Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clopidogrel
Sandoz Ltd
B01AC04
Clopidogrel
75mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02090000; GTIN: 5050650062038
CLOPIDOGREL 75 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 05-Jan-2015 | Sandoz Limited 1. Name of the medicinal product Clopidogrel 75 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel hydrochloride). Excipients with known effect: Each film-coated tablet contains 7.50 mg of hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Pink colored, film-coated, round shaped tablets, plain on both sides. 4. Clinical particulars 4.1 Therapeutic indications _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 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 section 5.1. 4.2 Posology and method of administration Posology • Adults and older people Clopidogrel should be given as a single daily dose of 75 mg. In patients suffering from acute coronary syndrome: − Non-ST segment elevation acute coronary syndro Przeczytaj cały dokument