Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clopidogrel (clopidogrel bisulfate)
A LAB PHARMACEUTICALS LLC
B01AC04
clopidogrel (clopidogrel bisulfate)
75mg
tablets film-coated
(20/2x10/) in blister
Prescription
Registered
2022-09-23
SUMMARY OF PRODUCT CHARACTERISTICS CLOPIDOL CLOPIDOGREL BISULFATE 75 MG FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT CLOPIDOL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains _Active substance_: clopidogrel (as clopidogrel bisulfate) 75 mg _Excipients:_ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light brown, circular, slightly biconvex film-coated tablets, plain on both sides. 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: - 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 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 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. 1 Age, Blood pressure, Clinical feature Read the complete document