Label: PRISMASOL BGK0/2.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate injection
PRISMASOL BGK4/2.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
PRISMASOL BGK2/3.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
PRISMASOL BGK2/0- magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
PRISMASOL B22GK4/0- magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
PRISMASOL BK0/0/1.2- magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate injection
PRISMASOL BGK4/0/1.2- magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
PHOXILLUM BK4/2.5- calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate injection
PHOXILLUM B22K4/0- magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate injection

  • NDC Code(s): 24571-102-06, 24571-103-06, 24571-105-06, 24571-108-06, view more
    24571-111-06, 24571-113-06, 24571-114-06, 24571-116-06, 24571-117-06
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 1, 2018

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 PRISMASOL and PHOXILLUM safely and effectively. See full prescribing information for PRISMASOL and PHOXILLUM.

    PRISMASOL renal replacement solution
    PRISMASOL Initial U.S. Approval: 2006

    PHOXILLUM renal replacement solution
    PHOXILLUM Initial U.S. Approval: 2015

    INDICATIONS AND USAGE

    PRISMASOL and PHOXILLUM solutions are indicated:

    As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialyzable substances (1)

    DOSAGE AND ADMINISTRATION

    Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance (2.2)
    Solution must be mixed prior to use (2.2)
    Use only with extracorporeal dialysis equipment appropriate for CRRT (2.3)

    DOSAGE FORMS AND STRENGTHS

    PRISMASOL and PHOXILLUM are available in multiple combinations of ingredients and in multiple variations of strengths. See full Prescribing Information for detailed descriptions of each formulation. (2, 3, 11)

    CONTRAINDICATIONS

    Known hypersensitivities to PRISMASOL and PHOXILLUM solutions (4)

    WARNINGS AND PRECAUTIONS

    Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions (5.1)
    Treatment may affect glucose levels. Monitor blood glucose levels.
    Antidiabetic therapy adjustment or other corrective measures may be required during treatment (5.2)

    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

    Revised: 11/2018

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Administration Instructions

    Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration.

    Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT.

    The prepared solution is for single patient use only.

    Aseptic technique should be used throughout administration to the patient.

    Discard any unused solution.

    2.2 Dosing Considerations

    PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration (2.3)]:

    Small compartment A (250 mL) containing an electrolyte solution, and
    Large compartment B (4750 mL) containing the buffer solution.

    See Table 1 for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions (total volume is 5 Liters).

    Table 1: Concentrations of Active Ingredients in the 7 PRISMASOL and 2 PHOXILLUM Replacement Solutions after Mixing
    Ca2+
    mEq/L
    HCO3-
    mEq/L
    K+
    mEq/L
    Mg2+
    mEq/L
    Na+
    mEq/L
    HPO42-
    mmol/L
    Cl-
    mEq/L
    Lactate
    mEq/L
    Dextrose
    mg/dL
    Osmolarity
    mOsm/L
    Ca2+ = calcium, HCO3- = bicarbonate, K+ = potassium, Mg2+ = magnesium, Na+ = sodium, HPO42- = phosphate, Cl- = chloride; osmolarity is estimated

    PRISMASOL Replacement Solutions

    BGK0/2.5

    2.5

    32

    0

    1.5

    140

    0

    109

    3

    100

    292

    BGK4/2.5

    2.5

    32

    4

    1.5

    140

    0

    113

    3

    100

    300

    BGK2/3.5

    3.5

    32

    2

    1

    140

    0

    111.5

    3

    100

    296

    BGK2/0

    0

    32

    2

    1

    140

    0

    108

    3

    100

    291

    B22GK4/0

    0

    22

    4

    1.5

    140

    0

    120.5

    3

    100

    296

    BGK4/0/1.2

    0

    32

    4

    1.2

    140

    0

    110.2

    3

    100

    295

    BK0/0/1.2

    0

    32

    0

    1.2

    140

    0

    106.2

    3

    0

    282

    PHOXILLUM Replacement Solutions

    BK4/2.5

    2.5

    32

    4

    1.5

    140

    1

    114.5

    0

    0

    294

    B22K4/0

    0

    22

    4

    1.5

    140

    1

    122

    0

    0

    290

    The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit:

    Before (pre-dilution) the hemofilter or hemodiafilter,
    After (post-dilution) the hemofilter or hemodiafilter, or
    Before and after the hemofilter or hemodiafilter.

