    Encapsulating peritoneal sclerosis (5.1)
    Peritonitis: Initiate appropriate antimicrobial therapy (5.1)
    Monitor for lactic acidosis in patients at risk (5.2)
    Monitor for electrolyte, fluid, and nutrition imbalances (5.4)

    ADVERSE REACTIONS

    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.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 11/2019

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Basic Dosing Information

    DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration..

    Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based on the patient’s clinical condition, fluid, electrolyte and specific needs. The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m2 for adults.

    DIANEAL peritoneal dialysis solutions are intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD and APD system preparation.

    Product Selection

    To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see Dosage Forms and Strengths (3)].

    2.2 Adding Medications

    If the resealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added.

    To add a medication:

    1.
    Put on mask. Clean and/or disinfect hands.
    2.
    Prepare medication port site using aseptic technique.
    3.
    Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive.
    4.
    Reposition container with container ports up and evacuate medication port by squeezing and tapping it.
    5.
    Mix solution and additive thoroughly.

    2.3 Directions for Use

    Warming

    DIANEAL peritoneal dialysis solution can be warmed to 37°C (98.6°F). Only dry heat should be used. For CAPD, it is best to warm solutions within the overwrap using a heating pad. Do not immerse DIANEAL solutions in water for warming. Do not use a microwave oven to warm DIANEAL solutions.

    To Open

    To open, tear the overwrap down at the slit and remove the solution container. Do not use sharp objects to remove the overwrap.

    Product Inspection

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. The opacity should diminish gradually.

    Inspect the bag connector to ensure the tip protector (pull ring or blue pull tip) is attached. Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL solution for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken. Do not use DIANEAL solution if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

    For DIANEAL solutions in ULTRABAG containers, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units.

    CAPD therapy using ULTRABAG containers

    Select appropriate formulation from Table 1.

    Put on mask. Clean and/or disinfect hands. Using aseptic technique;

    1.
    Uncoil tubing and drain bag, ensuring that the transfer set is closed.
    2.
    Break the connector (Y-set) frangible.
    3.
    Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed.
    4.
    Immediately attach the solution container to patient connector (transfer set).
    5.
    Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen.
    6.
    Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set.
    7.
    Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete.
    8.
    Open transfer set to fill. When fill complete, close transfer set.
    9.
    Disconnect ULTRABAG container from transfer set and apply MINICAP disconnect cap.
    10.
    Upon completion of therapy, discard any unused portion.

    APD therapy using AMBU-FLEX containers with pull rings or plastic containers with blue pull tips or pull rings

    Select appropriate formulation from Table 1, 2 or 3.

    Put on mask. Clean and/or disinfect hands. Using aseptic technique;

    1.
    Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed.
    2.
    Immediately attach the solution container to an appropriate automated peritoneal dialysis set.
    3.
    Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis.
    4.
    Upon completion of therapy, discard any unused portion.
  • 3 DOSAGE FORMS AND STRENGTHS

    DIANEAL peritoneal dialysis solution is formulated with the following ionic concentrations:

    Table 1 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX Container with pull ring for APD therapy
    Ionic Concentration
    (mEq/L)
    OSMOLARITY
    (mOsmol/L) (calc)
    pHSodiumCalciumMagnesiumChlorideLactate

    DIANEAL PD-2
    1.5% Dextrose

    346

    5.2
    (4.0 to 6.5)

    132

    3.5

    0.5

    96

    40

    DIANEAL PD-2
    2.5% Dextrose

    396

    5.2
    (4.0 to 6.5)

    132

    3.5

    0.5

    96

    40

    DIANEAL PD-2
    4.25% Dextrose

    485

    5.2
    (4.0 to 6.5)

    132

    3.5

    0.5

    96

    40

    DIANEAL Low Calcium
    (2.5 mEq/L)
    1.5% Dextrose

    344

    5.2
    (4.0 to 6.5)

    132

    2.5

    0.5

    95

    40

    DIANEAL Low Calcium
    (2.5 mEq/L)
    2.5% Dextrose

    395

    5.2
    (4.0 to 6.5)

    132

    2.5

    0.5

    95

    40

    DIANEAL Low Calcium
    (2.5 mEq/L)
    4.25% Dextrose

    483

    5.2
    (4.0 to 6.5)

