| —Annovera（醋酸庚酯和乙炔雌二醇[segesterone acetate and ethinyl estradiol vaginal system]）阴道系统-为全球第一种也是唯一一种避孕新药 2018年8月10日，美国食品和药物管理局（FDA）批准Annovera（醋酸硒醋酸酯和乙炔雌二醇[segesterone acetate and ethinyl estradiol vaginal system]）阴道系统，这是第一种也是唯一一种在完全受女性控制的情况下提供全年保护以防止意外怀孕的避孕药。该批准是给扩大妇女避孕新选择。 关于Annovera Annovera是一种阴道避孕系统。Annovera将一种新的孕激素（醋酸硒酯）与广泛使用的雌激素（乙炔雌二醇）结合成一个可重复使用的环。Annovera插入阴道，必须留在原处28天。 Annovera尚未在体重指数（BMI）大于29kg/m2的女性中得到充分评估。 最常见的副作用是头痛和恶心。与其他联合激素避孕药类似，Annovera有关于吸烟和严重心血管事件的盒装警告。35岁以上的女性吸烟的人不应该使用Annovera。任何年龄的吸烟都会增加使用激素避孕药的严重心血管事件的风险 避孕环在不使用时洗涤并储存在紧凑的盒子中7天。Annovera在分配前不需要冷藏，可以承受高达30°C（86°F）的储存温度。 Annovera(segesterone acetate and ethinyl estradiol vaginal system) Indications ANNOVERA™ is indicated for use by females of reproductive potential to prevent pregnancy. Limitation Of Use ANNOVERA™ has not been adequately studied in females with a BMI >29 kg/m2. How supplied Dosage Forms And Strengths Vaginal system: Each ANNOVERA™ releases an approximate average 0.15 mg/day of segesterone acetate (SA) and 0.013 mg/day of ethinyl estradiol (EE) when placed in the vagina over a period of 21 days of each cycle for up to 13 cycles (total of 273 days). Each cycle of use is 28 days with 21 days in and 7 days out. ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal-shaped (ring), nonbiodegradable, flexible, opaque white, contraceptive vaginal system containing 103 mg of SA and 17.4 mg EE. ANNOVERA™ is 56 mm in overall diameter and 8.4 mm in cross-sectional diameter. It contains 2 channels of approximately 3.0 mm diameter and 27 mm length into which steroid-containing cores are inserted. The cores are 3 mm in diameter with one releasing SA alone and the other releasing both SA and EE. Each ANNOVERA™ is designed to be used for up to 13 cycles (1 year). ANNOVERA™ is not made with natural rubber latex. Storage And Handling ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal-shaped (ring), nonbiodegradable, flexible, opaque white vaginal system. The vaginal system body has an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm. When placed inside the vagina, each ANNOVERA™ releases an approximate average 0.15mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol over 21-day in-use period of each cycle for up to 13 cycles (total 273 days). Each cycle is 28 days, with 21 days in and 7 days out. Each ANNOVERA™ is individually packaged in an aluminum pouch. The pouch consists of a laminate from outside to inside of polyester, aluminum foil, and polyethylene. A black compact case is provided with the drug product for storage of ANNOVERA™ by patients during each 7-day vaginal system-out interval. The vaginal system should be placed in the compact case after 13 cycles of use and discarded via a drug take-back option if one is available. If a take-back option is unavailable, then discard in the waste receptacle out of reach of children and pets. The vaginal system should NOT be flushed down the toilet. See www.fda.gov/drugdisposal for more information about disposal of medicines. Each box contains 1 pouch. NDC 72468-313-01 Storage Conditions Prior to dispensing ANNOVERA™ to the user, store ANNOVERA™ at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. Protect ANNOVERA™ from direct sunlight. Do not refrigerate or freeze, and avoid excessive heat. Manufactured for: Population Council One Dag Hammarskjold Plaza New York, NY 10017 United States. Revised: Aug 2018 Overdose There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. In case of suspected overdose, all ANNOVERA™ vaginal systems should be removed and symptomatic treatment given. Patient information Annovera™ (ann-o-VER-ah) (segesterone acetate and ethinyl estradiol vaginal system) Read this Patient Information carefully before you decide if Annovera™ is right for you. This information does not take the place of talking with your gynecologist or other health-care provider who specializes in women’s health. If you have any questions about Annovera™, ask your health-care provider. You should also learn about other birth control methods to choose the one that is best for you. What is the most important information I should know about Annovera™? Do not use Annovera™ if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke. Annovera™does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). What is Annovera™? Annovera™ is a hormone-releasing system used by females who are able to become pregnant to prevent pregnancy. You insert Annovera™ into your vagina. Annovera™ is in the shape of a ring that is reusable for 1 year. The vaginal system is made of silicone and contains two female hormones that are slowly released into your vagina and then enter your blood. One hormone is an estrogen called ethinyl estradiol. The other hormone is a progestin called segesterone acetate. How well does Annovera™ work for contraception? Your chance of getting pregnant depends on how well you follow the directions for using the vaginal system. The more carefully you follow the directions, the less chance you have of getting pregnant. Based on the results of two clinical studies that lasted 12 months, about 2 to 4 women out of 100 women may get pregnant during the first year they use Annovera™. Annovera™ was designed to be reused for 1 year. Replace Annovera™ at the end of 1 year if you choose to continue using Annovera™. There is not enough hormone left in the vaginal system to provide you effective birth control after 1 year of use. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in how well they work to prevent pregnancy. The most effective methods are at the top of the chart. The box at the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. https://www.prnewswire.com/news-releases/fda-approves-the-first-one-year-contraceptive-fully-under-a-womans-control-300695566.html |
美国FDA批准Annovera为新类防止意外怀孕的避孕药简介：
Annovera（醋酸庚酯和乙炔雌二醇[segesterone acetate and ethinyl estradiol vaginal system]）阴道系统-为全球第一种也是唯一一种避孕新药2018年8月10日，美国食品和药物管理局（FDA）批准Annovera（醋 ... 责任编辑：p53
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