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

  • NDC Code(s): 24571-102-05, 24571-102-06, 24571-103-05, 24571-103-06, view more
    24571-104-05, 24571-105-05, 24571-105-06, 24571-108-05, 24571-108-06, 24571-111-05, 24571-111-06, 24571-113-05, 24571-113-06, 24571-114-05, 24571-114-06, 24571-116-05, 24571-117-05
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 1, 2016

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

    RECENT MAJOR CHANGES

    Dosage and Administration (2.2, 2.3)
    Contraindications

    12/2015

    07/2016

    Warnings and Precautions (5.1)

    07/2016

    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)
    Antidiabetic therapy may need adjustment during treatment with dextrose containing formulations ( 5.2)

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

    Revised: 12/2016

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  • FULL PRESCRIBING INFORMATION: 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.

    Close
  • 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 (8 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 10 different replacement solutions (total volume is 5 Liters).

    Table 1: Concentrations of Active Ingredients in the 8 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

    BGK4/3.5

    3.5

    32

    4

    1

    140

    0

    113.5

    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, frangible pin or peel seal is not broken, and the solution is clear.

    The solution may be warmed to 37°C/98.6°F inside of 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, one made of polyvinyl chloride with a frangible pin separating compartment A and B (see Figure 1) and one made of polyolefin with a peel seal separating compartment A and B (see Figure 6).

    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, polyvinyl chloride (PVC) bag with a red frangible pin:

    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 container 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.
    Open the seal by breaking the red frangible pin between the two compartments of the bag. The frangible pin will remain in the bag. (See Figure 2 beside)

    Figure 3 Figure 3

    Step 2 Make sure all the fluid from the small compartment A is transferred into the large compartment B. (See Figure 3 beside)

    Step 3 Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back into the large compartment B. (See Figure 3 beside)

    Figure 4Figure 4

    Step 4 When the small compartment A is empty, shake the large compartment B so that the contents mix completely. (See Figure 4 beside)
    The solution is now ready to use and the bag can be hung on the equipment.

    Figure 5aFigure 5a

    Step 5 The replacement line may be connected to the bag through either the luer connector or the injection connector (spike connector).
    Step 5a 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 5a 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 5bFigure 5b

    Step 5b 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 5b beside)
    Ensure that the spike is fully inserted and verify that the fluid is flowing freely during use.

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

    Figure 6

    Figure 7

    Figure 7Figure 7

    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 container 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 7 beside)

    Figure 8Figure 8

    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 8 beside)

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

    Figure 9aFigure 9

    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 9a 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 9bFigure 9b

    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 9b 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, drugs other than phosphate should be administered through a different access line.

    When introducing drugs, use aseptic techniques and mix thoroughly. Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

    PRISMASOL Solutions:

    Phosphate: Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 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.

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  • 3 DOSAGE FORMS AND STRENGTHS

    See Table 1 for the concentrations of the active ingredients (after mixing) in these 10 different replacement solutions [see Dosage and Administration (2.2)].

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  • 4 CONTRAINDICATIONS

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

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  • 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, 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 Hyperglycemia with Dextrose Containing Solutions

    The use of PRISMASOL replacement solutions containing dextrose may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation of or modification of antidiabetic therapy during treatment with PRISMASOL solutions containing dextrose. Monitor blood glucose.

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  • 6 ADVERSE REACTIONS

    The following adverse reactions have been identified with other similar products and therefore, may occur with use of these products:

    Metabolic acidosis
    Hypotension
    Acid-base disorders
    Electrolyte imbalance
    Hyperphosphatemia (for phosphate containing solutions)
    Fluid imbalance
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  • 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.

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  • 8 USE IN SPECIFIC POPULATION

    8.1 Pregnancy

    Pregnancy Category C

    Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM 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, or affect reproductive capacity. Maintenance of normal acid-base balance is important for fetal well-being.

    8.3 Nursing Mothers

    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.

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  • 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 ∙ 2H2O Magnesium Chloride ∙ 6H2O Dextrose anhydrous (as monohydrate) Lactic Acid Sodium Chloride Sodium bicarbonate Potassium Chloride Sodium 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 4/3.5

    5.15

    2.03

    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.

