البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Nadroparin calcium
Aspen Pharma Trading Limited
B01AB; B01AB06
Nadroparin calcium
2,850 I.U. anti-Xa/ 0.3 millilitre(s)
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Heparin group; nadroparin
Not marketed
2018-05-04
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER NADROPARIN CALCIUM ASPEN 2,850 I.U. anti-Xa/ 0.3 ml solution for injection in a pre-filled syringe. Nadroparin calcium 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. - 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 Nadroparin Calcium Aspen is and what it is used for 2. What you need to know before you take Nadroparin Calcium Aspen 3. How to use Nadroparin Calcium Aspen 4. Possible side effects 5. How to store Nadroparin Calcium Aspen 6. Contents of the pack and other information 1. WHAT NADROPARIN CALCIUM ASPEN IS AND WHAT IT IS USED FOR Nadroparin Calcium Aspen is an antithrombotic agent. It is a low-molecular weight heparin. NADROPARIN CALCIUM ASPEN IS USED FOR - Perioperative thrombosis prophylaxis, - Peri- and postoperative primary prophylaxis of deep vein thrombosis in patients with ○ low, moderate or high thromboembolic risk, ○ larger orthopedic surgeries (e.g. elective hip surgeries), - Prophylaxis to stop blood clots from forming in your blood when you have an acute illness and face period of limited mobility. - Treatment of deep vein thrombosis, - Thrombosis prophylaxis and anticoagulation with extracorporeal circulation during haemodialysis and hemofiltration. Note: The medicinal product is available in different strengths which are not suitable for all therapeutic indications (see section 3. How to use Nadroparin Calcium Aspen). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NADROPARIN CALCIUM ASPEN DO NOT USE NADROPARIN CALCIUM ASPEN - If you are allergic to the calcium, heparin o اقرأ الوثيقة كاملة
Health Products Regulatory Authority 29 January 2020 CRN009271 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nadroparin calcium Aspen 2,850 I.U. anti-Xa/ 0.3 ml solution for injection in a pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 9,500 I.U. anti-Xa Nadroparin-Calciumderived from porcine intestinal mucosa, equal to 95 to 130 I.U. anti-Xa/mg, a low molecular weight heparin with a mean molecular weight of 4,500 Dalton. 1 Pre-filled syringe with 0.3 ml solution for injection contains 2,850 I.U. anti-Xa Nadroparin-Calcium. For the full list of the excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. The solution is sterile and clear, pH 5.0 to 7.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Perioperative thrombosis prophylaxis: Peri- and postoperative primary prophylaxis of deep vein thrombosis in patients with low, moderate or high thromboembolic risk. Peri- and postoperative primary prophylaxis of deep vein thrombosis in patients with larger orthopaedic surgeries (e.g. elective hip surgeries) - 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. - Thrombosis prophylaxis and anticoagulation with extracorporeal circulation during haemodialysis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Perioperative thrombosis prophylaxis_ Peri- and postoperative primary prophylaxis of deep vein thrombosis - In patients with low, moderate or high thromboembolic risk 0.3 ml (2,850 I.U. anti-Xa) subcutaneously 2 hours before surgery, afterwards 0.3 ml (2,850 I.U. anti-Xa) subcutaneously every morning until the patient is fully mobilized, but at least for the duration of 7 days. - In patients with larger orthopaedic surgeries (e.g. elective اقرأ الوثيقة كاملة