HEPARIN SODIUM injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

heparin sodium (UNII: ZZ45AB24CA) (heparin - UNII:T2410KM04A)

זמין מ:

Sagent Pharmaceuticals

INN (שם בינלאומי):

heparin sodium

הרכב:

heparin 1000 [USP'U] in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Heparin Sodium Injection is indicated for: - Prophylaxis and treatment of venous thrombosis and pulmonary embolism; - 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; - 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. - Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. The use of heparin sodium is contraindicated in patients with the following conditions: - History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)] ; - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1)]; -

leaflet_short:

Heparin Sodium Injection, USP (porcine), preservative-free , is available as follows: Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

HEPARIN SODIUM- HEPARIN SODIUM INJECTION
SAGENT PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HEPARIN SODIUM
INJECTION.
HEPARIN SODIUM INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Heparin Sodium Injection is an anticoagulant indicated for (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
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
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
Use as an anticoagulant in blood transfusions, extracorporeal
circulation, and dialysis procedures
DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
Therapeutic Anticoagulant Effect with Full-Dose Heparin (2.3)
† Based on 150 lb (68 kg) patient. Adjust dose based on laboratory
monitoring.
Deep Subcutaneous (Intrafat)
Injection _Use a different site_
_for each injection_
Initial Dose
5,000 units by intravenous injection followed by
10,000 to 20,000 units of a concentrated
solution, subcutaneously
Every 8 hours or
Every 12 hours
8,000 to 10,000 units of a concentrated solution
15,000 to 20,000 units of a concentrated solution
Intermittent Intravenous
Injection
Initial dose
10,000 units, either undiluted or in 50 to 100 mL
of 0.9% Sodium Chloride Injection
Every 4 to 6 hours
5,000 to 10,000 units, either undiluted or in 50 to
100 ml of 0.9% Sodium Chloride Injection
Intravenous Infusion
Initial dose
5,000 units by intravenous injection
Continuous
20,000 to 40,000 units/24 hours in 1,000 mL of
0.9% Sodium Chloride Injection (or in any
compat