    2.3 Preparing the Solution

    Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear.

    The solution may be warmed to 37°C/98.6°F prior to removing the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter.

    The solutions are supplied in two different two-compartment bags made of polyolefin with a peel seal separating compartment A and B (see Figure 1).

    Follow the instructions below when connecting the solution bags for correct use of the access ports.

    Instructions for preparing solutions supplied in a two-compartment, polyolefin bag with a peel seal:

    Figure 1

    Figure 1

    Figure 2Figure 2

    Step 1 Immediately before use, remove the overwrap from the bag and mix the solutions in the two different compartments. After removing the overwrap, inspect the bag for leakage by pressing firmly on the bag. Discard the bag if any leakage is detected since sterility cannot be assured. As soon as the overwrap is removed, the reconstitution of compartments A and B should be done and the mixed solution should be used immediately.

    After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment.

    Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal. (See Figure 2 beside)

    Figure 3
    Figure 3

    Step 2 Squeeze with both hands on the large compartment until the peel seal between the two compartments is entirely open. Shake gently to mix. (See Figure 3 beside)

    The solution is now ready to use and the bag can be hung on the equipment.

    Figure 4aFigure 4a

    Step 3 The replacement line may be connected to the bag through either of the luer connector or the injection connector (spike connector).

    Step 3a The luer connector is a needle-less and swabbable connector. Remove the cap with a twist and pull motion, and connect the male luer lock on the replacement line to the female luer receptor on the bag. (See Figure 4a beside)

    Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely during use.

    When the replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop.

    Figure 4b

    Figure 4b

    Step 3b If the injection connector (spike connector) is used, first remove the snap-off cap. Then introduce the replacement line spike through the rubber septum of the bag connector. (See Figure 4b beside)

    Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.

    2.4 Adding Drugs to the Solutions

    After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, administer drugs other than phosphate through a different access line.

    When introducing drugs, use aseptic techniques and mix thoroughly prior to connecting the solution bag to the extracorporeal circuit.

    Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

    Phosphate: Up to 1.2 mmol/L of phosphate can be added to the bag as potassium phosphate or sodium phosphate. The total potassium concentration of PRISMASOL solution should not exceed 4 mEq/L. Use sodium phosphate to add phosphate if the total potassium concentration in PRISMASOL solution is 4 mEq/L.

    PHOXILLUM Solutions:

    Phosphate: Phosphate up to 0.2 mmol/L may be added to the solution. Use sodium phosphate if adding phosphate to bag. The total phosphate concentration should not exceed 1.2 mmol/L.

  • 3 DOSAGE FORMS AND STRENGTHS

    See Table 1 for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2)].

  • 4 CONTRAINDICATIONS

    PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Electrolyte and Volume Abnormalities

    PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [see Dosage and Administration (2)].

    PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

    5.2 Blood Glucose Abnormalities

    The use of PRISMASOL and PHOXILLUM replacement solutions can affect blood glucose levels resulting in hypo- or hyper-glycemia depending upon the dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or other corrective measures during treatment.

  • 6 ADVERSE REACTIONS

    The following adverse reactions have been identified during post approval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are 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.

    Metabolic acidosis
    Hypotension
    Acid-base disorders
    Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia
    Fluid imbalance
  • 7 DRUG INTERACTIONS

    As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

    7.1 Citrate

    When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions.

    The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    Clinical Considerations

    Maintenance of normal acid-base balance is important for fetal well-being.

    8.2 Lactation

    Risk Summary

    The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant.

    8.4 Pediatric Use

    Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration studies in pediatric patients, including a study of newborns to 17 years old.

    8.5 Geriatric Use

    The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

  • 11 DESCRIPTION

    PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain:

    Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2 • 2H2O).

    Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2 • 6H2O).

    Sodium chloride, USP, is chemically designated NaCl.

    Potassium chloride, USP, is chemically designated KCl.

    Sodium bicarbonate, USP, is chemically designated NaHCO3.

    Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6 • H2O).

    Lactic acid, USP, is chemically designated CH3CH(OH)COOH.

    Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4 • 2H2O)

    Table 2 - Compartment Composition (Before Mixing)
    Compartment A (g/L)Compartment B (g/L)
    Calcium Chloride ∙ 2H2OMagnesium Chloride ∙ 6H2ODextrose anhydrous (as monohydrate)Lactic AcidSodium ChlorideSodium bicarbonatePotassium ChlorideSodium Phosphate ∙ 2H2O

    PRISMASOL SOLUTIONS

    BGK 0/2.5

    3.68

    3.05

    20 (22)

    5.40

    6.46

    3.09

    0

    0

    BGK 4/2.5

    3.68

    3.05

    20 (22)

    5.40

    6.46

    3.09

    0.314

    0

    BGK 2/3.5

    5.15

    2.03

    20 (22)

    5.40

    6.46

    3.09

    0.157

    0

    BGK 2/0

    0

    2.03

    20 (22)

    5.40

    6.46

    3.09

    0.157

    0

    B22GK 4/0

    0

    3.05

    20 (22)

    5.40

    7.07

    2.21

    0.314

    0

    BK 0/0/1.2

    0

    2.44

    0 (0)

    5.40

    6.46

    3.09

    0

    0

    BGK 4/0/1.2

    0

    2.44

    20 (22)

    5.40

    6.46

    3.09

    0.314

    0

    PHOXILLUM SOLUTIONS

    BK 4/2.5

    3.68

    3.05

    0 (0)

    0

    6.34

    3.09

    0.314

    0.187

    B22K 4/0

    0

    3.05

    0 (0)

    0

    6.95

    2.21

    0.314

    0.187

    The pH of the final solution is in the range of 7.0 to 8.5.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations.

    PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

    12.3 Pharmacokinetics

    The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient's clinical condition, metabolic status, and residual renal function.

    The elimination and replacement of water, electrolytes and buffer depend on the patient's electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal.

    The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11)].

    Container

    Fill Volume

    NDC

    PRISMASOL Solutions

    PRISMASOL BGK0/2.5

    5000 mL

    24571-108-06

    PRISMASOL BGK4/2.5

    5000 mL

    24571-105-06

    PRISMASOL BGK2/3.5

    5000 mL

    24571-103-06

    PRISMASOL BGK2/0

    5000 mL

    24571-102-06

    PRISMASOL B22GK4/0

    5000 mL

    24571-111-06

    PRISMASOL BK0/0/1.2

    5000 mL

    24571-113-06

    PRISMASOL BGK4/0/1.2

    5000 mL

    24571-114-06

    PHOXILLUM Solutions

    PHOXILLUM BK4/2.5

    5000 mL

    24571-116-06

    PHOXILLUM B22K4/0

    5000 mL

    24571-117-06

    Not all formulations may be marketed.

    Storage conditions

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]

    Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have been damaged.

    Manufactured for:
    Baxter Healthcare Corporation
    One Baxter Parkway
    Deerfield, Illinois 60015

    07-19-00-0408

    Baxter, Gambro, Phoxillum and PrismaSol are trademarks of Baxter International Inc., or its subsidiaries

  • Package/Label Display Panel

    PrismaSol Representative Container Label BGK0/2.5

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-108-06

    OK+
    mEq/L

    2.5 Ca2+
    mEq/L

    PrismaSolBGK0/2.5
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Calcium chloride • 2H2O

    3.68

    Magnesium chloride • 6H2O

    3.05

    Dextrose anhydrous

    20.0

    (as dextrose monohydrate)

    22.0

    Sodium chloride

    6.46

    Lactic acid

    5.40

    Sodium bicarbonate

    3.09

    Water for injections q.s, Carbon dioxide for pH adjustment


    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    1.25

    0.75

    140

    109.0

    3.0

    32

    0

    5.5

    mEq/L

    2.5

    1.5

    140

    109.0

    3.0

    32

    0

    (100 mg/dL)

