البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Enoxaparin sodium
Laboratorios Farmacéuticos ROVI, S.A.
B01AB; B01AB05
Enoxaparin sodium
4000 international unit(s)/millilitre
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Heparin group; enoxaparin
Not marketed
2018-07-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AROVI 4,000 IU (40 MG)/0.4 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, 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 Arovi is and what it is used for 2. What you need to know before you use Arovi 3. How to use Arovi 4. Possible side effects 5. How to store Arovi 6. Contents of the pack and other information 1. WHAT AROVI IS AND WHAT IT IS USED FOR Arovi contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH). Arovi 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. Arovi 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 If you have experienced a blood clot due to cancer to prevent further clots from forming 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 machine (used for people with severe kidne اقرأ الوثيقة كاملة
Health Products Regulatory Authority 24 January 2023 CRN00D7PP Page 1 of 21 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 Arovi 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _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. 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 (Injection). Clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arovi 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. Acute coronary syndrome: Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsal اقرأ الوثيقة كاملة