HEPARIN SODIUM injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A)

Commercializzato da:

General Injectables & Vaccines, Inc

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Heparin Sodium Injection 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 fibrilation with embolization; Diagnosis and 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 and in blood samples for laboratory purposes. Heparin sodium should NOT be used in patients with the following conditions: Severe thrombocytopenia; When suitable blood coagulation tests, e.g.,

Dettagli prodotto:

Heparin Sodium Injection, USP (porcine), preservative free , is available as follows: Preservative Free Discard Unused Portion. Do not use if solution is discolored or contains a precipitate. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: Use only if solution is clear and seal intact. Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: *Packaged in a plastic or glass vial. **Packaged in a plastic vial. The above products are available in multiple dose, flip-top vials packaged in 25. Do not use if solution is discolored or contains a precipitate.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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HEPARIN SODIUM 1000 UN/ML INJECTION, USP 1 ML MULTI DOSE VIAL
DES CRIPTION
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) 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)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.
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), preservative free, is
available as follows:
Each mL of the 1,000 Units per mL preparation contains: 1,000 USP
Heparin Units (porcine); 9 mg
sodium chloride; Water for Injection q.s. Made isotonic with sodium
chloride. Hydrochloric acid
and/or sodium hydroxide may have been added for pH adjustment
(5.0-7.5).
Heparin Sodium Injection, USP (porcine), preserved with benzyl
alcohol, is available as follows:
Each mL of the 5,000 Units per mL preparation contains: 5,000 USP
Heparin Units (porcine); 6 mg
sodium chloride; 15 mg benzyl alcohol (as a preservative); Water for
Injection q.s. Hydrochloric ac