Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
etonogestrel, ethinylestradiol
N.V. Organon
G02BB01
etonogestrel, ethinylestradiol
11,7mg+ 2,7mg
vaginal delivery system (vaginal ring)
(1) sachet
Prescription
Registered
2019-12-03
S UMMARY OF P RODUCT C HARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT NuvaRing® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ring contains: active ingredients: 11.7 mg etonogestrel and 2.7 mg ethinylestradiol; excipients: ethylene vinylacetate copolymer [28% vinylacetate]; ethylene vinylacetate copolymer [9% vinylacetate]; magnesium stearate. The ring releases 0.120 mg of etonogestrel/ 0.015 mg of ethinylestradiol per day. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal ring, 0.120 mg etonogestrel /0.015 mg ethinylestradiol for day. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception. NuvaRing is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to 40 years. The decision to prescribe NuvaRing should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with NuvaRing compares with other combined hormonal contraceptives (see sections “Contraindications” and “Precautions”). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ To achieve contraceptive effectiveness, NuvaRing must be used as directed in subsections “How to use NuvaRing” and “How to start NuvaRing”. _Paediatric population _ The safety and efficacy of NuvaRing in adolescents under the age of 18 have not been studied. HOW TO USE NUVARING The woman herself can insert NuvaRing in the vagina. The physician should advise the woman how to insert and remove NuvaRing. For insertion of the ring the woman should choose a position that is most comfortable for her, e.g. standing with one leg up, squatting, or lying down. NuvaRing should be compressed and inserted into the vagina until it feels comfortable. The exact position of NuvaRing ring in the vagina is not critical for the contraceptive effect (see Figures 1-4). Once NuvaRing has been inserted (see “How to start NuvaRing”) it is left in the vagina continuously for 3 weeks. Advise women to regularly c Прочитать полный документ