PrismaSol Solution

DRUG DESCRIPTION

PrismaSol solution (sterile hemofiltration hemodiafiltration solution) is a clear, sterile solution free of bacterial endotoxins.
This solution is used in Continuous Renal Replacement Therapies (CRRT) as a
replacement solution in hemofiltration and hemodiafiltration.

It contains no bacteriostatic or antimicrobial agents.

PrismaSol solution (sterile hemofiltration hemodiafiltration solution) is packaged in a two-compartment bag. The small compartment
A contains electrolytes and the large compartment B contains buffer. The final
reconstituted solution (5000 mL) is obtained after breaking the red frangible
pin between compartments A and B and mixing both solutions. The compositions
of the solution before and after reconstitution are described in the following
tables.

BEFORE RECONSTITUTION

1000 mL of electrolyte solution (small compartment A) contains
(g)

	PrismaSol BGK 4/2.5	PrismaSol BGK 2/3.5	PrismaSol BGK 0/2.5	PrismaSol B22GK 4/2.5
Calcium chloride•2H2O	3.68	5.15	3.68	3.68
Magnesium chloride•6H2O	3.05	2.03	3.05	3.05
Dextrose anhydrous	20.0	20.0	20.0	20.0
(as dextrose monohydrate)	22.0	22.0	22.0	22.0
Lactic acid	5.40	5.40	5.40	5.40

1000mL of buffer solution (large compartment B) contains
(g)

	PrismaSol BGK 4/2.5	PrismaSol BGK 2/3.5	PrismaSol BGK 0/2.5	PrismaSol B22GK 4/2.5
Sodium chloride	6.46	6.46	6.46	7 .07
Sodium bicarbonate	3.09	3.09	3.09	2.21
Potassium chloride	0.314	0.157	0	0.314

1000 mL of electrolyte solution (small compartment A) contains
(g)

	PrismaSol BGK4/0/1.2	PrismaSol BGK 2/0	PrismaSol B22GK4/0	PrismaSol B22GK 2/0	PrismaSol BK 0/0/1.2	PrismaSol BK 0/3.5
Calcium chloride•2H2O	0	0	0	0	0	5.15
Magnesium chloride•6H2O	2.44	2.03	3.05	3.05	2.44	2.03
Dextrose anhydrous	20.0	20.0	20.0	20.0	0	0
(as dextrose monohydrate)	22.0	22.0	22.0	22.0	0	0
Lactic acid	5.40	5.40	5.40	5.40	5.40	5.40

1000 mL of buffer solution (large compartment B) contains
(g)

	PrismaSol BGK4/0/1.2	PrismaSol BGK 2/0	PrismaSol B22GK 4/0	PrismaSol B22GK 2/0	PrismaSol BK 0/0/1.2	PrismaSol BK 0/3.5
Sodium chloride	6.46	6.46	7.07	7.07	6.46	6.46
Sodium bicarbonate	3.09	3.09	2.21	2.21	3.09	3.09
Potassium chloride	0.314	0.157	0.314	0.157	0	0

AFTER RECONSTITUTION of compartments A and B

1000 mL of the reconstituted solution contains

in mEq/L except where noted	PrismaSol BGK 4/2.5	PrismaSol BGK 2/3.5	PrismaSol BGK 0/2.5	PrismaSol B22GK 4/2.5
CalciumCa2+	2.5	3.5	2.5	2.5
Bicarbonate HCO3	32	32	32	22
Potassium K+	4.0	2.0	0	4.0
Magnesium Mg2+	1.5	1.0	1.5	1.5
Sodium Na+	140	140	140	1140
Chloride Cl	113	111.5	109	123
Lactate	3.0	3.0	3.0	3.0
Dextrose	100 mg/dL	100 mg/dL	100 mg/dL	100 mg/dL
Theoretical	300 mOsm/L	296 mOsm/L	292 mOsm/L	300 mOsm/L

in mEq/L except where noted	PrismaSol BGK 4/0/1.2	PrismaSol BGK 2/0	PrismaSol B22GK 4/0	PrismaSol B22GK 2/0
Calcium Ca2+	0	0	0	0
Bicarbonate HCO3	32	32	22	22
Potassium K+	4.0	2.0	4.0	2.0
Magnesium Mg2+	1.2	1.0	1.5	1.5
Sodium Na+	140	140	140	140
Chloride Cl	110.2	108	120.5	118.5
Lactate	3.0	3.0	3.0	3.0
Dextrose	100 mg/dL	100 mg/dL	100 mg/dL	100 mg/dL
Theoretical Osmolarity	295 mOsm/L	295 mOsm/L	295 mOsm/L	295 mOsm/L

In mEq/L except where noted	PrismaSol BK 0/0/1.2	PrismaSol BK 0/3.5
Calcium Ca2+	0	3.5
Bicarbonate HCO3	32	32
Potassium K+	0	0
Magnesium Mg2+	1.2	1.0
Sodium Na+	140	140
Chloride Cl	,106.2	109.5
Lactate	3.0	3.0
Dextrose	0	0
Theoretical Osmolarity	282 mOsm/L	287 mOsm/L

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

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

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

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

Sodium chloride, USP, is chemically designated NaCl.

Potassium chloride, USP, is chemically designated KCl.

Sodium bicarbonate, USP, is chemically designated NaHCO₃.

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

Solutions in contact with the plastic container can leach out certain of its
chemical components in very small amounts within the expiration period, e.g.
di 2-ethylhexyl phthalate (DEHP), up to 3 parts per milion; however, the safety
of the plastic has been confirmed in tests in animals according to USP biological
tests for plastic containers as well as by in-vitro toxicity studies.