Страна: Мальта
Язык: английский
Источник: Medicines Authority
ENOXAPARIN SODIUM
Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy
B01AB05
ENOXAPARIN SODIUM 100 mg/ml
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
ENOXAPARIN SODIUM 100 mg/ml
POM
ANTITHROMBOTIC AGENTS
Authorised
2006-02-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 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 is and what it is used for 2. What you need to know before you use Clexane 3. How to use Clexane 4. Possible side effects 5. How to store Clexane 6. Contents of the pack and other information 1. WHAT CLEXANE IS AND WHAT IT IS USED FOR Clexane contains the active substance called enoxaparin sodium. This belongs to a group of medicines call ‘low molecular weight heparin’ or LMWH. HOW CLEXANE WORKS Clexane 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 new blood clots from forming in your blood. WHAT CLEXANE IS USED FOR Clexane 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 a short-term illness and will not be able to move around for some time o if you have experienced a blood clot due to cancer to prevent further clots from f Прочитать полный документ
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 _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 water 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 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 disea Прочитать полный документ