Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Enoxaparin sodium
Sanofi-Aventis Ireland Limited T/A SANOFI
B01AB; B01AB05
Enoxaparin sodium
120 milligram(s)
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Heparin group; enoxaparin
Authorised
2017-07-14
PACKAGE LEAFLET: INFORMATION FOR THE USER CLEXANE® 2,000 IU (20MG)/0.2ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES CLEXANE® 4,000 IU (40MG)/0.4ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES CLEXANE® 6,000 IU (60MG)/0.6ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES CLEXANE® 8,000 IU (80MG)/0.8ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES CLEXANE® 10,000 IU (100MG)/1ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES CLEXANE® FORTE 12,000 IU (120MG)/0.8ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES CLEXANE® FORTE 15,000 IU (150MG)/1ML SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGES _enoxaparin sodium _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ WITH ERIS NEEDLE GUARD SAFETY SYSTEM 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 . 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 called ‘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 fro Lees het volledige document
Health Products Regulatory Authority 18 February 2022 CRN00CT3T Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clexane Forte 12,000 IU (120mg) / 0.8 mL Solution for Injection in pre-filled syringes 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains enoxaparin sodium 12,000 IU anti-Xa activity (equivalent to 120 mg) in 0.8 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 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. Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer. Prevention of thrombus formation in extracorporeal 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 intervention (PCI). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prophylaxis of Lees het volledige document