** CLEXANE® (enoxaparin sodium) 4000anti-Xa IU/0.4ml 2 pre-filled syringes. Injectable solution. Subcutaneous route.

** Heparin analougue, S.C. injection (except when used for dialysis). Intravascular route during hemodialysis. Do not inject intramuscularly.

** Composition: For one pre-filled syringe: Enoxaparin sodium 40 mg Water for injections q.s. ad 0.4 ml

** When should this drug be used (Therapeutic indications): Solution for injection (containing 2000 anti-Xa IU and 4000 anti-Xa IU: – Prophylaxis of thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopaedic or general surgery. – Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illness, including cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases.

** Posology and method of administration: – Prophylaxis of venous thromboembolic disease in surgical patients: In patients with a moderate thromboembolism risk (e.g. abdominal surgery) the recommended dosage is 2000 anti-Xa IU (0.2 mL) or 4000 anti-Xa IU (0.4 mL) once daily by SC injection. In general surgery, the first injection should be given 2 hours before the surgical procedure. In patients with a high risk of thromboembolism (e.g. orthopaedic surgery) the recommended dose of enoxaparin sodium given by SC injection is 4000 anti-Xa IU (0.4 mL) once daily initiated 12 hours preoperatively. For special recommendations concerning dosing intervals for spinal/epidural anesthesia and percutaneous coronary revascularization procedures, see Warnings. Enoxaparin sodium treatment is usually prescribed for an average period of 7 to 10 days. Longer treatment duration may be appropriate in some patients and the treatment should be continued for as long as there is a risk of venous thromboembolism and until the patient is ambulatory. Continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopedic surgery. – Prophylaxis of venous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is 4000 anti-Xa IU (0.4 mL) once daily by SC injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.

** Contraindications: – in patients with known hypersensitivity (allergy) to either enoxaparin sodium, heparin or other Low Molecular Weight Heparins. – in patients with active major bleeding and conditions with a high risk of uncontrolled haemorrhage, including recent haemorrhagic stroke.

** Special warnings: – Low Molecular Weight Heparins should not be used interchangeably since they differ in their manufacturing process, molecular weights, specific anti Xa activities, units and dosage. Very careful attention and compliance with the specific instructions on use of each product are absolutely essential. – Spinal / Epidural anesthesia. – Heparin-induced thrombocytopenia: Enoxaparin sodium is to be used with extreme caution in patients with a history of heparin-induced thrombocytopenia (decrease in blood platelet count) with or without thrombosis. – Percutaneous coronary revascularisation procedures. – Pregnant women with mechanical prosthetic heart valves. – Laboratory tests.

** Precautions: – Bleeding: As with other anticoagulants, bleeding may occur at any site. If bleeding occurs, the origin of the haemorrhage should be investigated and appropriate treatment instituted. – Mechanical prosthetic heart valves. – Haemorrhage in the elderly. – Renal impairment. – Low weight. – Monitoring of platelet count.

** Pregnancy and lactation: In humans, there is no evidence that enoxaparin crosses the placental barrier during the second trimester of pregnancy. There is no information available concerning the first and the third trimesters. As there are no adequately powered and well-controlled studies in pregnant women enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women with mechanical prosthetic heart valves may be at a higher risk of thromboembolism. As a precaution, lactating mothers receiving enoxaparin sodium should be advised to avoid breast-feeding.

** Prescription only medicine – List I. Use the dose as prescribed.

** Read carefully the package insert before use.

** Do not store above 25 degrees C. Keep out of the reach and sight of children.

** sanofi-aventis France 1-13, boulevard Romain Rolland 75014 Paris – France

Manufacturer: SANOFI WINTHROP INDUSTRIE 180, rue Jean Jaures 94702 Maisons-Alfort Cedex – France