    132

    2.5

    0.5

    95

    40

    Table 2 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy
    Ionic Concentration
    (mEq/L)
    OSMOLARITY
    (mOsmol/L) (calc)
    pHSodiumCalciumMagnesiumChlorideLactate

    DIANEAL Low Calcium
    (2.5 mEq/L)
    1.5% Dextrose

    344

    5.0 to 6.5

    132

    2.5

    0.5

    95

    40

    DIANEAL Low Calcium
    (2.5 mEq/L)
    2.5% Dextrose

    395

    5.0 to 6.5

    132

    2.5

    0.5

    95

    40

    DIANEAL Low Calcium
    (2.5 mEq/L)
    4.25% Dextrose

    483

    5.0 to 6.5

    132

    2.5

    0.5

    95

    40

    Table 3 – DIANEAL PD-2 and DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with pull ring for APD therapy
    OSMOLARITY
    (mOsmol/L) (calc)
    pHIonic Concentration
    (mEq/L)
    SodiumCalciumMagnesiumChlorideLactate

    DIANEAL PD-2

    1.5% Dextrose

    346

    5.0 to 5.6

    132

    3.5

    0.5

    96

    40

    DIANEAL PD-2

    2.5% Dextrose

    396

    5.0 to 5.6

    132

    3.5

    0.5

    96

    40

    DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose

    344

    5.0 to 5.6

    132

    2.5

    0.5

    95

    40

    DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose

    395

    5.0 to 5.6

    132

    2.5

    0.5

    95

    40

  • 4 CONTRAINDICATIONS

    DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Peritonitis and Encapsulating Peritoneal Sclerosis

    Peritonitis has been associated with DIANEAL peritoneal dialysis solution use. Following use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy.

    Encapsulating Peritoneal Sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and has been reported in patients using DIANEAL solutions.

    5.2 Lactic Acidosis

    Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute renal failure, hepatic failure, inborn errors of metabolism, and treatment with drugs such as nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions. Use of DIANEAL solutions in patients with severe lactic acidosis is contraindicated [see Contraindications (4)].

    5.3 Overinfusion

    Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat overinfusion.

    5.4 Electrolyte, Fluid, and Nutrition Imbalances

    Peritoneal dialysis may affect a patient’s protein, water-soluble vitamin, potassium, bicarbonate, calcium, and magnesium levels and volume status. Monitor hematology, electrolytes, blood chemistry and fluid status periodically and take appropriate clinical action.

    Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, addition of potassium chloride (up to a concentration of 4 mEq/L) to the solution may be necessary to prevent severe hypokalemia. Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion and hypovolemic shock.

    5.5 Hyperglycemia

    DIANEAL solutions contain dextrose and may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation or modification of antidiabetic therapy during treatment with DIANEAL solutions. Monitor blood glucose.

  • 6 ADVERSE REACTIONS

    The following adverse reactions are discussed elsewhere in the label:

    Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1)]

    Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4)]

    6.1 Clinical Trials Experience

    There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL peritoneal dialysis solutions.

    6.2 Post-Marketing Experience

    The following adverse experiences have been identified during post-approval use of DIANEAL solutions or in conjunction with performing the peritoneal dialysis procedure. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneal dialysis.

    INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection

    METABOLISM AND NUTRITION DISORDERS: Hypovolemia, Hypervolemia, Fluid retention, Hypokalemia, Hyponatremia, Dehydration, Hypochloremia

    VASCULAR DISORDERS: Hypotension, Hypertension

    RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea

    GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Peritonitis, Peritoneal cloudy effluent, Vomiting, Diarrhea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort

    SKIN AND SUBCUTANEOUS DISORDERS: Stevens-Johnson syndrome, Urticaria, Rash, (including pruritic, erythematous and generalized), Pruritus

    MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Myalgia, Muscle spasms, Musculoskeletal pain

    GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Generalized edema, Pyrexia, Malaise, Infusion site pain, Catheter related complication

  • 7 DRUG INTERACTIONS

    As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary.

    Diabetic patients may require dosage adjustments of insulin or other treatments for hyperglycemia [see Warnings and Precautions (5.5)].

