Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
losartan (losartan potassium)
Gedeon Richter PLC
C09CA01
losartan (losartan potassium)
100mg
tablets film-coated
(10/1x10/) in blister, (30/3x10/) in blister
Prescription
Registered
2019-03-13
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SENTOR ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: _Active substances: _ Film-coated tablets, 50 mg: losartan potassium - 50 mg; Film-coated tablets, 100 mg: losartan potassium - 100 mg. Excipients with known effect: _ _ _Film-coated tablets, 50 mg:_ Each film-coated tablet contains 1.050 mg of lactose monohydrate. _Film-coated tablets, 100 mg:_ Each film-coated tablet contains 2.10 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. _Film-coated tablets, 50 mg: _ Round, biconvex, film-coated tablets of white or almost white colour, with break-line on one side and engraving "50" on the other. The tablets can be divided into equal doses. _Film-coated tablets, 100 mg: _ Oval, biconvex, film-coated tablets of white or almost white colour, with engraving "100" on one side, the other side is without sign. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age. - Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment. - Treatment of chronic heart failure in adult patients when treatment with angiotensin converting enzyme (ACE) inhibitors is not considered suitable due to intolerance, _especially cough_, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤40% and should be clinically stable and on an established treatment regimen for chronic heart failure. - Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypertension _ The usual starting and maintenance Olvassa el a teljes dokumentumot