Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
ENOXAPARIN SODIUM
Sanofi Malta Limited
B01AB05
ENOXAPARIN SODIUM
SOLUTION FOR INJECTION
ENOXAPARIN SODIUM 10 mg/ml
POM
ANTITHROMBOTIC AGENTS
Authorised
2006-02-24
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER CLEXANE® SYRINGES 2,000 IU (20 MG)/0.2 ML SOLUTION FOR INJECTION CLEXANE® SYRINGES 4,000 IU (40 MG)/0.4 ML SOLUTION FOR INJECTION CLEXANE® SYRINGES 6,000 IU (60 MG)/0.6 ML SOLUTION FOR INJECTION CLEXANE® SYRINGES 8,000 IU (80 MG)/0.8 ML SOLUTION FOR INJECTION CLEXANE® SYRINGES 10,000 IU (100 MG)/1 ML SOLUTION FOR INJECTION enoxaparin sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Clexane Syringes is and what it is used for 2. What you need to know before you use Clexane Syringes 3. How to use Clexane Syringes 4. Possible side effects 5. How to store Clexane Syringes 6. Contents of the pack and other information 1. WHAT CLEXANE SYRINGES IS AND WHAT IT IS USED FOR Clexane Syringes contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH). Clexane Syringes works in two ways. 1) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm 2) Stopping blood clots from forming in your blood. Clexane Syringes can be used to: Treat blood clots that are in your blood Stop blood clots from forming in your blood in the following situations: o Before and after an operation o When you have an acute illness and face period of limited mobility o When you have unstable angina (a condition when not enough blood gets to your heart) o After a heart attack Stop blood clots forming in the tubes of your dialysis machin Olvassa el a teljes dokumentumot
Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clexane ® 2,000 IU (20 mg)/0.2 mL solution for injection Clexane ® 4,000 IU (40 mg)/0.4 mL solution for injection Clexane ® 6,000 IU (60 mg)/0.6 mL solution for injection Clexane ® 8,000 IU (80 mg)/0.8 mL solution for injection Clexane ® 10,000 IU (100 mg)/1 mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _2,000 IU (20 mg) /0.2 mL _ Each prefilled 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 prefilled 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 prefilled 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 prefilled syringe contains enoxaparin sodium 8,000 IU anti-Xa activity (equivalent to 80 mg) in 0.8 mL water for injections. _10,000 IU (100 mg) /1.0 mL _ Each prefilled syringe contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections. For 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. Clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clexane is indicated in adults for: Page 2 of 24 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 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 venous thr Olvassa el a teljes dokumentumot