Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ENOXAPARIN SODIUM
B & S Healthcare
ENOXAPARIN SODIUM
100 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER CLEXANE ® SYRINGES 100MG/ML SOLUTION FOR INJECTION (enoxaparin sodium) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Clexane is and what it is used for 2. Before you use Clexane 3. How to use Clexane 4. Possible side-effects 5. How to store Clexane 6. Further information 1. WHAT CLEXANE IS AND WHAT IT IS USED FOR The name of your medicine is Clexane Syringes 100mg/ml Solution for Injection (called Clexane in this leaflet). Clexane contains a medicine called enoxaparin sodium. This belongs to a group of medicines called Low Molecular Weight Heparins. CLEXANE WORKS IN TWO WAYS. 1) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stop them causing you harm. 2) Stopping blood clots forming in your blood. CLEXANE CAN BE USED TO: Treat blood clots that are in your blood Stop blood clots forming in your blood in the following situations: Unstable angina (where not enough blood gets to your heart) or a type of heart attack called NSTEMI After an operation or long periods of bed rest due to illness Stop blood clots forming in the tubes of your dialysis machine (used for people with kidney problems) 2. BEFORE YOU USE CLEXANE Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clexane Syringes 100mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clexane Syringes (100mg/ml) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. _Product imported from Spain_: Sterile pryogen-free solution for injection contained in ready-to-use pre-filled syringes. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery. The prophylaxis of venous thromboembolism in medical patients bedridden due to acute illnesses including cardiac insufficiency, respiratory failure, or severe infections. 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). The prevention of thrombus formation in the extracorporeal circulation during haemodialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Prophylaxis of venous thromboembolism in surgical patients In patients with a moderate risk of venous thromboembolism, the recommended dosage of enoxaparin sodium is 20mg (2,000 IU) once daily by subcutaneous injection. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk of thromboembolism, such as in orthopaedic surgery, the recommended dosage of enoxaparin sodium given by subcutaneous injection is 40mg (4,000 IU) once daily with the in Przeczytaj cały dokument