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    DIANEAL peritoneal dialysis solution is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriate monitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DIANEAL solutions.

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

    8.2 Lactation

    The components of DIANEAL solutions are excreted in human milk.

    8.4 Pediatric Use

    Safety and effectiveness have been established based on published clinical data. No adequate and well-controlled studies have been conducted with DIANEAL solutions in pediatric patients.

    8.5 Geriatric Use

    Safety and effectiveness have been established based on published clinical data.

  • 10 OVERDOSAGE

    There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

  • 11 DESCRIPTION

    DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents.

    DIANEAL solutions are hyperosmolar solutions.

    Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX/Plastic Container with pull ring for APD therapy
    Composition/100 mL
    *Dextrose, Hydrous, USPSodium Chloride, USP (NaCl)Sodium Lactate (C3H5NaO3)Calcium Chloride, USP (CaCl2•2H2O)Magnesium Chloride, USP (MgCl2•6H2O)

    DIANEAL PD-2
    1.5% Dextrose

    1.5 g

    538 mg

    448 mg

    25.7 mg

    5.08 mg

    DIANEAL PD-2
    2.5% Dextrose

    2.5 g

    538 mg

    448 mg

    25.7 mg

    5.08 mg

    DIANEAL PD-2
    4.25% Dextrose

    4.25 g

    538 mg

    448 mg

    25.7 mg

    5.08 mg

    DIANEAL Low Calcium
    (2.5 mEq/L)
    1.5% Dextrose

    1.5 g

    538 mg

    448 mg

    18.3 mg

    5.08 mg

    DIANEAL Low Calcium
    (2.5 mEq/L)
    2.5% Dextrose

    2.5 g

    538 mg

    448 mg

    18.3 mg

    5.08 mg

    DIANEAL Low Calcium
    (2.5 mEq/L)
    4.25% Dextrose

    4.25 g

    538 mg

    448 mg

    18.3 mg

    5.08 mg

    Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy
    Composition/100 mL
    *Dextrose, HydrousSodium Chloride (NaCl)Sodium Lactate (C3H5NaO3)Calcium Chloride (CaCl2•2H2O)Magnesium Chloride (MgCl2•6H2O)

    DIANEAL Low Calcium
    (2.5 mEq/L)
    1.5% Dextrose

    1.5 g

    538 mg

    448 mg

    18.4 mg

    5.08 mg

    DIANEAL Low Calcium
    (2.5 mEq/L)
    2.5% Dextrose

    2.5 g

    538 mg

    448 mg

    18.4 mg

    5.08 mg

    DIANEAL Low Calcium
    (2.5 mEq/L)
    4.25% Dextrose

    4.25 g

    538 mg

    448 mg

    18.4 mg

    5.08 mg

    Structural Formula Dextrose Hydrous USP

    The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly.

    Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    DIANEAL peritoneal dialysis solutions are a pharmacologically inactive, hypertonic peritoneal dialysis solution containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DIANEAL solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL solutions contain electrolytes to facilitate the correction of electrolyte abnormalities. DIANEAL solutions contain a buffer, lactate, to help normalize acid-base abnormalities.

    12.3 Pharmacokinetics

    Absorption

    Glucose is rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to the high glucose concentration gradient between DIANEAL solutions compared to blood capillary glucose level. Absorption per unit time will be the highest at the start of an exchange and decreases over time. The rate of glucose absorption will be dependent upon the transport characteristics of the patient’s peritoneal membrane as determined by a peritoneal equilibration test (PET). Glucose absorption will also depend upon the concentration of glucose used for the exchange and the length of the dwell. Transport of other molecules will be dependent upon the molecular size of the solute, the concentration gradient, and the effective peritoneal surface area as determined by the PET.

    Metabolism and Elimination

    Glucose is metabolized by normal cellular pathways (i.e., glycolysis). Metabolism of lactate occurs in the liver and results in the generation of the bicarbonate. Glucose not absorbed during PD exchange procedure is removed by drainage of the PD solution from the peritoneal cavity.

    Drug Interaction Studies

    Heparin

    No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with DIANEAL solutions.

