Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
ENOXAPARIN SODIUM
SANOFI - AVENTIS ISRAEL LTD
B01AB05
SOLUTION FOR INJECTION
ENOXAPARIN SODIUM 150 MG/ML
S.C, I.V
Required
AVENTIS PHARMA SPECIALITES, FRANCE
ENOXAPARIN
ENOXAPARIN
Clexane Forte is indicated in adults for: • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. • Prevention of thrombus formation in extra corporeal circulation during haemodialysis. • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary inte
2015-02-28
1 Clexane - SPC - 11.1 1. NAME OF THE MEDICINAL PRODUCT - Clexane 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes - Clexane 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringes - Clexane 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringes - Clexane 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringes - Clexane 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringes 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10,000 IU/mL (100 mg/mL) solution for injection _2,000 IU (20 mg) /0.2 mL_ Each pre-filled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections. _ _ _4,000 IU (40 mg) /0.4 mL_ Each pre-filled syringe contains enoxaparin sodium 4,000 IU anti-Xa activity (equivalent to 40 mg) in 0.4 mL water for injections. _ _ _6,000 IU (60 mg) /0.6 mL_ Each pre-filled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 mL water for injections. _ _ _8,000 IU (80 mg) /0.8 mL_ Each pre-filled syringe contains enoxaparin sodium 8,000 IU anti-Xa activity (equivalent to 80 mg) in 0.8 mL wat er for injections. _ _ _10,000 IU (100 mg) /1.0 mL_ Each pre-filled syringe contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections. For the full list of excipients, see section 6.1. Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringes. Clear, colourless to yellowish solution, pH-value 5.5–7.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clexane syringes are indicated in adults for: • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. • Prophylaxis of venous thromboembolic disease in medical patients with an acute Διαβάστε το πλήρες έγγραφο