מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
tenecteplase
Boehringer Ingelheim International GmbH
B01AD11
tenecteplase
Antithrombotic agents
Myocardial Infarction
Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms.,
Revision: 22
Authorised
2001-02-23
46 B. PACKAGE LEAFLET 47 PACKAGE LEAFLET: INFORMATION FOR THE USER METALYSE 8 000 UNITS (40 MG) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION METALYSE 10 000 UNITS (50 MG) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION tenecteplase READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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. - 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 Metalyse is and what it is used for 2. What you need to know before you receive Metalyse 3. How is Metalyse administered 4. Possible side effects 5. How to store Metalyse 6. Contents of the pack and other information 1. WHAT METALYSE IS AND WHAT IT IS USED FOR Metalyse is a powder and solvent for solution for injection. Metalyse belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator. Metalyse is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE METALYSE METALYSE WILL NOT BE PRESCRIBED AND GIVEN BY YOUR DOCTOR if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to tenecteplase, to any of the other ingredients of this medicine (listed in section 6) or to gentamicin (a trace residue from the manufacturing process). If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need; if you have, or have recently had, an illness that increases your risk of bleeding (h קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Metalyse 8 000 units (40 mg) powder and solvent for solution for injection Metalyse 10 000 units (50 mg) powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Metalyse 8 000 units (40 mg) powder and solvent for solution for injection Each vial contains 8 000 units (40 mg) tenecteplase. Each pre-filled syringe contains 8 mL solvent. Metalyse 10 000 units (50 mg) powder and solvent for solution for injection Each vial contains 10 000 units (50 mg) tenecteplase. Each pre-filled syringe contains 10 mL solvent. The reconstituted solution contains 1 000 units (5 mg) tenecteplase per mL. Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents. Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white to off-white. The solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use. Treatment with Metalyse should be initiated as early as possible after onset of symptoms. The appropriate presentation of tenecteplase product should be chosen carefully and in line with the indication. The 40 mg and 50 mg presentations are only intended for use in acute myocardial infarction. 3 Metalyse should be administered on the basis of body weight, קרא את המסמך השלם