HEPARIN SODIUM - heparin sodium injection, solution, concentrate

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

General Injectables & Vaccines, Inc

INN (International namn):

Heparin Sodium

Sammansättning:

Heparin Sodium 10000 [USP'U] in 5 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Bemyndigande status:

New Drug Application

Produktens egenskaper

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