PRISMASOL BGK0/2.5

PRISMASOL BGK0/2.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, l-, sodium chloride and sodium bicarbonate solution
PRISMASOL BGK4/2.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, l-, sodium chloride, sodium bicarbonate and potassium chloride solution
PRISMASOL BGK4/3.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, l-, sodium chloride, sodium bicarbonate and potassium chloride solution
PRISMASOL BGK2/3.5- calcium chloride, magnesium chloride, dextrose monohydrate, sodium chloride, lactic acid, l-, sodium bicarbonate and potassium chloride solution
PRISMASOL BGK2/0- magnesium chloride, dextrose monohydrate, lactic acid, l-, sodium chloride, sodium bicarbonate and potassium chloride solution
PRISMASOL B22GK4/0- magnesium chloride, dextrose monohydrate, lactic acid, l-, sodium chloride, sodium bicarbonate and potassium chloride solution
PRISMASOL BK0/0/1.2- magnesium chloride, lactic acid, l-, sodium chloride and sodium bicarbonate solution
PRISMASOL BGK4/0/1.2- magnesium chloride, dextrose monohydrate, lactic acid, l-, 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
Baxter Healthcare Corporation

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 (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 HPO4 2- mmol/L Cl- mEq/L Lactate mEq/L Dextrose mg/dL Osmolarity mOsm/L
Ca2+ = calcium, HCO3 - = bicarbonate, K+ = potassium, Mg2+ = magnesium, Na+ = sodium, HPO4 2- = 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.
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