Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
clopidogrel (as hydrogen sulfate)
Teva B.V.
B01AC04
clopidogrel
Antithrombotic agents
Myocardial Infarction; Acute Coronary Syndrome; Peripheral Vascular Diseases; Stroke
Secondary prevention of atherothrombotic 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 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.Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn 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.
Revision: 14
Authorised
2015-02-18
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel ratiopharm 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate). Excipient with known effect: Each film-coated tablet contains 59.05 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic 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 bleedi Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel ratiopharm 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate). Excipient with known effect: Each film-coated tablet contains 59.05 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic 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 bleedi Прочетете целия документ