HEPARIN SODIUM injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Cardinal Health

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 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 blood clotting time, partial thromboplastin ti

Sommarju tal-prodott:

Heparin Sodium Injection, USP (porcine) contains parabens and is available in multi-dose, flip-top vials, in packages of 25, as follows: Product No. NDC No. Strength Fill Volume 504011 Overbagged with 5 Multi-Dose vials per bag, NDC #55154-9360-5 10,000 USP Heparin units per 10 mL (1,000 USP Heparin units per mL) 10 mL fill in a 10 mL vial. 926201** Overbagged with 5 x 1 mL Multi-Dose Vials per bag, NDC #55154-9354-5 5,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. **Packaged in a plastic vial. 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.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
CARDINAL HEALTH
----------
HEPARIN SODIUM INJECTION USP
Rx only
DERIVED FROM PORCINE INTESTINAL MUCOSA.
Available as: Preservative Free OR Contains Benzyl Alcohol OR 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) 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)> (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), 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 to
7.5).
Each 0.5 mL of the 5,000 units per 0.5 mL preparation contains: 5,000
USP Heparin units (porcine);
Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may
have been added for pH
adjustment (5.0 to 7.5).
Heparin Sodium Injection, USP (porcine), preserved