Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
clopidogrel hydrogen sulfate
Sanofi-Aventis Australia Pty Ltd
clopidogrel hydrogen sulfate
Registered
plavix-ccdsv27-piv-20-06jan21 1 AUSTRALIAN PRODUCT INFORMATION – PLAVIX ® (CLOPIDOGREL HYDROGEN SULFATE) FILM COATED TABLET 1 NAME OF THE MEDICINE Clopidogrel hydrogen sulfate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Plavix 75 mg contains 97.875 mg of clopidogrel hydrogen sulfate which is the molar equivalent of 75 mg of clopidogrel base. Plavix 300 mg contains 391.5 mg of clopidogrel hydrogen sulfate which is the molar equivalent of 300 mg of clopidogrel base. Excipient with known effect: the coating contains lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 75 mg film coated tablets - pink round slightly biconvex film coated tablets, engraved “75” on one side and “1171” on the other side. 300 mg film coated tablets - pink oblong film coated tablets, engraved “300” on one side and “1332” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ACUTE CORONARY SYNDROME Plavix is indicated in combination with aspirin for patients with: • Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Plavix is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent). • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Plavix has been shown to reduce the rate plavix-ccdsv27-piv-20-06jan21 2 of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION Clopidogrel should be taken once a day with or without food. Lire le document complet