Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
ETHINYLESTRADIOL; ETONOGESTREL
ORGANON PHARMA ISRAEL LTD., ISRAEL
G03CA01
VAGINAL RING
ETHINYLESTRADIOL 2.7 MG; ETONOGESTREL 11.7 MG
VAGINAL
Required
ORGANON LLC, USA
ETHINYLESTRADIOL
ETHINYLESTRADIOL
Contraception. The safety and efficacy has been established in women aged 18 to 40 years.
2014-11-30
[Organon] Proprietary PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only NUVARING ® VAGINAL RING COMPOSITION: Active ingredients and quantity: Etonogestrel 11.7 mg Ethinylestradiol 2.7 mg Etonogestrel and ethinylestradiol are released from the ring at a rate of 0.120 mg/day and 0.015 mg/day, each for 3 weeks. For a list of inactive ingredients see section 6.1 "WHAT NUVARING CONTAINS". IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): • They are one of the most reliable reversible methods of contraception if used correctly. • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks. • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2, “BLOOD CLOTS”). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING NUVARING BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • This leaflet contains concise information about NUVARING. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4, “SIDE EFFECTS”). 1. WHAT NUVARING IS INTENDED FOR? THERAPEUTIC GROUP: a contraceptive vaginal ring that contains estrogen and a progestagen. NUVARING is a contraceptive vaginal ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. The ring slowly releases these hormones into the blood circulation. Because of Leggi il documento completo
1. NAME OF THE MEDICINAL PRODUCT NuvaRing ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NuvaRing contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal ring NuvaRing is flexible, transparent, and colourless to almost colourless ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception. 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 (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To achieve contraceptive effectiveness, NuvaRing must be used as directed (see ‘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. Method of administration 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 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 in the vagina is not critical for the contraceptive effect of the ring (_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 check for the presence of NuvaRing in the vagina (for example, before and after intercourse). Leggi il documento completo