    Antibiotics

    No formal clinical drug interaction studies have been performed. In vitro studies of the following medications have demonstrated stability with DIANEAL solutions: amphotericin B, ampicillin, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, sulfamethoxazole/trimethoprim, ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 6-7:

    Table 6 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapy

    Container

    Fill Volume (mL)

    Container Size (mL)

    Product Code

    NDC

    ULTRABAG
    Container

    DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose

    2000

    2500

    3000

    2000

    3000

    5000

    5B9866

    5B9868

    5B9857

    0941-0426-52

    0941-0426-53

    0941-0426-55

    DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose

    2000

    2500

    3000

    2000

    3000

    5000

    5B9876

    5B9878

    5B9858

    0941-0427-52

    0941-0427-53

    0941-0427-55

    DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose

    2000

    2500

    3000

    2000

    3000

    5000

    5B9896

    5B9898

    5B9859

    0941-0429-52

    0941-0429-53

    0941-0429-55

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose

    1500

    2000

    2500

    3000

    2000

    2000

    3000

    5000

    5B9765

    5B9766

    5B9768

    5B9757

    0941-0424-51

    0941-0424-52

    0941-0424-53

    0941-0424-55

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose

    1500

    2000

    2500

    3000

    2000

    2000

    3000

    5000

    5B9775

    5B9776

    5B9778

    5B9758

    0941-0430-51

    0941-0430-52

    0941-0430-53

    0941-0430-55

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose

    1500

    2000

    2500

    3000

    2000

    2000

    3000

    5000

    5B9795

    5B9796

    5B9798

    5B9759

    0941-0433-51

    0941-0433-52

    0941-0433-53

    0941-0433-55

    Table 7 - DIANEAL Peritoneal Dialysis Solutions for APD therapy

    Container

    Fill Volume (mL)

    Container Size (mL)

    Product Code

    NDC

    AMBU-FLEX / Plastic Container with pull ring

    DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose

    1000

    2000

    3000

    5000

    6000

    1000

    3000

    3000

    6000

    6000

    L5B5163

    L5B5166

    L5B5169

    L5B5193

    L5B9710

    0941-0411-05

    0941-0411-06

    0941-0411-04

    0941-0411-07

    0941-0411-11

    DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose

    1000

    2000

    3000

    5000

    6000

    1000

    3000

    3000

    6000

    6000

    L5B5173

    L5B5177

    L5B5179

    L5B5194

    L5B9711

    0941-0413-05

    0941-0413-06

    0941-0413-04

    0941-0413-07

    0941-0413-01

    DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose

    1000

    2000

    3000

    5000

    6000

    1000

    3000

    3000

    6000

    6000

    L5B5183

    L5B5187

    L5B5189

    L5B5195

    L5B9712

    0941-0415-05

    0941-0415-06

    0941-0415-04

    0941-0415-07

    0941-0415-01

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5%Dextrose

    2000

    3000

    5000

    6000

    3000

    3000

    6000

    6000

    L5B4825

    L5B9901

    L5B4826

    L5B9770

    0941-0409-06

    0941-0409-05

    0941-0409-07

    0941-0409-01

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose

    2000

    3000

    5000

    6000

    3000

    3000

    6000

    6000

    L5B9727

    L5B9902

    L5B5202

    L5B9771

    0941-0457-08

    0941-0457-02

    0941-0457-05

    0941-0457-01

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose

    2000

    3000

    5000

    6000

    3000

    3000

    6000

    6000

    L5B9747

    L5B9903

    L5B5203

    L5B9772

    0941-0459-08

    0941-0459-02

    0941-0459-05

    0941-0459-01

    Plastic container with blue pull tip

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose

    5000

    5000

    EZPB5245R

    0941-0484-01

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose

    5000

    5000

    EZPB5255R

    0941-0487-01

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose

    5000

    5000

    EZPB5265R

    0941-0490-01

    All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.

    Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.

    Store in moisture barrier overwrap and in carton until ready to use.

  • 17 PATIENT COUNSELING INFORMATION

    Inspection: Advise patients to inspect DIANEAL peritoneal dialysis solutions before use, and not to use if the solution is cloudy, discolored, contains particulate matter or if there is evidence of leakage.

