Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
B. Braun Medical Inc.
HEPARIN SODIUM
HEPARIN 4000 [USP'U] in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Heparin Sodium in 5% Dextrose Injection is indicated for: - Prophylaxis and treatment of venous thrombosis and pulmonary embolism - Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation - Treatment of acute and chronic consumption 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 in 5% Dextrose Injection is contraindicated in patients with the following conditions: - History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) [see Warnings and Precautions (5.3)] - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)] - In whom suitable blood coagulation tests – e.g., the whole blood clotti
Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in single-dose EXCEL® Containers packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
New Drug Application
HEPARIN SODIUM IN DEXTROSE- HEPARIN SODIUM AND DEXTROSE INJECTION B. BRAUN MEDICAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HEPARIN SODIUM IN 5% DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HEPARIN SODIUM IN 5% DEXTROSE INJECTION. HEPARIN SODIUM IN 5% DEXTROSE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1939 INDICATIONS AND USAGE Heparin sodium is indicated for: (1) Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; Treatment of acute and chronic consumption 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. DOSAGE AND ADMINISTRATION Recommended Adult Dosages: Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3) Intermittent Intravenous Injection Initial Dose 10,000 Units Subsequent Doses 5,000 to 10,000 Units every 4 to 6 hours Continuous Intravenous Infusion Initial Dose 5,000 Units by intravenous injection Continuous 20,000 to 40,000 Units every 24 hours * Based on 150 lb. (68 kg) patient. Cardiovascular Surgery (2.5) Intravascular via Total Body Perfusion Initial Dose Greater than or equal to 150 units/kg; adjust for longer procedures Extracorporeal Dialysis (2.8) Intravascular via Extracorporeal Dialysis Follow equipment manufacturer's operating directions carefully. For pediatric dosing see section 2.4 of full prescribing information. DOSAGE FORMS AND STRENGTHS Heparin Sodium 20,000 USP units per 500 mL (40 USP units per mL) in 5% Dextrose Injection (3) Heparin Sodium 25,000 USP units per 500 mL (50 USP units per mL) in 5% Dextrose Injection (3) Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection (3) CONTRAINDICAT Läs hela dokumentet