Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)
Baxter Healthcare Corporation
HEPARIN SODIUM
HEPARIN SODIUM 10000 [USP'U] in 100 mL
PRESCRIPTION DRUG
New Drug Application
HEPARIN SODIUM IN DEXTROSE- HEPARIN SODIUM INJECTION, SOLUTION BAXTER HEALTHCARE CORPORATION ---------- 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 Διαβάστε το πλήρες έγγραφο