Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
reteplase
Actavis Group PTC ehf
B01AD07
reteplase
Antithrombotic agents
Myocardial Infarction
Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.
Revision: 27
Authorised
1996-08-29
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER RAPILYSIN 10 U POWDER AND SOLVENT FOR SOLUTION FOR INJECTION reteplase 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 your pharmacist. - 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 Rapilysin is and what it is used for 2. What you need to know before Rapilysin is given to you 3. How to use Rapilysin 4. Possible side effects 5. How to store Rapilysin 6. Contents of the pack and other information 1. WHAT RAPILYSIN IS AND WHAT IT IS USED FOR Rapilysin contains the active substance reteplase(a recombinant plasminogen activator). It is a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these blocked vessels (=thrombolysis). Rapilysin is used after an acute myocardial infarction (heart attack) in order to dissolve the blood clot causing the heart attack. It is given within 12 hours after the onset of symptoms. 2. WHAT YOU NEED TO KNOW BEFORE RAPILYSIN IS GIVEN TO YOU The doctor will ask you questions before giving you Rapilysin, to find out if you have an increased risk of bleeding. DO NOT USE RAPILYSIN • if you are allergic to reteplase or any of the other ingredients of this medicine (listed in section 6). • if you have a bleeding disorder. • if you are taking medicine to thin your blood (oral anticoagulants, e.g. warfarin). • if you have a brain tumour or a malformed blood vessel or a vessel wall dilatation (aneurysm) in the brain. • if you have other tumours associated with an increased risk of bleeding. • if you have had a stroke. • if you have had external heart massage within the past 10 days. • if you have severe uncontrolled high blood press Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rapilysin 10 U powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections. The reconstituted solution contains 1 U reteplase per ml. For the full list of excipients, see section 6.1. * Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents. ** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder and clear colourless liquid (water for injections). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial infarction AMI symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with reteplase should be initiated as soon as possible after the onset of AMI symptoms. Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor its use. Posology _Dosage of Rapilysin _ Rapilysin is administered as a 10 U bolus dose followed by a second 10 U bolus dose 30 minutes later (double bolus). Each bolus is administered as a slow intravenous injection within 2 minutes. Ensure that the injection is not mistakenly given paravenously. _HEPARIN AND ACETYLSALICYLIC ACID _ should be administered before and following the administration of Rapilysin to reduce the risk of re-thrombosis. _Dosage of Heparin _ The recommended dose of heparin is 5000 I.U. given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I.U. per hour starting after the second reteplase bolus. Heparin should 3 be admin Прочетете целия документ