PRISMASOL Renal replacement solution Ref.[50589] Active ingredients: Calcium chloride Glucose Lactic acid Magnesium chloride Potassium chloride Sodium bicarbonate Sodium chloride

Source: FDA, National Drug Code (US) Revision Year: 2022

Product 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.

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)].

How Supplied

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.

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

Drugs

Drug	Countries
PRISMASOL	Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Malta, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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