HEPARIN SODIUM- heparin sodium injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Safecor Health, LLC

Designación común internacional (DCI):

HEPARIN SODIUM

Composición:

HEPARIN 5000 [USP'U] in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Heparin Sodium Injection, USP is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION ); Prophylaxis and treatment of pulmonary embolism; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures. Heparin sodium should NOT be used in patients with the following conditions: Severe thrombocytopenia; When suitable blood coagulation tests, e.g., the whole b

Resumen del producto:

Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: 48433-329-01 5,000 USP Heparin Units/mL 1 mL Multiple Dose Vial 100 Unit Dose Overwrap Bags per Box NDC Number Concentration Vial Fill Volume Vial Type Pack Size 48433-330-01 10,000 USP Heparin Units/mL 1 mL Multiple Dose Vial 100 Unit Dose Overwrap Bags per Box Overwrap Packaged and Distributed by: Questions or Comments? Call 1-800-447-1006 Sterile, Nonpyrogenic Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made from natural rubber latex. STORAGE   Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
SAFECOR HEALTH, LLC
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HEPARIN SODIUM INJECTION, USP
R ONLY
DERIVED FROM PORCINE INTESTINAL MUCOSA.
Contains Parabens
DESCRIPTION
Heparin is a heterogeneous 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) _β_-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.
Heparin Sodium Injection, USP is a sterile solution of heparin sodium
derived from porcine intestinal
mucosa, standardized for anticoagulant activity, in water for
injection. It is to be administered by
intravenous or deep subcutaneous routes. 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):
Heparin Sodium Injection, USP (porcine), preserved with parabens, is
available as follows:
Each mL of the 5,000 units per mL preparation contains: 5,000 USP
Heparin units (porcine); 5 mg
sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water
for Injection q.s. Hydrochloric
X
acid and/or sodium hydroxide may have been added for pH adjustment
(5.0-7.5).
Each mL of the 10,000 units per mL preparation contains: 10,000 USP
Heparin units (porcine); 1.5 mg
methylparaben; 0.15 mg propylparaben; Water for Injection q.s.
Hydrochloric acid and/or sodium
hydroxide may have been added for pH adjustment (5.0-7.5).
CLINICAL PHARMACOLOGY
Heparin inhibits