국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
prasugrel
Substipharm
B01AC22
prasugrel
Antithrombotic agents
Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Revision: 25
Authorised
2009-02-24
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER EFIENT 10 MG FILM-COATED TABLETS EFIENT 5 MG FILM-COATED TABLETS prasugrel 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, ask your doctor or pharmacist. - 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. WHAT IS IN THIS LEAFLET_ _ 1. What Efient is and what it is used for 2. What you need to know before you take Efient 3. How to take Efient 4. Possible side effects 5. How to store Efient 6. Contents of the pack and other information 1. WHAT EFIENT IS AND WHAT IT IS USED FOR Efient, which contains the active substance prasugrel, belongs to a group of medicines called anti- platelet agents. Platelets are very small cell particles that circulate in the blood. When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death. Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain). Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming. You have been prescribed Efient because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart. You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart. Efient redu 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Efient 10 mg film-coated tablets. Efient 5 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Efient 10 mg: _ Each tablet contains 10 mg prasugrel (as hydrochloride). Excipient(s) with known effect Each tablet contains 2.1 mg lactose monohydrate. _ _ _Efient 5 mg: _ Each tablet contains 5 mg prasugrel (as hydrochloride). Excipient(s) with known effect Each tablet contains 2.7 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). _Efient 10 mg: _ Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other. _ _ _ _ _Efient 5 mg: _ Yellow and double-arrow shaped tablets, debossed with “5 MG” on one side and “4760” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS_ _ Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). For further information please refer to section 5.1. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION_ _ Posology _Adults _ Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1). Patients taking Efient should also take ASA daily (75 mg to 325 mg). 3 In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’s underlying disease. A treatment of up to 12 전체 문서 읽기