Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Protamine sulphate
LEO Pharma A/S
V03AB; V03AB14
Protamine sulphate
1400 international unit(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Antidotes; protamine
Marketed
2006-11-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PROTAMINE SULPHATE LEO PHARMA 1400 ANTI-HEPARIN IU/ML (CORRESPONDS TO 10 MG/ML) SOLUTION FOR INJECTION AND INFUSION Protamine sulphate 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. A doctor or nurse usually administers this product. If you have any further questions ask your doctor, nurse or pharmacist. If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Protamine sulphate LEO Pharma is and what it is used for 2. What you need to know before you use Protamine sulphate LEO Pharma 3. How to use Protamine sulphate LEO Pharma 4. Possible side effects 5. How to store Protamine sulphate LEO Pharma 6. Contents of the pack and other information 1. WHAT PROTAMINE SULPHATE LEO PHARMA IS AND WHAT IT IS USED FOR The active ingredient is protamine sulphate, which is used as an anti-heparin, to block the action of heparin and low molecular weight heparins, and to reduce the effect of these substances on the body. Heparins are used to prevent your blood from clotting and they may cause bleeding. You may be given this medicine: To help stop bleeding which has been caused by heparin/low molecular weight heparin To prevent a lot of bleeding if you have been treated with heparin/low molecular weight heparin and are going to have surgery To reverse the effect of heparin used for some types of heart surgery 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROTAMINE SULPHATE LEO PHARMA DO NOT USE PROTAMINE SULPHATE LEO PHARMA: if you are allergic to protamine sulphate or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Protamine sulphate LEO Pharma if you are a diabetic using insulin (particularly protamine insulin) Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Protamine sulphate LEO Pharma 1400 anti-heparin IU/ml solution for injection and infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Protamine sulphate 1400 anti-heparin IU/ml (corresponds to 10 mg/ml) extracted from the sperm of_ Onchorhynchus_ _keta_ (salmon). 1 ml contains 1400 anti-heparin IU protamine sulphate (10 mg) 5 ml contains 7000 anti-heparin IU protamine sulphate (50 mg) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection and infusion. Clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Protamine sulphate can be used - in the treatment of overdosage or haemorrhage during heparin or Low Molecular Weight Heparin (LMWH) therapy - to counteract the anticoagulant effects of heparin or LMWH before emergency surgery. - to reverse the anticoagulant effects of heparin in cardiopulmonary bypass procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Protamine sulphate is administered as a slow intravenous injection over a period of about 10 minutes or as a constant, slow intravenous infusion. The largest single injection (bolus dose) should not exceed 5 ml (7000 anti-heparin IU/50 mg protamine sulphate). Ideally the dose should be guided by blood coagulation studies. The activated partial thromboplastin time (APTT) activated clotting time (ACT), anti Xa and bedside protamine neutralisation test are adequate for this purpose. Coagulation tests are usually performed 5 to 15 minutes after protamine sulphate administration. Further doses may be needed because protamine sulphate is cleared from the blood more rapidly than heparin and especially LMWH. The prolonged absorption after subcutaneous administration of heparin or LMWH might also indicate that repeated doses must be given. _NEUTRALISATION OF HEPARIN_: 1 ml of Protamine sulphate LEO Pharma (10 mg protamine sulphate) will neutralise approximately 1400 IU of heparin. As heparin has a relatively short half-life when giv Perskaitykite visą dokumentą