HEPARIN SODIUM injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cardinal Health

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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; 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

leaflet_short:

Heparin Sodium Injection, USP (porcine), contains parabens and is available in multiple dose, flip-top vials, in packages of 25, as follows: Product No. NDC No.  Strength   Fill Volume                        NP926201* Overbagged with 5 vials per bag, NDC 55154-9397-5 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.

מצב אישור:

New Drug Application

מאפייני מוצר

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
CARDINAL HEALTH
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HEPARIN SODIUM INJECTION USP
Rx only
DERIVED FROM PORCINE INTESTINAL MUCOSA.
PRESERVED WITH 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 to 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 and/or sodium hydroxide may have been added for pH adjustment