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  • 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.

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  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of either polyvinyl chloride (PVC) or 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 red frangible pin in the PVC bag and by a peel seal in the polyolefin bag.

    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

    Bag Type

    PRISMASOL Solutions

    PRISMASOL BGK0/2.5

    5000 mL

    24571-108-05

    PVC

    PRISMASOL BGK4/2.5

    5000 mL

    24571-105-05

    PRISMASOL BGK4/3.5

    5000 mL

    24571-104-05

    PRISMASOL BGK2/3.5

    5000 mL

    24571-103-05

    PRISMASOL BGK2/0

    5000 mL

    24571-102-05

    PRISMASOL B22GK4/0

    5000 mL

    24571-111-05

    PRISMASOL BK0/0/1.2

    5000 mL

    24571-113-05

    PRISMASOL BGK4/0/1.2

    5000 mL

    24571-114-05

    PRISMASOL BGK0/2.5

    5000 mL

    24571-108-06

    Polyolefin

    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

    24571-116-05

    PVC

    PHOXILLUM B22K4/0

    5000 mL

    24571-117-05

    PHOXILLUM BK4/2.5

    5000 mL

    24571-116-06

    Polyolefin

    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

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

    Close
  • Package/Label Display Panel

    PrismaSol Representative Container Label BGK0/2.5   1 of 2
    PrismaSol Representative Container Label BGK0/2.5   2 of 2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-108-06

    0K+
    mEq/L

    2.5 Ca2+
    mEq/L

    Rx only

    PrismaSol® BGK0/2.5
    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

    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.


    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414091613 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000293 2015-10

    PrismaSol Representative Carton Label BGK0/2.5

    Carton Label

    PrismaSol BGK0/2.5
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 110240 S
    NDC# 24571-108-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000293 Rev. 2016-04

    PrismaSol Representative Container Label BGK4/2.5  1 of 2
    PrismaSol Representative Container Label BGK4/2.5  2 of 2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-105-06

    4K+
    mEq/L

    2.5 Ca2+
    mEq/L

    Rx only

    PrismaSol® BGK4/2.5
    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

    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

    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.

    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414091637 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000295 2015-10

    PrismaSol Representative Carton Label BGK4/2.5

    Carton Label

    PrismaSol BGK4/2.5
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 110242 S
    NDC# 24571-105-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000295 Rev. 2016-04

    PrismaSol Representative Container BGK4/3.5  1 of 2
    PrismaSol Representative Container BGK4/3.5  2 of 2

    Container Label

    ! Symbol BREAK red pin and MIX
    compartment A with compartment B Compartment A Symbol

    D14000299 Rev. 2015-09

    Break red pin and mix. ↑ Symbol Compartment B Symbol

    4K+
    mEq/L

    3.5 Ca2+
    mEq/L

    PrismaSol® BGK4/3.5
    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

    0.314

    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

    113.5

    3.0

    32

    4.0

    5.5

    mEq/L

    3.5

    1.0

    140

    113.5

    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 +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +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 du-
    ration of the treatment. (See insert for further information.) This product is not made with natural rubber latex.


    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414120160 Product# 115633

    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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000306 Rev. 2015-09

    PrismaSol Representative Carton Label BGK4_3.5

    Carton Label

    PrismaSol BGK4/3.5
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 1105633
    NDC# 24571-104-05

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000306 Rev. 2015-09

    PrismaSol Representative Container Label BGK2/3.5  1 of 2
    PrismaSol Representative Container Label BGK2/3.5  2 of 2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-103-06

    2K+
    mEq/L

    3.5 Ca2+
    mEq/L

    Rx only

    PrismaSol® BGK2/3.5
    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


    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.

