药品信息:
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详细处方信息以本药内容附件PDF文件（201411400430220.pdf）的“原文Priscribing Information”为准
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部分中文OSPHENA处方资料（仅供参考）
1. 适应证和用途
OSPHENA适用于中度至严重性交痛的治疗，一种由于绝经外阴和阴道萎缩的症状。
2. 剂量和给药方法
OSPHENA是一种雌激素激动剂/拮抗剂对子宫内膜有激动作用。一般说来，当产品对子宫内膜有雌激素激动作用，为有子宫绝经后妇女处方，应考虑孕激素以减低子宫内膜癌的风险。没有子宫妇女不需要孕激素[见警告和注意事项(5.2)]。
OSPHENA的使用应是符合各妇女治疗目的和风险的最短时间。绝经后妇女应定期重新评价确定临床上是否仍需要治疗
2.1 中度至严重性交痛的治疗，一种由于绝经外阴和阴道萎缩的症状
与食物服用60 mg片每天1次。
3. 剂型和规格
OSPHENA片白色至类白色，椭圆形，双凸，薄膜包衣片含60 mg的ospemifene和一侧刻有“60”。
4. 禁忌证
有以下任何一种条件下妇女中禁忌用OSPHENA：
● 未确诊的生殖器异常出血
● 已知或怀疑雌激素-依赖性肿瘤
● 活动性DVT，肺栓塞(PE)，或这些情况史
● 活动性动脉血栓栓塞病[例如，卒中和心肌梗死(MI)]，或这些情况病史
● 妊娠或可能成为妊娠妇女禁忌使用OSPHENA。当给予妊娠妇女时OSPHENA可能致胎儿危害。有分娩困难时Ospemifene使胚胎-胎儿致死和在大鼠中在剂量低于临床暴露水平增加幼畜死亡，而在兔中根据体表面积mg/m2剂量为临床暴露的10倍时胚胎-胎儿致死。如果在妊娠期间使用此药，或如妇女服用此药时成为妊娠，应忠告她对胎儿的潜在危害。
5. 警告和注意事项
5.1 心血管疾病
对心血管疾病，动脉血管病(例如，高血压，糖尿病，吸烟，高胆固醇血症，和肥胖)和/或静脉血栓栓塞病(VTE)风险因子(例如，VTE，肥胖，和系统性红斑狼疮个人病史或家庭史)，应适当处理。.
在妇女健康倡议(WHI)单独雌激素子研究中，报道在妇女50至79岁每天单独接受结合雌激素(0.625 mg)与相同年龄组接受安慰剂妇女比较(45相比较33每一万妇女-年)卒中风险统计显著的增加。证实在第1年风险增加和持续。
在对OSPHENA临床试验中(治疗时间达15个月)，OSPHENA 60 mg治疗组血栓栓塞和出血性卒中的发生率分别为每一千妇女0.72和1.45，而安慰剂每一千妇女为1.04和0。
发生或怀疑血栓栓塞或出血性卒中，应立即终止OSPHENA。
Osphena (ospemifene) works like estrogen in the lining of the uterus, but can work differently in other parts of the body.
Taking estrogen alone or Osphena may increase your chance for getting cancer of the lining of the uterus, strokes, and blood clots. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell them right away if this happens while you are using Osphena.
You and your healthcare provider should talk regularly about whether you still need treatment with Osphena.
Call your healthcare provider right away if you get changes in vision or speech, sudden new severe headaches, and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue. Osphena should not be used if you have unusual vaginal bleeding; have or have had certain types of cancers (including cancer of the breast or uterus); have or had blood clots; had a stroke or heart attack; have severe liver problems; or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.
Possible side effects
Serious but less common side effects can include stroke, blood clots, and cancer of the lining of the uterus.
Common side effects can include hot flashes, vaginal discharge, muscle spasms and increased sweating.
Tell your healthcare provider about all of the medicines you take as some medicines may affect how Osphena works. Osphena may also affect how other medicines work. |
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