HEPARIN SODIUM IN DEXTROSE injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)

Available from:

Baxter Healthcare Corporation

INN (International Name):

HEPARIN SODIUM

Composition:

HEPARIN SODIUM 10000 [USP'U] in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM IN DEXTROSE- HEPARIN SODIUM INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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HEPARIN SODIUM IN 5% DEXTROSE INJECTION
IN PLASTIC CONTAINER VIAFLEX PLUS CONTAINER (PL 146 PLASTIC)
DESCRIPTION
Heparin Sodium in 5% Dextrose Injection is a buffered, sterile,
nonpyrogenic solution of Heparin
Sodium, USP, derived from porcine intestinal mucosa, standardized for
anticoagulant activity, and
dextrose in water for injection. Heparin Sodium, USP, is a
heterogenous group of straight-chain anionic
mucopolysaccharides, called glycosaminoglycans having anticoagulant
properties. Although others
may be present, the main sugars occurring in heparin are: (1)
α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-
sulfamino-α-D-glucose 6-sulfate, (3) ß-D-glucuronic acid, (4)
2-acetamido-2-deoxy-α-D-glucose, and
(5) α-L-iduronic acid. These sugars are present in decreasing
amounts, usually in the order (2) > (1) >
(4) > (3) > (5), and are joined by glycosidic linkages, forming
polymers of varying sizes. Heparin is
strongly acidic because of its content of covalently linked sulfate
and carboxylic acid groups. In heparin
sodium, the acidic protons of the sulfate units are partially replaced
by sodium ions. The potency of the
heparin is determined by biological assay using USP reference standard
based upon units of heparin
activity per milligram.
STRUCTURE OF HEPARIN SODIUM (REPRESENTATIVE SUBUNITS):
Dextrose Hydrous, USP, is chemically designated D-gluco pyranose
monohydrate, a hexose sugar
freely soluble in water. It has the following structural formula:
The solution is intended for intravenous use only. It contains no
antimicrobial agents or bacteriostatic
agents.
Each 100 mL contains 4,000 or 5,000 or 10,000 USP Heparin Units
Heparin Sodium, USP with 5 g
Dextrose Hydrous, USP, 103 mg Dibasic Sodium Phosphate Dried, USP (Na
HPO ) and 51 mg Citric
Acid Anhydrous, USP (C H O ) added as buffers. 20 mg sodium bisulfite
is added as a stabilizer. pH
5.5 (5.0 - 6.0). pH may have been adjusted with citric acid and/or
sodiu