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 BGK4/3.5- 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

PHOXILLUM by

Drug Labeling and Warnings

PHOXILLUM by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• 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

  FULL PRESCRIBING INFORMATION: CONTENTS*

  1 INDICATIONS AND USAGE

  2 DOSAGE AND ADMINISTRATION

  2.1 Administration Instructions

  2.2 Dosing Considerations

  2.3 Preparing the Solution

  2.4 Adding Drugs to the Solutions

  3 DOSAGE FORMS AND STRENGTHS

  4 CONTRAINDICATIONS

  5 WARNINGS AND PRECAUTIONS

  5.1 Electrolyte and Volume Abnormalities

  5.2 Blood Glucose Abnormalities

  6 ADVERSE REACTIONS

  7 DRUG INTERACTIONS

  7.1 Citrate

  8 USE IN SPECIFIC POPULATIONS

  8.1 Pregnancy

  8.2 Lactation

  8.4 Pediatric Use

  8.5 Geriatric Use

  11 DESCRIPTION

  12 CLINICAL PHARMACOLOGY

  12.1 Mechanism of Action

  12.3 Pharmacokinetics

  16 HOW SUPPLIED/STORAGE AND HANDLING

  * Sections or subsections omitted from the full prescribing information are not listed.

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 ).

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 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 beside)

• 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 beside)

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

• Figure 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 a 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:

  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 b 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 ∙ 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 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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

Mixing steps

① SQUEEZE TOP corners to break seal

② Squeeze BAG SIDES to fully open seal

Barcode
NDC# 24571-105-06

4K+
mEq/L

2.5 Ca2+
mEq/L

PrismaSolBGK4/2
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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

Mixing steps
① SQUEEZE TOP corners to break seal

② 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

Mixing steps

① SQUEEZE TOP corners to break seal

② 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

! Symbol
BREAK red pin and MIX
Compartment A Symbol
D07900004 Rev. 2012-08/1

Break red pin and mix.

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 15º-30ºC (59º-86ºF). [See USP Controlled
Room Temperature]. Do not freeze or expose to excessive heat. As soon as the overwrap is removed, the reconsti-
tution 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. (See insert for
further information.) This product is latex free.

5000 mL
EAN-14: 07332414120160
Product # 115633

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

Manufactured by:
Gambro Renal Products, Inc.
1845 Mason Avenue, Daytona Beach FL 32117, USA

GAMBRO Logo

D07200052 Rev 2013-11

REPLACEMENT
Solution for Continuous Renal Replacement Therapy

INGREDIENTS AND APPEARANCE

PRISMASOL  BGK0/2.5
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate injection

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	3.68 g  in 1 L
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	3.05 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 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	12/31/2017
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 injection

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	3.68 g  in 1 L
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	3.05 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.314 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	12/31/2017
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 injection

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	5.15 g  in 1 L
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	2.03 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.314 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	12/31/2017
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	12/31/2017

PRISMASOL  BGK2/3.5
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride injection

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	5.15 g  in 1 L
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	2.03 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.157 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	12/31/2017
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 injection

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	2.03 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.157 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	12/31/2017
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 injection

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	3.05 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	7.07 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	2.21 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.314 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	12/31/2017
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 injection

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	2.44 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 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	12/31/2017
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 injection

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	2.44 g  in 1 L
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	22 g  in 1 L
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	5.4 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.46 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.314 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	12/31/2017
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, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate injection

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	3.68 g  in 1 L
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	3.05 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.34 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	3.09 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.314 g  in 1 L
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	0.187 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	12/31/2017
1		5 L in 1 BAG; Type 0: Not a Combination Product
2	NDC: 24571-116-06	2 in 1 CASE	01/13/2015
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	NDA207026	01/13/2015

PHOXILLUM  B22K4/0
magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate injection

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	3.05 g  in 1 L
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.95 g  in 1 L
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	2.21 g  in 1 L
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	0.314 g  in 1 L
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	0.187 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	12/31/2017
1		5 L in 1 BAG; Type 0: Not a Combination Product
2	NDC: 24571-117-06	2 in 1 CASE	01/13/2015
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	NDA207026	01/13/2015

Labeler - Baxter Healthcare Corporation (005083209)

Registrant - Baxter Healthcare Corporation (005083209)

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)