Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ENOXAPARIN SODIUM
Sanofi-Aventis Ireland Limited
300/3 Mg/Ml
Solution for Injection
2009-06-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clexane Multi Dose 300 mg/3 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE 3 ml Enoxaparin Sodium Ph. Eur. 300.0 mg (EQUIVALENT TO 30,000 IU ANTI-XA ACTIVITY) Every 1 ml contains 100 mg Enoxaparin Sodium Ph. Eur. (equivalent to 10,000 IU anti-Xa activity). EXCIPIENTS Benzyl alcohol Ph. Eur. 45.0 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection Sterile, colourless to slightly yellow solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthapaedic or general surgery The prophylaxis of venous thromboembolism in medical patients bedridden due to acute illnesses including cardiac insufficiency, respiratory failure or severe infections. The treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or both. The treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with asprin. Treatment of acute ST-segment Elevation Myocardial Infraction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI). The prevention of thrombus formation in the extracorporeal circulation during haemodialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Prophylaxis of venous thromboembolism in surgical patients In patients with a moderate risk of venous thromboembolism, the recommended dosage of enoxaparin sodium is 20mg (2,000 IU) once daily by subcutaneous injection. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk of thromboem Read the complete document