    Administration: Advise patients on proper administration and the importance of using aseptic technique throughout the entire PD procedure. Advise patients only to use dry heat to warm solution to about 37°C (98°F) and not to microwave or submerge in water.

    Peritonitis: Advise patients to seek medical attention if they experience signs or symptoms of peritonitis.

  • SPL UNCLASSIFIED SECTION

    Baxter, Ambu-Flex, Dianeal, MiniCap and UltraBag are trademarks of Baxter International Inc.

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    Printed in USA

    0719001298

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 0941-0411-11 Representative Container Label

    NDC 0941-0411-11 (07-25-00-0740) Container Label

     L5B9710 6000 mL
    NDC 0941-0411-11(APPROX 225 mL EXCESS)

    BaxterLogo

    Dianeal PD-2
    Peritoneal Dialysis Solution
    with1.5% Dextrose

    EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
    USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
    LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
    MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM
    - 0.5 CHLORIDE - 96 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    CAUTIONS SQUEEZE AND INSPECT INNER
    BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE
    AVOID EXCESSIVE HEAT SEE INSERT

    Ambu-Flex II CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    PD-2 1.5% Dextrose

    Bar Code
    (01)00309410411117

    NDC 0941-0413-07 Representative Container Label

    NDC 0941-0413-07 (07-25-00-0677) Container Label

    L5B5194 5000 mL
    NDC 0941-0413-07 (APPROX 150 mL EXCESS)

    BaxterLogo

    Dianeal PD-2
    Peritoneal Dialysis Solution
    with 2.5% Dextrose

    EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
    CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
    CHLORIDE - 96 LACTATE - 40
    OSMOLARITY - 396 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    CAUTIONS SQUEEZE AND INSPECT INNER
    BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE
    AVOID EXCESSIVE HEAT SEE INSERT

    Ambu-Flex II CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    PD-2 2.5% Dextrose

    Bar Code
    (01) 00309410413074

    NDC 0941-0415-06 Representative Container Label

    NDC 0941-0415-06 (07-25-56-591) Container Label

    L5B5187 2000 mL
    NDC 0941-0415-06 (APPROX 80 mL EXCESS)
    3000 mL NOMINAL SIZE CONTAINER

    BaxterLogo

    Dianeal PD-2
    Peritoneal Dialysis Solution
    with 4.25% Dextrose

    EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
    CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
    CHLORIDE - 96 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    WARNING EXTENSIVE USE OF THIS SOLUTION
    DURING ONE PERITONEAL DIALYSIS PROCEDURE CAN
    RESULT IN SIGNIFICANT REMOVAL OF WATER FROM
    THE PATIENT

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
    LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE
    AVOID EXCESSIVE HEAT SEE INSERT

    Ambu-Flex II CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    PD-2 4.25% Dextrose 

    NDC 0941-0409-07 Representative Container Label

    NDC 0941-0409-07 (07-25-00-0676) Container Label

    L5B4826 5000 mL
    NDC 0941-0409-07 (APPROX 150 mL EXCESS)

    BaxterLogo

    Dianeal
    Low Calcium (2.5 mEq/L)
    Peritoneal Dialysis Solution
    with 1.5% Dextrose

    EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
    USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
    LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg
    MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM -
    0.5 CHLORIDE - 95 LACTATE - 40
    OSMOLARITY - 344 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD
    IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP
    AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
    TO USE AVOID EXCESSIVE HEAT SEE INSERT

    Ambu-Flex II CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    Low Calcium 1.5% Dextrose

    Bar Code
    (01)00309410409077

    NDC 0491-0457-08 Representative Container Label

    NDC 0941-0457-08 (07-25-00-0739) Container Label

    L5B9727 2000 mL
    NDC 0941-0457-08 (APPROX 80 mL EXCESS)
    3000 mL NOMINAL SIZE CONTANER

    BaxterLogo

    Dianeal
    Low Calcium (2.5 mEq/L)
    Peritoneal Dialysis Solution
    with 2.5% Dextrose

    EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
    CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
    CHLORIDE - 95 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
    LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE
    AVOID EXCESSIVE HEAT SEE INSERT

    Ambu-Flex II CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    Low Calcium 2.5% Dextrose

