国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Etonogestrel; Ethinylestradiol
Organon Pharma (UK) Ltd
Etonogestrel; Ethinylestradiol
11.7mg ; 2.7mg
Vaginal delivery system
Vaginal
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030101; GTIN: 5012376032337
PACKAGE LEAFLET: INFORMATION FOR THE USER NUVARING®, 0.120 MG/0.015 MG PER 24 HOURS, VAGINAL DELIVERY SYSTEM ETONOGESTREL/ETHINYLESTRADIOL 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. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them. • 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. WHAT IS IN THIS LEAFLET 1. What NuvaRing is and what it is used for 2. What you need to know before you use NuvaRing 2.1 When you should not use NuvaRing 2.2 Warnings and precautions Blood clots _ _ Cancer 2.3 Children and adolescents 2.4 Other medicines and NuvaRing Laboratory tests 2.5 Pregnancy and breast-feeding 2.6 Driving and using machines 3. How to use NuvaRing 3.1 How to insert and remove NuvaRing 3.2 Three weeks in, one week out 3.3 When to start with the first ring 3.4 What to do if… Your ring is accidentally expelled from the vagina Your ring has temporarily been out of the vagina Your ring breaks You have inserted more than one ring You have forgotten to insert a new ring after the ring-free interval You have forgotten to remove the ring You have missed a menstrual period You have unexpected bleeding You want to change the first day of your menstrual period You want to delay your menstrual p 完全なドキュメントを読む
OBJECT 1 NUVARING Summary of Product Characteristics Updated 17-Jan-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product NuvaRing®, 0.120 mg/0.015 mg per 24 hours, vaginal delivery system 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 delivery system. 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. 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 (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. An optional alternative is to insert the ring using the NuvaRing Applicator which is distributed separately or is included in the package. The NuvaRing Appl 完全なドキュメントを読む