Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sanofi-Aventis South Africa (Pty) Ltd
See ingredients
INJECTION
EACH 0,6 ml SOLUTION CONTAINS ENOXAPARIN SODIUM 60,0 mg
Registered
2000-05-03
Page 1 of 6 PATIENT INFORMATION LEAFLET Read all of this leaflet carefully before you are given CLEXANE. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. CLEXANE has been prescribed for you personally. SCHEDULING STATUS: S4 NAME OF MEDICINAL PRODUCT: CLEXANE 20 (Injection) CLEXANE 40 (Injection) CLEXANE 60 (Injection) CLEXANE 80 (Injection) CLEXANE 100 (Injection) CLEXANE 300 (Injection) WHAT CLEXANE CONTAINS The active ingredient in CLEXANE is enoxaparin sodium. Each prefilled syringe contains: CLEXANE 20: 20 mg enoxaparin sodium per 0,2 ml CLEXANE 40: 40 mg enoxaparin sodium per 0,4 ml CLEXANE 60: 60 mg enoxaparin sodium per 0,6 ml CLEXANE 80: 80 mg enoxaparin sodium per 0,8 ml CLEXANE 100: 100 mg enoxaparin sodium per 1,0 ml The only other ingredient in the prefilled syringes is: water for injection. The multidose vial contains: CLEXANE 300: 300 mg enoxaparin sodium per 3 ml. The other ingredients in the multidose vial are: benzyl alcohol (preservative) and water for injection. WHAT CLEXANE IS USED FOR Page 2 of 6 CLEXANE is one of a group of medicines called low molecular weight heparins (LMWH). These medicines work by reducing blood clotting activity. CLEXANE is used in a number of medical conditions. It is used to: treat blood clots in veins treat certain types of heart disease (e.g. angina and heart attacks), when used with aspirin prevent blood clots forming after an operation, during hospitalisation or extended bed rest or during purification of the blood by an artificial kidney (haemodialysis). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CLEXANE HAS BEEN PRESCRIBED FOR YOU. CLEXANE is only available with a doctor’s prescription. BEFORE YOU USE CLEXANE YOU SHOULD NOT RECEIVE CLEXANE IF YOU HAVE OR HAVE EVER HAD: an allergy to CLEXANE, heparin or its derivatives including other LMWHs or benzyl alcohol. Some signs and symptoms of an allergic reaction can include swelling o Read the complete document
Page 1 of 16 SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: CLEXANE 20 (Injection) CLEXANE 40 (Injection) CLEXANE 60 (Injection) CLEXANE 80 (Injection) CLEXANE 100 (Injection) CLEXANE 300 (Injection) COMPOSITION: CLEXANE 20: Enoxaparin sodium 20 mg per 0,2 ml CLEXANE 40: Enoxaparin sodium 40 mg per 0,4 ml CLEXANE 60: Enoxaparin sodium 60 mg per 0,6 ml CLEXANE 80: Enoxaparin sodium 80 mg per 0,8 ml CLEXANE 100: Enoxaparin sodium 100 mg per 1,0 ml CLEXANE 300: Per multidose vial: Enoxaparin sodium 300 mg Benzyl alcohol (preservative) 1,5 % m/v Water for injection to 3,0 ml PHARMACOLOGICAL CLASSIFICATION: A 8.2 Anticoagulants PHARMACOLOGICAL ACTION: Enoxaparin sodium is a low molecular weight heparin which has a greater antithrombotic (anti- Factor Xa) activity than a thrombolytic effect (anti-Factor IIa activity)_ in vivo_. It is well absorbed after subcutaneous injection, with a half-life of the anti-Factor Xa activity of 4,5 hours. This is increased to 6,7 hours in the elderly. The anti-Factor Xa activity disappears within 24 hours after administration of the recommended dose. Page 2 of 16 Heparins are metabolised in the liver by the enzyme heparinase. The heparin half-life is significantly prolonged in patients with cirrhosis of the liver. A 30 mg IV bolus immediately followed by a 1 mg/kg SC every 12 hours provided initial peak anti-Factor Xa levels of 1,16 IU/ml and average exposure corresponding to 88 % of steady-state levels. Steady-state is achieved on the second day of treatment. _CHARACTERISTICS IN SPECIAL POPULATIONS: _ ELDERLY: Since renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium (refer to Special Precautions – Haemorrhage in the elderly; DOSAGE AND DIRECTIONS FOR USE – Elderly & Pharmacological Action - Renal impairment). RENAL IMPAIRMENT: A linear relationship between anti-Xa plasma clearance and creatinine clearance at steady-state has been observed, which indicates decreased clearance of enoxaparin Read the complete document