País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ulipristal (ulipristal acetate)
Gedeon Richter PLC
G03XB02
ulipristal (ulipristal acetate)
5mg
tablets
(28/2x14/) in blister, (84/6x14/) in blister
Prescription
Registered
2018-12-13
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ESMYA® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5.00 mg of ulipristal acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, round biconvex tablet , engraved with “ES5” on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids. Posology The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each. Tablets may be taken with or without food. Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation. - Re-treatment courses should start at the earliest during the first week of the second menstruation_ _ following the previous treatment course completion. The treating physician should explain to the patient the requirement for treatment free intervals. Repeated intermittent treatment has been studied up to 4 intermittent courses. If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. _Special population_ _Renal impairment _ No dose adjustment is recommended in patients with mild or moderate renal impairment. In the absence of specific studies, ulipristal acetate is not recommended in patients with severe renal impairment unless the patient is cl Leia o documento completo