    Bar Code
    (01)00309410457085

    NDC 0941-0459-08 Representative Container Label

    NDC 0941-0459-08 Container Label

    L5B9747 2000 mL
    NDC 0941-0459-08 (APPROX 80 mL EXCESS)
    3000 mL NOMINAL SIZE CONTANER

    BaxterLogo

    Dianeal
    Low Calcium (2.5 mEq/L)
    Peritoneal Dialysis Solution
    with 4.25% Dextrose

    EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
    CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
    CHLORIDE - 95 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
    LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE
    AVOID EXCESSIVE HEAT SEE INSERT

    Ambu-Flex II CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA 07-25-56-642

    Low Calcium 4.25% Dextrose

    NDC 0941-0426-52 Representative Container Label

    NDC 0941-0426-52 Container Label

    07-25-47-851

    5B9866 2000 mL

    NDC 0941-0426-52 (APPROX 80 mL EXCESS)

    BaxterLogo

    Dianeal PD-2
    Peritoneal Dialysis Solution
    with 1.5% Dextrose

    EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM
    LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
    MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
    CHLORIDE - 96 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    READ PACKAGE INSERT FOR FULL INFORMATION

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    USE AS DIRECTED BY PHYSICIAN

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD
    IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE

    AVOID EXCESSIVE HEAT SEE INSERT

    UltraBag CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL ULTRABAG AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    US PAT NOS 4340049 4346703
    4439188 4573980

    PD-2 1.5% Dextrose

    NDC 0941-0427-52 Representative Container Label

    NDC 0941-0427-52 Container Label

    07-25-47-854
    5B9876 2000 mL

    NDC 0941-0427-52 (APPROX 80 mL EXCESS)

    BaxterLogo
    Dianeal PD-2
    Peritoneal Dialysis Solution
    with 2.5% Dextrose

    EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM
    LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
    MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
    CHLORIDE - 96 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    READ PACKAGE INSERT FOR FULL INFORMATION

    DOSAGE AS DIRECTED BY PHYSICIAN

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD
    IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE

    AVOID EXCESSIVE HEAT SEE INSERT

    UltraBag CCONTAINER PL 146 PLASTIC

    BAXTER DIANEAL ULTRABAG AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    US PAT NOS 4340049 4346703
    4439188 4573980

    PD-2 2.5% Dextrose

    NDC 0941-0429-52 Representative Container Label

    NDC 0941-0429-52 Container Label

    07-25-47-876

    5B9896 2000 mL
    NDC 0941-0429-52 (APPROX 80 mL EXCESS)

    Baxter Logo
    Dianeal PD-2
    Peritoneal Dialysis Solution
    with 4.25% Dextrose

    EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
    CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
    CHLORIDE - 96 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    READ PACKAGE INSERT FOR FULL INFORMATION

    WARNING EXTENSIVE USE OF THIS SOLUTION DURING
    ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
    SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    DOSAGE AS DIRECTED BY A PHYSICIAN

    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
    MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
    ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION
    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
    TEMPERATURE (25°C/77°F) UNTIL READY TO USE
    AVOID EXCESSIVE HEAT SEE INSERT

    UltraBag CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL ULTRABAG AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    US PAT NOS 4340049 4346703
    4439188 4573980

    PD-2 4.25% Dextrose

    NDC 0941-0424-52 Representative Container Label

    NDC 0941-0424-52 Container Label

    07-25-47-842

    5B9766 2000 mL
    NDC 0941-0424-52 (APPROX 80 mL EXCESS)

    BaxterLogo

    Dianeal
    Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
    with 1.5% Dextrose

    EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
    CHLORIDE - 95 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    READ PACKAGE INSET FOR FULL INFORMATION

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    DOSAGE AS DIRECTED BY PHYSICIAN

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD
    IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE

    AVOID EXCESSIVE HEAT SEE INSERT

    UltraBag CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL ULTRABAG AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    US PAT NOS 4340049 4346703
    4439188 4573980

    Low Calcium 1.5% Dextrose

    NDC 0941-0430-52 Representative Container Label

    NDC 0941-0430-52 (07-25-00-0683) Container Label

    5B9776 2000 mL
    NDC 0941-0430-52 (APPROX 80 mL EXCESS)

