HEPARIN SODIUM injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

HF Acquisition Co LLC, DBA HealthFirst

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

HEPARIN SODIUM INJECTION, USP is supplied in the following dosage forms. NDC 51662-1434-1 HEPARIN SODIUM INJECTION, USP 10,000 USP UNITS/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: 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.]

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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HEPARIN SODIUM INJECTION, USP 10,000 USP UNITS/ML 1ML VIAL
SPL UNCLASSIFIED
Rx 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 1,000 units per mL preparation contains: 1,000 USP
Heparin units (porcine); 9 mg
sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; 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).
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
acid an