Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENOXAPARIN SODIUM (HEPARIN)
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
ENOXAPARIN SODIUM (HEPARIN)
10 Pre-Filled Syringes; 2Units Units; 2 Pre-Filled Syringes
SANOFI WINTHROP INDUSTRIE
Not Applicable Baca dokumen lengkap
MY/CLE/1121/CCDSv13 1 CLEXANE ® 2000 IU (20 MG)/0.2 ML CLEXANE ® 4000 IU (40 MG)/0.4 ML CLEXANE ® 6000 IU (60 MG)/0.6 ML ENOXAPARIN SODIUM SOLUTION FOR INJECTION IN PREFILLED SYRINGE The package insert is continually updated: please read carefully before using a new pack. In case of any question, please contact your physician or pharmacist. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: enoxaparin sodium. Solvent: water for injections. Each ml of the solution contains 10000 IU equivalent to 100 mg enoxaparin sodium. One mg (0.01 ml) of enoxaparin sodium corresponds approximately to 100 anti-Xa IU. CLEXANE 2000 IU is equivalent to 20 mg, CLEXANE 4000 IU is equivalent to 40 mg, CLEXANE 6000 IU is equivalent to 60 mg. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Enoxaparin sodium is indicated in adults for: • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. • Prevention of thrombus formation in extracorporeal circulation during hemodialysis _ _ • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure , respiratory insufficiency, severe infection or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI). POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients _ Individual thromboembolic risk for patients can be estimated using v Baca dokumen lengkap