    BaxterLogo

    Dianeal
    Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
    with 2.5% Dextrose

    EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
    CHLORIDE - 95 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    READ PACKAGE INSET FOR FULL INFORMATION

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    DOSAGE AS DIRECTED BY PHYSICIAN

    CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD
    IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE

    AVOID EXCESSIVE HEAT SEE INSERT

    UltraBag CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL ULTRABAG AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    US PAT NOS 4340049 4346703
    4439188 4573980

    Low Calcium 2.5% Dextrose

    NDC 0941-0433-52 Representative Container Label

    NDC 0941-0433-52 Container Label

    07-25-47-848

    5B9796 2000 mL
    NDC 0941-0433-52 (APPROX 80 mL EXCESS)

    BaxterLogo

    Dianeal
    Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
    with 4.25% Dextrose

    EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
    538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
    CHLORIDE USP pH 5.2 (4.0 TO 6.5)

    mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
    CHLORIDE - 95 LACTATE - 40
    OSMOLARITY - 346 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY
    UNDER THE DIRECTION OF A PHYSICIAN

    READ PACKAGE INSET FOR FULL INFORMATION

    WARNING EXTENSIVE USE OF THIS SOLUTION DURING
    ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
    SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

    DOSAGE AS DIRECTED BY PHYSICIAN

    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
    MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
    ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE

    AVOID EXCESSIVE HEAT SEE INSERT

    UltraBag CONTAINER PL 146 PLASTIC

    BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION

    DEERFIELD IL 60015 USA

    MADE IN USA

    US PAT NOS 4340049 4346703
    4439188 4573980

    Low Calcium 2.5% Dextrose

    NDC 0941-0484-01 Representative Container Label

    NDC 0941-0484-01 Container Label

    EZPB5245R
    NDC 0941-0484-01

    5000 mL
    (APPROX 135 mL EXCESS)

    BAXTER LOGO

    Dianeal
    Low Calcium (2.5 mEq/L)
    Peritoneal Dialysis Solution
    with 1.5% Dextrose

    Low Calcium 1.5% Dextrose

    EACH 100 mL CONTAINS
    448 mg SODIUM LACTATE
    pH 5.0 to 6.5

    1.5 g DEXTROSE HYDROUS
    18.4 mg CALCIUM CHLORIDE

    538 mg SODIUM CHLORIDE
    5.08 mg MAGNESIUM CHLORIDE

    mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
    OSMOLARITY – 344 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

     
    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
    MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
    USE

    AVOID EXCESSIVE HEAT SEE INSERT

    PL 146 PLASTIC

    BAXTER DIANEAL AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN IRELAND

    CB-35-03-813

    NDC 0941-0487-01 Representative Container Label

    0941-0487-01 Container Label

    EZPB5255R
    NDC 0941-0487-01

    5000 mL
    (APPROX 135 mL EXCESS)

    BAXTER LOGO

    Dianeal
    Low Calcium (2.5 mEq/L)
    Peritoneal Dialysis Solution
    with 2.5% Dextrose

    Low Calcium 2.5% Dextrose

    EACH 100 mL CONTAINS
    448 mg SODIUM LACTATE
    pH 5.0 to 6.5

    2.5 g DEXTROSE HYDROUS
    18.4 mg CALCIUM CHLORIDE

    538 mg SODIUM CHLORIDE
    5.08 mg MAGNESIUM CHLORIDE

    mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
    OSMOLARITY – 395 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

     
    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

    PL 146 PLASTIC

    BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

    MADE IN IRELAND

    CB-35-03-814

    NDC 0941-0490-01 Representative Container Label

    NDC 0941-0490-01 Container Label

    EZPB5265R
    NDC 0941-0490-01

    5000 mL
    (APPROX 135 mL EXCESS)

    BAXTER LOGO

    Dianeal
    Low Calcium (2.5 mEq/L)
    Peritoneal Dialysis Solution
    with 4.25% Dextrose

    Low Calcium 4.25% Dextrose

    EACH 100 mL CONTAINS
    448 mg SODIUM LACTATE
    pH 5.0 to 6.5

    4.25 g DEXTROSE HYDROUS
    18.4 mg CALCIUM CHLORIDE

    538 mg SODIUM CHLORIDE
    5.08 mg MAGNESIUM CHLORIDE

    mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
    OSMOLARITY – 483 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

