País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ulipristal (ulipristal acetate)
Gedeon Richter PLC
ulipristal (ulipristal acetate)
5mg
tablets
Prescription
1. NAME OF TIID MEDICINAL PRODUCT Esmya 5 mg tablets 2, QUALITATM AND QUANTIT.{TrVE COMPOSTTION Each tablet contains 5 mg ofulipristal acetate. For the full list of excipieLrts, see sec.tion 6. I . 3. PHARMACEUTICAL FORM Tablet. write to otr-white. rouncl biconvex tablet of ? mnr engravecl with ,,8S5" on one face. 4, CLINICAL PARTICULARS 4,1 Therapeuticindications Ulipristal acetate is indicated for pre-opemtive treatment of moclerate to severe symptoms of uterine .fibroids in adult women of reproductive age. Uliplistal acalate is indicatecl for interrnittent treatnlent of modelate to severe sympl-or:rs of uterine fibloicls in adult women of reprocfi.rctive age. 4,2 Posology and rnethod of administration Posology The treatment consists of one tablet of 5 mg to be taken orally once claily for treatment courses of up. to 3 monthg each. Treatments should only be initiated when menstruation has occurred: - The first tleatment course should start during the first week of meustruation. - Re-treatment cottrses should start at the earliest during the first weelc of the secolcl menstruation fol treatment cortrse completiou. Th slrotrld explain to the patient the requiremert for treatment free interva.ls. Re reatment l-ras been stucried up to 4 intermittent courses. Ila patient misses a dose, the patient should take ulipristal acetate as sooll as possibJe, If the dose was missed by more tl"tan 12 hout's, the patient should noi take the missecl close and simply resume the usual dosing schedule. Special pznulqtion Renal inzpairment No dose adjustment is reconlmendecl in patients rvith mild or rnoclerate lenal impalr.ment. In the absence of specitic studies, ulipristal acetate is not recornrrrencled in patients with severe relal irnpairnerrt unless the patient is cJosely monitorecl (see sectiorrs 4.4 ancl 5.2). Hepatic impairment No dose adjustment is rgcotntneuded foL patients with mild hepatic impairment, In the absence of specific studies, uliplistal acetate is uot Lecomnrended in patients with modelate or severe hepatic 3 Leia o documento completo