Страна: Израиль
Язык: английский
Источник: Ministry of Health
CLOPIDOGREL AS HYDROGEN SULFATE
SANOFI ISRAEL LTD
B01AC04
FILM COATED TABLETS
CLOPIDOGREL AS HYDROGEN SULFATE 75 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
CLOPIDOGREL
CLOPIDOGREL
Secondary Prevention of atherotrobmotic eventsClopidogrel is indicated in :• Adult Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic 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/non-Q-wave myocardial infarction (MI)), 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 therapyPrevention of atherotrobmotic 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 the treatment with Vitamin K antagonists (VKA) Anti-Thrombin or Anti Factor Xa, and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
2023-04-30
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only PLAVIX 75 MG film-coated tablets ACTIVE INGREDIENT Each Plavix 75 mg tablet contains: clopidogrel (as hydrogen sulfate) 75 mg For information about inactive ingredients and allergens in the medicine, see section 2 under “Important information about some of the medicine’s ingredients” and section 6 “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is intended for secondary prevention of atherothrombotic vascular events (heart attacks, cerebral stroke or vascular death) in patients with atherosclerosis who had a myocardial infarction, ischemic cerebrovascular event, or who suffer from peripheral arterial disease, and in patients suffering from unstable angina pectoris, including patients undergoing implant of a stent by catheterization and who are being treated with aspirin. The medicine is intended for prevention of atherothrombotic and thromboembolic events (heart attacks, cerebral stroke, emboli or vascular death) in combination with aspirin, in patients suffering from heart rhythm disorder such as atrial fibrillation, who are not suitable for treatment with anti-coagulants of the vitamin K antagonist type such as warfarin (Coumadin), anti-thrombin or anti-factor Xa. THERAPEUTIC GROUP: Platelet aggregation inhibitors, from the thienopyridine group. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: - you are sensitive (allergic) to clopidogrel or to any of the other ingredients of this medicine (see section 6). - you suffer from a medical condition that is c Прочитать полный документ
1 _Plavix-SPC-22.0 _ 1. NAME OF THE MEDICINAL PRODUCT Plavix 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Plavix 75mg Each film-coated tablet contains 75mg of Clopidogrel (as hydrogen sulphate). _Excipients with known effect:_ Each film-coated tablet contains 3 mg lactose and 3.3 mg hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Plavix 75 mg film-coated tablets are 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 atherotrombotic events _ Clopidogrel is indicated in: • Adult Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic 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/non-Q-wave myocardial infarction (MI)), 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 _Prevention of atherothrobmotic 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 the treatment with Vitamin K antagonists (VKA) Anti-Thrombin or Anti Factor Xa , 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 section 5.1. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology • Adults and elderly Plavix 75 mg film-coated tablets Clopidogrel should be given as a single daily dose of 75 mg. In patients suffering from acute coronary syn Прочитать полный документ