Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Heparin sodium
Wockhardt UK Limited
B01AB; B01AB01
Heparin sodium
1000 international unit(s)/millilitre
Solution injection or concentrate for solution infusion
Product subject to prescription which may not be renewed (A)
Heparin group; heparin
Marketed
1985-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER HEPARIN SODIUM 1,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION PRESERVATIVE FREE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, please 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion. In the rest of this leaflet it is called heparin injection. WHAT IS IN THIS LEAFLET 1. What heparin injection is and what it is used for 2. What you need to know before you are given heparin injection 3. How heparin injection is given 4. Possible side effects 5. How to store heparin injection 6. Contents of the pack and other information 1. WHAT HEPARIN INJECTION IS AND WHAT IT IS USED FOR Heparin belongs to a group of drugs that are called anti-coagulants. These help to stop blood clotting. Heparin injection is used in conditions where blood vessels may become blocked by blood clots. It is therefore used to treat: • 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) It is also used during heart and lung operations and during kidney dialysis. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEPARIN INJECTION THIS MEDICINE SHOULD NOT BE INJECTED INTO YOUR MUSCLES THIS MEDICINE SHOULD NOT BE USED AFTER MAJOR TRAUMA HEPARIN INJECTION SHOULD N Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Heparin sodium 1,000 I.U./ml Solution for injection or concentrate for solution for infusion, 5ml ampoules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Heparin sodium 1,000 I.U./ml (5,000 I.U. in 5ml) For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Solution for injection or concentrate for solution for infusion. A colourless or straw-coloured liquid free from turbidity and matter that deposits on standing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion. In extracorporeal circulation and haemodialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration_ By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection. As the effects of heparin are short-lived, administration by intravenous infusion is preferable to intermittent intravenous injections. _Recommended dosage_ TREATMENT OF DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, UNSTABLE ANGINA PECTORIS, ACUTE PERIPHERAL ARTERIAL OCCLUSION: _Adults:_ Loading dose: 5,000 units intravenously (10,000 units may be required in severe pulmonary embolism) Maintenance: 1,000-2,000 units/hour by intravenous infusion, or 5,000-10,000 units 4-hourly by intravenous injection. _Elderly:_ Dosage reduction may be advisable. _Children and small adults:_ Loading dose: 50 units/kg intravenously H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document