     
    Theoretical osmolarity: 292 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414091613
    Product # 110240

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0110

    PrismaSol Representative Container Label BGK4/2.5

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-105-06

    4K+
    mEq/L

    2.5 Ca2+
    mEq/L

    PrismaSolBGK4/2.5
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Calcium chloride • 2H2O

    3.68

    Magnesium chloride • 6H2O

    3.05

    Dextrose anhydrous

    20.0

    (as dextrose monohydrate)

    22.0

    Sodium chloride

    6.46

    Potassium chloride

    0.314

    Lactic acid

    5.40

    Sodium bicarbonate

    3.09

    Water for injections q.s, Carbon dioxide for pH adjustment


    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    1.25

    0.75

    140

    113.0

    3.0

    32

    4.0

    5.5

    mEq/L

    2.5

    1.5

    140

    113.0

    3.0

    32

    4.0

    (100 mg/dL)

     
    Theoretical osmolarity: 300 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414091637
    Product # 110242

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy
    07-25-00-0112

    PrismaSol Representative Container Label BGK2/3.5

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-103-06

    2K+
    mEq/L

    3.5 Ca2+
    mEq/L

    PrismaSolBGK2/3.5
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Calcium chloride • 2H2O

    5.15

    Magnesium chloride • 6H2O

    2.03

    Dextrose anhydrous

    20.0

    (as dextrose monohydrate)

    22.0

    Sodium chloride

    6.46

    Potassium chloride

    0.157

    Lactic acid

    5.40

    Sodium bicarbonate

    3.09

    Water for injections q.s, Carbon dioxide for pH adjustment

    Rx only
    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    1.75

    0.5

    140

    111.5

    3.0

    32

    2.0

    5.5

    mEq/L

    3.5

    1.0

    140

    111.5

    3.0

    32

    2.0

    (100 mg/dL)

     
    Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414091644
    Product # 110243

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy
    07-25-00-0113

    PrismaSol Representative Container Label BGK2/0

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-102-06

    2K+
    mEq/L

    0Ca2+
    mEq/L

    PrismaSol BGK2/0
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Magnesium chloride • 6H2O

    2.03

    Dextrose anhydrous

    20.0

    (as dextrose monohydrate)

    22.0

    Sodium chloride

    6.46

    Potassium chloride

    0.157

    Lactic acid

    5.40

    Sodium bicarbonate

    3.09

    Water for injections q.s, Carbon dioxide for pH adjustment


    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    0

    0.5

    140

    108.0

    3.0

    32

    2.0

    5.5

    mEq/L

    0

    1.0

    140

    108.0

    3.0

    32

    2.0

    (100 mg/dL)

     
    Theoretical osmolarity: 291 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414091651
    Product # 110244

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0114

    PrismaSol Representative Container Label B22GK4/0

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-111-06

    4K+
    mEq/L

    Bicarbonate 22

    0Ca2+
    mEq/L

    PrismaSol B22GK4/0
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Magnesium chloride • 6H2O

    3.05

    Dextrose anhydrous

    20.0

    (as dextrose monohydrate)

    22.0

    Sodium chloride

    7.07

    Potassium chloride

    0.314

    Lactic acid

    5.40

    Sodium bicarbonate

    2.21

    Water for injections q.s, Carbon dioxide for pH adjustment


    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    0

    0.75

    140

    120.5

    3.0

    22

    4.0

    5.5

    mEq/L

    0

    1.5

    140

    120.5

    3.0

    22

    4.0

    (100 mg/dL)

     
    Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414116781
    Product # 115001

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0115

    PrismaSol Representative Container Label BK0/0/1.2

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-113-06

    0K+
    mEq/L

    0Ca2+
    mEq/L

    PrismaSol BK0/0/1.2
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Magnesium chloride • 6H2O

