Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
Clopidogrel bisulphate 97.875mg eqv Clopidogrel
SANDOZ SINGAPORE PTE. LTD.
B01AC04
75mg
TABLET, FILM COATED
Clopidogrel bisulphate 97.875mg eqv Clopidogrel 75mg
ORAL
Prescription Only
Sandoz Private Limited
ACTIVE
2009-12-14
CLOPIDOGREL SANDOZ FILM COATED TABLET 75MG 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz Film Coated Tablet 75 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains: Clopidogrel (as hydrogen sulphate 97.875 mg) 75.00 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. Pink colored, round shaped, engraved with ‘SZ’ 75 on one side and plain on 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), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: o 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). o 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. 1 Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis 2 National Institutes of Health Stroke Scale _PREVENTION OF ATHEROTHROMBOTIC AND THROMBOEMBOLIC EVENTS IN ATRIAL FIBRILLATION _ In adult patients with atrial fibrillation (AF) 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, inclu Perskaitykite visą dokumentą