Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOPIDOGREL
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
CLOPIDOGREL
14Tablet Tablets
SANOFI WINTHROP INDUSTRIE
_ _ _MY/PLA/0622/CCDSv29,30 _ _ _ _ _ _ _ _ _ _1 _ _ _ _Consumer Medication Information Leaflet (RiMUP)_ PLAVIX ® _ _ TABLET _ _ Clopidogrel 75mg & 300mg _ _ WHAT IS IN THIS LEAFLET 1. What Plavix is used for 2. How Plavix works 3. Before you use Plavix 4. How to use Plavix 5. While you are using it 6. Side effects 7. Storage and Disposal of Plavix 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PLAVIX IS USED FOR Plavix is taken by adult to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death). You have been prescribed Plavix to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You mayalso be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor. - You have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or an ischemic stroke mild in severity. You may also be given acetylsalicylic acid by your doctor starting within the first 24 hours. - You have an irregular heartbeat, a condition called 'atrial fibrillation', and you cannot take medicines known as 'oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that 'oral anticoagulants' are more effective than acetylsalicylic aci Izlasiet visu dokumentu
MY/PLA75/0622/CCDSv29, 30 1. NAME OF THE MEDICINAL PRODUCT Plavix 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). Excipients with known effect: each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _SECONDARY PREVENTION OF ATHEROTHROMBOTIC EVENTS _ Clopidogrel is indicated in: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. • Adult patients suffering from acute coronary syndrome: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). − ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. _IN PATIENTS WITH MODERATE TO HIGH-RISK_ _TRANSIENT ISCHEMIC ATTACK (TIA) OR MINOR ISCHEMIC STROKE (IS) _ Clopidogrel in combination with ASA is indicated in: - Adult patients with moderate to high-risk TIA (ABCD2 1 score ≥4) or minor IS (NIHSS 2 ≤3) within 24 hours of either the TIA or IS event. _PREVENTION OF ATHEROTHROMBOTIC AND THROMBOEMBOLIC EVENTS IN ATRIAL FIBRILLATION _ In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to s Izlasiet visu dokumentu