Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clopidogrel (clopidogrel hydrogen sulphate)
KRKA
B01AC04
clopidogrel (clopidogrel hydrogen sulphate)
75mg
tablets film-coated
(14/2x7/) in blister, (28/4x7/) in blister
Prescription
Registered
2023-11-25
1 1. NAME OF THE MEDICINAL PRODUCT Zyllt ® 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose and 4 mg hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round, pink, slightly biconvex film-coated tablets. 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), ischemic 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Read the complete document