Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A)
General Injectables & Vaccines, Inc
Heparin Sodium
Heparin Sodium 10000 [USP'U] in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Heparin sodium is indicated for: Atrial fibrillation with embolization: Diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and heart surgery; Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; (In a low-dose regimen) for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION); Prophylaxis and treatment of pulmonary embolism; Prophylaxis and treatment of peripheral arterial embolism. Heparin sodium should not be used in patients: With severe thrombocytopenia; In whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc. — cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no ne
New Drug Application
HEPARIN SODIUM - HEPARIN SODIUM INJECTION, SOLUTION, CONCENTRATE GENERAL INJECTABLES & VACCINES, INC ---------- HEPARIN SODIUM ADD-VANTAGE VIAL 10000 UN INJECTION, USP 5ML SINGLE DOSE VIAL DES CRIPTION Heparin Sodium Injection, USP is a sterile, nonpyrogenic solution of heparin sodium (derived from porcine intestinal mucosa) in water for injection. Each container contains 10000, 12500, 20000 or 25,000 USP Heparin Units; 40 or 80 mg sodium chloride added to render isotonic (see HOW SUPPLIED section for various sizes and strength). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.0 (5.0 to 7.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. Heparin sodium in the ADD- Vantage® system is intended for intravenous administration only after dilution. 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) a- L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-a-D-glucose-6-sulfate, (3) b-D- glucuronic acid, (4) 2-acetamido-2-deoxy-a-D-glucose, and (5) a-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) greater than (1)greater than (4) greater than (3) greater than (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 is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits): CLINICAL PHARMACOLOGY Heparin inhibits reactions that lead to the clotting of blood and the formation of f Διαβάστε το πλήρες έγγραφο