    2.44

    Sodium chloride

    6.46

    Lactic acid

    5.40

    Sodium bicarbonate

    3.09

    Water for injections q.s, Carbon dioxide for pH adjustment


    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    0

    0.6

    140

    106.2

    3.0

    32

    0

    0

    mEq/L

    0

    1.2

    140

    106.2

    3.0

    32

    0

    (0 mg/dL)

     
    Theoretical osmolarity: 282 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414091309
    Product # 110239

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0109

    PrismaSol Representative Container Label BGK4/0/1.2

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Barcode
    NDC# 24571-114-06

    4K+
    mEq/L

    0Ca2+
    mEq/L

    PrismaSol BGK4/0/1.2
    Rx only
    Barcode
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution each 1000 mL contains (g)

    A

    B

    Magnesium chloride • 6H2O

    2.44

    Dextrose anhydrous

    20.0

    (as dextrose monohydrate)

    22.0

    Sodium chloride

    6.46

    Potassium chloride

    0.314

    Lactic acid

    5.40

    Sodium bicarbonate

    3.09

    Water for injections q.s, Carbon dioxide for pH adjustment


    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Lactate
    C3H5O3-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Dextrose

    mmol/L

    0

    0.6

    140

    110.2

    3.0

    32

    4.0

    5.5

    mEq/L

    0

    1.2

    140

    110.2

    3.0

    32

    4.0

    (100 mg/dL)

     
    Theoretical osmolarity: 295 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and

    further instructions.

    Sterile and free from bacterial endotoxins.

    Confirm the integrity of the packaging. Use only if

    solution is clear. For single use only.

    DISCARD ANY UNUSED SOLUTION.

    Store at +20°C to +25°C (+68°F to +77°F); excursions

    permitted to +15°C to +30°C (+59°F to

    +86°F). [See USP Controlled room Temperature.]

    Do not freeze or expose to excessive heat.

    As soon as the overwrap is removed, the reconstitution

    of compartments A and B should be done

    and the reconstituted solution should be used immediately.

    After removal of the overwrap, the solution

    is stable for 24 hours including the duration of

    the treatment. Mix additives BEFORE connecting

    this bag to the extracorporeal circuit. (See insert

    for further information.) This product is not made

    with natural rubber latex.

    5000 mL
    EAN-14: 07332414091620
    Product # 110241

    Batch No. and expiry date are printed on the back of the bag.
    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0111

    Phoxillum Representative Container Label BK4/2.5

    Mixing steps
    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Compartment B

    Barcode
    NDC# 24571-116-06

    4K+
    mEq/L

    1 Phosphate
    mmol/L

    2.5 Ca2+
    mEq/L

    Phoxillum BK4/2.5
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution, each 1000 mL contains (g):

    A

    B

    Calcium chloride • 2H2O

    3.68

    Magnesium chloride • 6H2O

    3.05

    Sodium chloride

    6.34

    Potassium chloride

    0.314

    Sodium bicarbonate

    3.09

    Dibasic sodium phosphate • 2H2O

    0.187

    Water for injections q.s

    Rx only
    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Phosphate
    HPO42-

    Dextrose

    mmol/L

    1.25

    0.75

    140

    114.5

    32

    4.0

    1

    0

    mEq/L

    2.5

    1.5

    140

    114.5

    32

    4.0

    (1 mmol/L)

    (0 mg/dL)

     
    Theoretical osmolarity: 294 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.
    See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.
    Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-
    USED SOLUTION. Store at +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC - +30ºC (+59ºF
    to +86ºF). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the
    overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted
    solution should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment. Mix additives BEFORE connecting this bag to the extracorporeal circuit. (See insert for
    further information.) This product is not made with natural rubber latex. Carbon dioxide and diluted hydrochloric

    acid added for pH adjustment.

    5000 mL
    EAN-14: 07332414116040
    Product # 114905

    Batch No. and expiry date are printed on the
    back of the bag.