    SEE PACKAGE INSERT FOR DOSAGE INFORMATION

    USE AS DIRECTED BY PHYSICIAN

    FOR INTRAPERITONEAL ADMINISTRATION ONLY

     
    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    Rx ONLY

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

    PL 146 PLASTIC

    BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

    MADE IN IRELAND

    CB-35-03-815

  • INGREDIENTS AND APPEARANCE
    DIANEAL PD-2 WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0411
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0411-051000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    2NDC:0941-0411-062000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    3NDC:0941-0411-075000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    4NDC:0941-0411-043000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    5NDC:0941-0411-116000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL PD-2 WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0413
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0413-051000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    2NDC:0941-0413-062000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    3NDC:0941-0413-075000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    4NDC:0941-0413-016000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    5NDC:0941-0413-043000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL PD-2 WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0415
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0415-051000 mL in 1 BAG; Type 0: Not a Combination Product09/28/1978
    2NDC:0941-0415-062000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    3NDC:0941-0415-043000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    4NDC:0941-0415-075000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    5NDC:0941-0415-016000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0409
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0409-062000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    2NDC:0941-0409-053000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    3NDC:0941-0409-075000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    4NDC:0941-0409-016000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0457
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0457-082000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    2NDC:0941-0457-023000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    3NDC:0941-0457-055000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    4NDC:0941-0457-016000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0459
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0459-082000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    2NDC:0941-0459-023000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    3NDC:0941-0459-055000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    4NDC:0941-0459-016000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL PD-2 WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0426
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0426-522000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    2NDC:0941-0426-532500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    3NDC:0941-0426-553000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016312/04/1992
    DIANEAL PD-2 WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0427
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0427-522000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    2NDC:0941-0427-532500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    3NDC:0941-0427-553000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016312/04/1992
    DIANEAL PD-2 WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0429
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0429-522000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    2NDC:0941-0429-532500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    3NDC:0941-0429-553000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016312/04/1992
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0424
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0424-511500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    2NDC:0941-0424-522000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    3NDC:0941-0424-532500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    4NDC:0941-0424-553000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02018312/04/1992
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0430
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0430-511500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    2NDC:0941-0430-522000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    3NDC:0941-0430-532500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    4NDC:0941-0430-553000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02018312/04/1992
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0433
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0433-511500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    2NDC:0941-0433-522000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    3NDC:0941-0433-532500 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    4NDC:0941-0433-553000 mL in 1 BAG; Type 0: Not a Combination Product12/04/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02018312/04/1992
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0484
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE18.4 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0484-015000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0487
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.4 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0487-015000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0490
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.4 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0490-015000 mL in 1 BAG; Type 0: Not a Combination Product09/27/1978
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01751209/27/1978
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , MANUFACTURE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , LABEL(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , PACK(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , STERILIZE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , API MANUFACTURE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter, S.A. de C.V.810432484ANALYSIS(0941-0409, 0941-0457, 0941-0411, 0941-0413) , MANUFACTURE(0941-0409, 0941-0457, 0941-0411, 0941-0413) , LABEL(0941-0409, 0941-0457, 0941-0411, 0941-0413) , PACK(0941-0409, 0941-0457, 0941-0411, 0941-0413) , STERILIZE(0941-0409, 0941-0457, 0941-0411, 0941-0413) , API MANUFACTURE(0941-0409, 0941-0457, 0941-0411, 0941-0413)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare S.A.988899845ANALYSIS(0941-0484, 0941-0487, 0941-0490) , MANUFACTURE(0941-0484, 0941-0487, 0941-0490) , LABEL(0941-0484, 0941-0487, 0941-0490) , PACK(0941-0484, 0941-0487, 0941-0490) , STERILIZE(0941-0484, 0941-0487, 0941-0490)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter SA370353835ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation189326168ANALYSIS(0941-0424, 0941-0430) , MANUFACTURE(0941-0424, 0941-0430) , LABEL(0941-0424, 0941-0430) , PACK(0941-0424, 0941-0430) , STERILIZE(0941-0424, 0941-0430)