Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Enoxaparin sodium
Venipharm
B01AB05
Enoxaparin sodium
Solution for injection in pre-filled syringe
enoxaparin
Not marketed
2022-09-16
PACKAGE LEAFLET: INFORMATION FOR THE USER Enoxaparin sodium Ledraxen 2,000 IU (20 mg)/0.2 mL solution for injection in pre- filled syringe Enoxaparin sodium Ledraxen 4,000 IU (40 mg)/0.4 mL solution for injection in pre- filled syringe Enoxaparin sodium Ledraxen 6,000 IU (60 mg)/0.6 mL solution for injection in pre- filled syringe Enoxaparin sodium Ledraxen 8,000 IU (80 mg)/0.8 mL solution for injection in pre- filled syringe Enoxaparin sodium Ledraxen 10,000 IU (100 mg)/1 mL solution for injection in pre- filled syringe enoxaparin sodium This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Enoxaparin sodium Ledraxen is and what it is used for 2. What you need to know before you use Enoxaparin sodium Ledraxen 3. How to use Enoxaparin sodium Ledraxen 4. Possible side effects 5. How to store Enoxaparin sodium Ledraxen 6. Contents of the pack and other information 1. WHAT ENOXAPARIN SODIUM LEDRAXEN IS AND WHAT IT IS USED FOR Enoxaparin sodium Ledraxen contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH). Enoxaparin sodium Ledraxen 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 for Læs hele dokumentet
Health Products Regulatory Authority 06 October 2023 CRN00DKFY Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Enoxaparin sodium Ledraxen 6,000 IU (60 mg)/0.6 mL, solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10,000 IU/mL (100 mg/mL) solution for injection in pre-filled syringe _6,000 IU(60 mg)/0.6mL_ Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 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 syringe. Colourless or light yellow transparent liquid, the pH of the solution is between 5.5 and 7.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enoxaparin sodium Ledraxen 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 extra corporeal circulation during haemodialysis. Acut Læs hele dokumentet