    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414091644 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000296 2015-10

    PrismaSol Representative Carton Label BGK2/3.5

    Carton Label

    PrismaSol BGK2/3.5
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 110243 S
    NDC# 24571-103-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000296 Rev. 2016-04

    PrismaSol Representative Container Label BGK2/0 1 of 2
    PrismaSol Representative Container Label BGK2/0 2 of 2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-102-06

    2K+
    mEq/L

    0Ca2+
    mEq/L

    Rx only

    PrismaSol® BGK4/3.5
    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


    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

    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.

    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414091651 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000297 2015-10

    PrismaSol Representative Carton Label BGK2/0

    Carton Label


    PrismaSol BGK2/0
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 110244 S
    NDC# 24571-102-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000297 Rev. 2016-04

    PrismaSol Representative Container Label B22GK4/0  1 of 2
    PrismaSol Representative Container Label B22GK4/0  2 of 2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-111-06

    4K+
    mEq/L

    Bicarbonate 22

    0Ca2+
    mEq/L

    Rx only

    PrismaSol®B22GK4/0
    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.

    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414116781 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000298 2015-10

    PrismaSol Representative Carton Label B22GK4/0

    Carton Label

    PrismaSol B22GK4/0
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 115001 S
    NDC# 24571-111-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000298 Rev. 2016-04

    PrismaSol Representative Container Label BK0/0/1.2   1 of 2
    PrismaSol Representative Container Label BK0/0/1.2   2 of 2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-113-06

    0K+
    mEq/L

    0Ca2+
    mEq/L

    Rx only

    PrismaSol® BK0/0/1.2
    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.

    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414091309 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000292 2015-09

    PrismaSol Representative Carton Label BK0/0/1.2

    Carton Label

    PrismaSol BK0/0/1.2
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 110239 S
    NDC# 24571-113-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000292 Rev. 2016-04

    PrismaSol Representative Container Label BGK4/0/1.2   1 of  2
    PrismaSol Representative Container Label BGK4/0/1.2   2 of  2

    Container Label

    ! Symbol MIX Compartments ! Symbol
    D14000292 Ver. 1.0

    Mixing steps:
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Bar Code
    NDC# 24571-114-06

    4K+
    mEq/L

    0Ca2+
    mEq/L

    Rx only

    PrismaSol® BGK4/0/1.2
    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 +20ºC to +25ºC (68ºF to 77ºF); ex-
    cursions permitted to +15ºC to +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 recon-
    stitution of compartments A and B should be done
    and the reconstituted solution should be used im-
    mediately. After removal of the overwrap, the solu-
    tion is stable for 24 hours including the duration of
    the treatment. (See insert for further information.)
    This product is not made with natural rubber latex.


    5000 mL

    Gambro Logo
    GAMBRO®

    EAN-14: 07332414091620 Product No: 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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000294 2015-10

    PrismaSol Representative Carton Label BGK4/0/1.2

    Carton Label

    PrismaSol BK4/0/1.2
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 110241 S
    NDC# 24571-114-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000294 Rev. 2016-04

    Phoxillum Representative Container Label BK4/2.5  1 of 2
    Phoxillum Representative Container Label BK4/2.5  2 of 2

    Container Label

    ! Symbol MIX compartment A with compartment B Compartment A Symbol

    D14000349 Ver. 1.0

    Mixing steps
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Compartment B Symbol

    Bar Code
    NDC# 24571-116-06

    4 K+
    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 to +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 solu-
    tion should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the
    duration of the treatment. (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

    Gambro Logo
    GAMBRO®

    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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000349 Ver. 1.0

    Phoxillum Representative Carton Label BK4/2.5

    Carton Label

    Phoxillum BK4/2.5
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 114905
    NDC 24571-116-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000349 Ver. 1.0

    Phoxillum Representative Container Label B22K4/0   1 of 2
    Phoxillum Representative Container Label B22K4/0   2 of 2

    Container Label

    ! Symbol MIXcompartment A with compartment B Compartment A Symbol

    D14000349 Ver. 1.0

    Mixing steps
    1 SQUEEZE TOP corners to break seal
    2 Squeeze BAG SIDES to fully open seal

    Compartment B Symbol

    Bar Code
    NDC# 24571-117-06

    4 K+
    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 +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +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 solu-
    tion should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the
    duration of the treatment. (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

