Страна: Мальта
Язык: английский
Источник: Malta Medicines Authority
HEPARIN SODIUM
Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France
B01AB01
HEPARIN SODIUM 5000 IU/ml
SOLUTION FOR INJECTION
HEPARIN SODIUM 5000 IU/ml
POM
ANTITHROMBOTIC AGENTS
Authorised
2018-05-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HEPARIN SODIUM 5,000 I.U./ML, SOLUTION FOR INJECTION Heparin sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Heparin sodium 5,000 I.U./ml is and what it is used for 2. What you need to know before you are given Heparin sodium 5,000 I.U./ml 3. How Heparin sodium 5,000 I.U./ml is given 4. Possible side effects 5. How to store Heparin sodium 5,000 I.U./ml 6. Contents of the pack and other information 1. WHAT HEPARIN SODIUM 5,000 I.U./ML IS AND WHAT IT IS USED FOR The name of this medicine is Heparin sodium 5,000 I.U./ml, solution for injection (referred to as ‘Heparin sodium 5,000 I.U./ml’ in this leaflet). Heparin sodium 5,000 I.U./ml belongs to a group of medicines called anticoagulants. Heparin prevents blood clotting. Heparin sodium 5,000 I.U./ml is used to treat and prevent: • blood clots in leg veins (deep vein thrombosis) • blood clots in the lung (pulmonary embolism) as well as for: • the treatment of chest pains resulting from disease of the heart arteries (unstable angina pectoris) • the treatment of severe blockages affecting arteries in the legs (acute peripheral arterial occlusion) • the prevention of blood clots in the heart following a heart attack (mural thrombosis). It is also used during heart and lung operations and during kidney dialysis. 2 . WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEPARIN SODIUM 5,000 I.U./ML YOU SHOULD NOT BE GIVEN HEPARIN SODIUM 5,000 I.U./ML IF YOU: - are allergic to heparin or any of the other ingred Прочитать полный документ
ANNEXE I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Heparin sodium 5,000 I.U./ml, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule with 1 ml solution for injection contains 5,000 I.U. of sodium heparin (from porcine intestinal mucosa). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL IPARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prophylaxis of deep vein thrombosis and pulmonary embolism. - Treatment of deep vein thrombosis and pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion. - Prophylaxis of mural thrombosis following myocardial infarction. - In extracorporeal circulation and haemodialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection, or by subcutaneous injection. The intravenous injection volume of heparin injection should not exceed 15ml. As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections. Posology Prophylaxis of deep vein thrombosis and pulmonary embolism _Adults:_ 2 hours pre-operatively: 5,000 units subcutaneously followed by: 5,000 units subcutaneously every 8-12 hours, for 7-10 days or until the patient is fully ambulant. No laboratory monitoring should be necessary during low dose heparin prophylaxis. If monitoring is considered desirable, anti-Xa assays should be used as the activated partial thromboplastin time (APTT) is not significantly prolonged. During pregnancy: 5,000 - 10,000 units every 12 hours, subcutaneously, adjusted according to APTT or anti-Xa assay _Elderly:_ Dosage reduction and monitoring of APTT may be advisable. _Paediatric population:_ No dosage recommendations. Treatment of deep vein thrombosis and pulmonary embolism: _Adults:_ Loading dose: 5,000 units intravenously (10,000 units may be requir Прочитать полный документ