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 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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

Baxter Healthcare Corporation

INN (International Name):

CALCIUM CHLORIDE

Composition:

CALCIUM CHLORIDE 0.184 g in 1 L

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products. 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. Maintenance of normal acid-base balance is important for fetal well-being. 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. 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. The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

Product summary:

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 07-19-00-6103 Baxter, Gambro, Phoxillum and PrismaSol are trademarks of Baxter International Inc., or its subsidiaries

Authorization status:

New Drug Application

Summary of Product characteristics

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 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
BAXTER HEALTHCARE CORPORATION
REFERENCE LABEL SET ID: 25C4D41F-BDCC-479E-A49F-96D7A2D46FC1
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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:
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
PRISMASOL and PHOXILLUM are available in multiple combinations of
ingredients and in multiple variations
of strengths. See full Prescri