    Gambro Logo
    GAMBRO®

    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

    R E P L A C E M E N T
    Solution for Continuous Renal Replacement Therapy

    D11000350 Ver. 1.0

    Phoxillum Representative Carton Label B22K4/0

    Carton Label

    Phoxillum B22K4/0
    Replacement Solution for Continuous Renal Replacement Therapy

    REF Cat. # 114906
    NDC 24571-117-06

    LOT # Expiry

    Rx Only
    2 x 5000 mL

    Store at +20ºC top +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC to +30ºC (+59ºF to +86ºF).
    [See USP Controlled Temperature]. Do not freeze or expose to excessive heat.

    D12000350 Ver. 1.0

    Close
  • INGREDIENTS AND APPEARANCE
    PRISMASOL  BGK0/2.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-108
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.184 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.153 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-108-05 2 in 1 CASE 10/25/2006
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-108-06 2 in 1 CASE 10/25/2006
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  BGK4/2.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride sodium bicarbonate, and potassium chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-105
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.184 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.153 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.298 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-105-05 2 in 1 CASE 10/25/2006
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-105-06 2 in 1 CASE 10/25/2006
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  BGK4/3.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-104
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.257 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.102 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.298 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-104-05 2 in 1 CASE 10/25/2006
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  BGK2/3.5
    calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-103
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.257 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.102 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.149 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-103-05 2 in 1 CASE 10/25/2006
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-103-06 2 in 1 CASE 10/25/2006
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  BGK2/0
    magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-102
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.102 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.149 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-102-05 2 in 1 CASE 10/25/2006
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-102-06 2 in 1 CASE 10/25/2006
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  B22GK4/0
    magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-111
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.153 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.721 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1.848 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.298 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-111-05 2 in 1 CASE 10/10/2008
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-111-06 2 in 1 CASE 10/10/2008
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  BK0/0/1.2
    magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-113
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.122 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-113-05 2 in 1 CASE 10/10/2008
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-113-06 2 in 1 CASE 10/10/2008
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PRISMASOL  BGK4/0/1.2
    magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-114
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.122 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.10 g  in 1 L
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 0.270 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.136 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.298 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-114-05 2 in 1 CASE 10/10/2008
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    2 NDC:24571-114-06 2 in 1 CASE 10/10/2008
    2 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021703 10/25/2006
    PHOXILLUM  BK4/2.5
    calcium chloride, magnesium chloride, sodium chloride, potassium chloride, sodium phosphate dibasic dihydrate, and sodium bicarbonate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-116
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.184 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.153 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.019 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.298 g  in 1 L
    SODIUM PHOSPHATE, DIBASIC DIHYDRATE (UNII: 94255I6E2T) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC DIHYDRATE 0.178 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 2.688 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-116-05 2 in 1 CASE 01/13/2015
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA207026 01/13/2015
    PHOXILLUM  B22K4/0
    magnesium chloride, sodium chloride, potassium chloride, sodium phosphate dibasic dihydrate and sodium bicarbonate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-117
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.153 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.603 g  in 1 L
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 0.298 g  in 1 L
    SODIUM PHOSPHATE, DIBASIC DIHYDRATE (UNII: 94255I6E2T) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC DIHYDRATE 0.178 g  in 1 L
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1.848 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24571-117-05 2 in 1 CASE 01/13/2015
    1 5 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA207026 01/13/2015
    Labeler - Baxter Healthcare Corporation (005083209)
    Registrant - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Gambro Renal Products Inc. 040047519 ANALYSIS(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , MANUFACTURE(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , LABEL(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , PACK(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , STERILIZE(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117)
    Establishment
    Name Address ID/FEI Business Operations
    Bieffe Medital S.p.A. 437668413 ANALYSIS(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , LABEL(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , MANUFACTURE(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , PACK(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117) , STERILIZE(24571-108, 24571-105, 24571-104, 24571-103, 24571-102, 24571-111, 24571-113, 24571-114, 24571-116, 24571-117)
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