Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A)
General Injectables & Vaccines, Inc
Heparin Sodium
Heparin 1000 [USP'U] in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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)] - In whom su
Heparin Sodium Injection, USP preserved with benzyl alcohol is available as follows: 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.]
Abbreviated New Drug Application
HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HEPARIN SODIUM INJECTIONHIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE 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 USEINITIAL U.S. APPROVAL: 1939 INDICATIONS AND USAGE Heparin Sodium Injection is an anticoagulant indicated for (1) (2) (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: (3) (2) Therapeutic Anticoagulant Effect with Full-Dose Heparin Sodium Injection (2.3) (3) (2) (3) (2) Deep Subcutaneous (Intrafat) Injection (3) (2) Use a different site for each injection (3) (2) Initial Dose (3) (2) 5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously (3) (2) Every 8 hours (3) (2) (3) (2) Or (3) (2) (3) (2) Every 12 hours (3) (2) 8,000 to 10,000 units of a concentrated solution (3) (2) (3) (2) 15,000 to 20,000 units of a concentrated solution (3) (2) (3) (2) (3) (2) Intermittent Intravenous Injection (3) (2) Initial dose (3) (2) 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP (3) (2) Every 4 to 6 hours (3) (2) 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Baca dokumen lengkap