Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
eplerenone
Pfizer PGM
eplerenone
25mg
tablets film-coated
Prescription
"r ,,r;lr::.t::;...r1i,.:*:*i',,;*r:rri;.i':.i;;t:!l:::::':;.::::rL.': :::.: r:;. 'a't n-. / X j jt-)iilg i3 ry IN8 1 INSPRA UK APPROVED SUMMAR\' OF PRODUCT CHARACIITBRISTICS 1. NAME OF THE MEDICINAL PRODUCT INSPRA'r$ 25 urg film-coated tablets. INSPRA€' 50 nrg fi lm-coated tablets. 2. QUALI.TATIVE AND QUANTITATIVE COMPOSITION Each tablet contzrins 25 mg of eplerenone. Each tablet contains 50 mg of eplerenone. Excipients: Each 25mg tablet ooutains 35.7nrg of lactose monohydrate (see section 4.4). Each 50rng,tablet contains 71.4mg of I'actose monohydrate (see section 4'4). For a full list of excipients see section 6.1 . 3. PHARMACIUTTCAL FORM Fihr-coated tablet. ?5 nrg tablet: yellow tatrlet u,ith stylized "Pfizer" on one side of tablet, "NSI{" over "25"on the other side of tablet. 50 mg tablet; yellow tablet with stytized "Pfizer" on one side of tablet, "NSR" over "50"on the other side of tablet. 4. CLINICAL I]ARTICULAJTS I- . 4.1. Therapeutic itrtlications Eplerenone is inclicated: r in zrdclition to standarcl tlielapy incluclingbeta-blockers, to redttce tlre risk of cardiovascu'lar rnortalitl, ancl n"rorbiclity in stable patients with lefl verrtricr-rlar dysfunction (LVEF S 4A %) apcl clirrical evidence of heart failure after recent uryocardial iufarction. . in adclition to standard optir,ral therapy, to recluce tlie risk of cardiovascular mortality and rnorbiclity in aclLrlt patients with NYIIA class ll (chrorric) hcart failure and left verrtricular systolic clysfunction (LVEF -30%) (see section 5.1). 4.2. Posology ancl Methocl of Atlministratiott For the indivicluat acljr.rstment of dose, the strengths of 25 mg and 50 nlg are available.'l'he maximum dose regimen is 50 rrrg daily. .:1?,rrr!!1:ili{ ;s*,'{r{ ${ {t{iiji! $!1f l*ttu*ii ?(eHg&l{G? ln\SPRA 25 nrg and 50 mg filrn-coated tablets r:tdit, *A$:qlg,i'Y*+a s rSS INSPRA UK APPROVED IN 8-I F or' 1s a s t - ntlt o c ar d i ul in/ a r c t i o rt he ar t fa i I ur e p a t ie n ts : The-recomnenclecl maintenarrce dose of eplerenoue is 50 rng once daily (OD). T Baca dokumen lengkap