País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CLOPIDOGREL HYDROGEN SULFATE
AVENTIS PHARMA - Indonesia
CLOPIDOGREL HYDROGEN SULFATE
391.5 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT
SANOFI WINTHROP INDUSTRIE - France
2022-01-21
ID REG: EREG10002212200251, 253 DISETUJUI OLEH BPOM 13 JANUARI 2023 Plavix CCDS Update V30 1 of 22 PLAVIX CLOPIDOGREL COMPOSITION PLAVIX 75 MG FILM-COATED TABLET Each film-coated tablet contains 97.875 mg of Clopidogrel hydrogen sulphate form II (molar equivalent of 75 mg of Clopidogrel base). PLAVIX 300 MG FILM-COATED TABLET Each film-coated tablet contains 391.5 mg of Clopidogrel hydrogen sulphate form II (molar equivalent of 300 mg of Clopidogrel base). PHARMACEUTICAL FORM PLAVIX 75 MG FILM-COATED TABLET Film-coated tablet: pink, round, biconvex, engraved with <<75>> on one side and <<1171>> on the other side. PLAVIX 300 MG FILM-COATED TABLET Film-coated tablet: pink, oblong, engraved with <<300>> on one side and <<1332>> on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Clopidogrel is indicated for the secondary prevention of atherothrombotic events in: • 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. • 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 score ≥4) or minor IS (NIHSS ≤3) within 24 hours of either the TIA or IS event. For further information please refer to “_Pharmacodynamic properties_”. POSOLOGY AND METHOD OF ADMINISTRATION • Adults and elderly This 300 mg tablet of clopidogrel is intended for use as a loading dose in patients suffer Leer el documento completo