    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0107

    Phoxillum Representative Container Label B22K4/0

    Mixing steps

    ① SQUEEZE TOP corners to break seal

    Squeeze BAG SIDES to fully open seal

    Compartment B

    Barcode
    NDC# 24571-117-06

    4K+
    mEq/L

    0 Ca2+
    mEq/L

    22 Bicarbonate
    mEq/L

    1 Phosphate
    mmol/L

    Phoxillum B22K4/0
    Replacement Solution for Continuous Renal Replacement Therapy

    Before reconstitution, each 1000 mL contains (g):

    A

    B

    Magnesium chloride • 6H2O

    3.05

    Sodium chloride

    6.95

    Potassium chloride

    0.314

    Sodium bicarbonate

    2.21

    Dibasic sodium phosphate • 2H2O

    0.187

    Water for injections q.s

    Rx only
    A
    250 mL

    B
    4750 mL

    After reconstitution, A + B

    Calcium
    Ca2+

    Magnesium
    Mg2+

    Sodium
    Na+

    Chloride
    Cl-

    Bicarbonate
    HCO3-

    Potassium
    K+

    Phosphate
    HPO42-

    Dextrose

    mmol/L

    0

    0.75

    140

    122.0

    22

    4.0

    1

    0

    mEq/L

    0

    1.5

    140

    122.0

    22

    4.0

    (1 mmol/L)

    (0 mg/dL)

     
    Theoretical osmolarity: 290 mOsm/L pH: 7.0 – 8.5

    Mix both compartments before use.

    See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.
    Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-
    USED SOLUTION. Store at +20°C to +25°C (+68°F to +77°F); excursions permitted to +15°C to +30°C (+59°F
    to +86°F). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the
    overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solution
    should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration
    of the treatment. Mix additives BEFORE connecting this bag to the extracorporeal circuit. (See insert for
    further information.) This product is not made with natural rubber latex. Carbon dioxide and diluted hydrochloric
    acid added for pH adjustment.

    5000 mL
    EAN-14: 07332414116057
    Product # 114906

    Batch No. and expiry date are printed on the
    back of the bag.

    Manufactured for:
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA
    Made in Italy

    GAMBRO Logo

    REPLACEMENT
    Solution for Continuous Renal Replacement Therapy

    07-25-00-0108

  • INGREDIENTS AND APPEARANCE
    PRISMASOL  BGK0/2.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-108
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE3.68 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE3.05 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE22 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.46 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-108-062 in 1 CASE10/25/2006
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PRISMASOL  BGK4/2.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-105
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE3.68 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE3.05 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE22 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.46 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.314 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-105-062 in 1 CASE10/25/2006
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PRISMASOL  BGK2/3.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-103
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE5.15 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE2.03 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE22 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.46 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.157 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-103-062 in 1 CASE10/25/2006
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PRISMASOL  BGK2/0
    magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-102
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE2.03 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE22 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.46 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.157 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-102-062 in 1 CASE10/25/2006
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PRISMASOL  B22GK4/0
    magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-111
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE3.05 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE22 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE7.07 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2.21 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.314 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-111-062 in 1 CASE10/10/2008
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PRISMASOL  BK0/0/1.2
    magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-113
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE2.44 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.46 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-113-062 in 1 CASE10/10/2008
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PRISMASOL  BGK4/0/1.2
    magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-114
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE2.44 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE22 g  in 1 L
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM5.4 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.46 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.314 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-114-062 in 1 CASE10/10/2008
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170310/25/2006
    PHOXILLUM  BK4/2.5
    calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-116
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE3.68 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE3.05 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.34 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE3.09 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.314 g  in 1 L
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE0.187 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-116-062 in 1 CASE01/13/2015
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20702601/13/2015
    PHOXILLUM  B22K4/0
    magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24571-117
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE3.05 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.95 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2.21 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.314 g  in 1 L
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE0.187 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24571-117-062 in 1 CASE01/13/2015
    15 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20702601/13/2015
    Labeler - Baxter Healthcare Corporation (005083209)
    Registrant - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter, S.A. de C.V.810432484ANALYSIS(24571-108, 24571-105, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , LABEL(24571-108, 24571-105, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , MANUFACTURE(24571-108, 24571-105, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , PACK(24571-108, 24571-105, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , STERILIZE(24571-108, 24571-105, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117)