Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
ENOXAPARIN SODIUM
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Pending
10000 anti-Xa IU (100mg)/1ml
INJECTION
SUBCUTANEOUS, INTRAVASCULAR
Prescription Only
Sanofi Winthrop Industrie
2012-02-06
CLEXANE ® [sanofi logo] PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT Concentration of 10000 anti-Xa IU equivalent to 100 mg enoxaparin sodium in each ml of the solution: Clexane 2000 anti-Xa IU/0.2 ml Clexane 4000 anti-Xa IU/0.4 ml Clexane 6000 anti-Xa IU/0.6 ml Clexane 8000 anti-Xa IU/0.8 ml Clexane 10000 anti-Xa IU/1.0 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: Enoxaparin sodium Solvent: Water for injection Each ml of the solution contains 10000 anti-Xa IU equivalent to 100 mg enoxaparin sodium. One mg (0.01 ml) of enoxaparin sodium corresponds approximately to 100 anti-Xa IU. CLEXANE 2000 anti-Xa IU is equivalent to 20 mg, CLEXANE 4000 anti-Xa IU is equivalent to 40 mg, CLEXANE 6000 anti-Xa IU is equivalent to 60 mg, CLEXANE 8000 anti-Xa IU is equivalent to 80 mg and CLEXANE 10000 anti-Xa IU is equivalent to 100 mg. 3. PHARMACEUTICAL FORM Solution for injection CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery. Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses. Treatment of established deep vein thrombosis. Prevention of thrombus formation in extracorporeal circulation during haemodialysis. Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Prophylaxis of venous thromboembolic disease in surgical patients: In patients with a moderate thromboembolism r Belgenin tamamını okuyun