国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ulipristal (ulipristal acetate)
Laboratorios Leon Farma S.A.
G03AD02
ulipristal (ulipristal acetate)
30mg
tablets
(1) in blister
OTC
Registered
2018-05-07
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dvella 30 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg ulipristal acetate. Excipients with known effect: Each tablet contains 237 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White to marble creamy, round curved tablet of 9mm diameter engraved with _“еllа”_ on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. Dvella can be taken at any time during the menstrual cycle. If vomiting occurs within 3 hours of Dvella intake, another tablet should be taken. If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before Dvella is administered. Special populations _ _ _Renal impairment_ No dose adjustment is necessary. _Hepatic impairment _ In the absence of specific studies, no alternate dose recommendations for Dvella can be made. _Severe hepatic impairment_ In the absence of specific studies, Dvella is not recommended. _Paediatric population _ There is no relevant use of Dvella for children of prepubertal age in the indication emergency contraception _._ Adolescents: Dvella is suitable for any woman of child bearing age, including adolescents. No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1). 3 Method of administration Oral use. The tablet can be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dvella is for occasional use only. It should in no insta 完全なドキュメントを読む