1 Summary OF PRODUCT CHARACTERISTICS. 1 NAME OF THE MEDICINAL PRODUCT. Clexane Multidose Vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION. Vials containing 300 mg enoxaparin (equivalent to 30,000 IU anti-Xa activity). in ml Contains benzyl alcohol (45mg in ml). For full list of excipients, see section 3 PHARMACEUTICAL FORM. Sterile pyrogen-free solution for injection contained in a Multidose vial for single patient use. Clear, colourless to slightly yellow solution 4 CLINICAL PARTICULARS. Therapeutic indications The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery.
2 The prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness. 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 aspirin. Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI). including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI) in conjunction with thrombolytic drugs (fibrin or non-fibrin specific).
3 The prevention of thrombus formation in the extracorporeal circulation during haemodialysis. Posology and method of administration Adults: Prophylaxis of venous thromboembolism: In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose administered approximately 12 hours before surgery.
4 Prophylaxis of venous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous 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. Treatment of venous thromboembolism: Clexane should be administered subcutaneously as a single daily injection of mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5. days and until adequate oral anticoagulation is established. Dosage chart for SC treatment of DVT, PE or both Patient weight Kg Dose Injection (mg) volume (ml) (1).
5 300mg/3ml 40 60 od Solution for Injection 45 od Clexane Multidose Vial 50 75 od 55 od 60 90 od 65 od 70 105 od 75 od 80 120 od 85 od 90 135 od 95 od 100 150 od (1) the injection volumes are those needed to achieve the required dose. However, rounding up dose adjustments may need to be taken into consideration depending on the graduations of the syringe used. Treatment of unstable angina and non-Q-wave myocardial infarction The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325 mg once daily).
6 Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days. Dosage chart for 1mg/kg SC treatment of UA or NSTEMI. Patient weight Kg Dose Injection (mg) volume (ml). 300mg/3ml 40 40 bd Solution for Injection 45 45 bd Clexane Multidose Vial 50 50 bd 55 55 bd 60 60 bd 65 65 bd 70 70 bd 75 75 bd 80 80 bd 85 85 bd 90 90 bd 95 95 bd 100 100 bd 105 105 bd 110 110 bd 115 115 bd 120 120 bd 125 125 bd 130 130 bd 135 135 bd 140 140 bd 145 145 bd 150 150 bd Treatment of acute ST-segment Elevation Myocardial Infarction.
7 The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients 75 years of age, see section Posology and method of administration: Elderly. Dosage chart for 1mg/kg SC treatment of STEMI. Patient weight Kg Dose (mg) Injection volume (ml). 300mg/3ml 40 40 bd Solution for Injection 45 45 bd Clexane Multidose Vial 50 50 bd 55 55 bd 60 60 bd 65 65 bd 70 70 bd 75 75 bd 80 80 bd 85 85 bd 90 90 bd 95 95 bd 100 100 bd 105 (1) 105 bd (1) (1).
8 110 (1) 110 bd (1) (1). 115 (1) 115 bd (1) (1). 120 (1) 120 bd (1) (1). 125 (1) 125 bd (1) (1). 130 (1) 130 bd (1) (1). 135 (1) 135 bd (1) (1). 140 (1) 140 bd (1) (1). 145 (1) 145 bd (1) (1). 150 (1) 150 bd (1) (1). (1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). When administered in conjunction with a thrombolytic (fibrin specific or non- fibrin specific) enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy.
9 All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained under (75 to 325mg once daily) unless contraindicated. The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first. For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of of enoxaparin sodium should be administered.
10 Prevention of extracorporeal thrombus formation during haemodialysis: A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of to 1 mg/kg (50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose should be reduced to mg/kg (50 IU/kg) for double vascular access or mg/kg (75 IU/kg) for single vascular access. Elderly: For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients 75 years of age, do not use an initial IV bolus.