奥培米芬片 osphena (ospemifene) fda药品说明书翻译

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1、FULLPRESCRIBINGINFORMATIONWARNING:ENDOMETRIALCANCERANDCARDIOVASCULARDISORDERS警告：子宫内膜癌和心血管疾病EndometrialCancer子宫内膜癌OSPHENAisanestrogenagonist/antagonistwithtissueselectiveeffects.Intheendometrium,OSPHENAhasestrogenagonisticeffects.Thereisanincreasedriskofendometr

2、ialcancerinawomanwithauteruswhousesunopposedestrogens.Addingaprogestintoestrogentherapyreducestheriskofendometrialhyperplasia,whichmaybeaprecursortoendometrialcancer.Adequatediagnosticmeasures,includingdirectedandrandomendometrialsamplingwhenindicated,shouldbeu

3、ndertakentoruleoutmalignancyinpostmenopausalwomenwithundiagnosedpersistentorrecurringabnormalgenitalbleeding[seeWarningsandPrecautions(5.2)].本药是一种具有组织选择性作用的雌激素激动药和拮抗药。在子宫内膜中，具有雌激素激动作用。使用非对抗性雌激素的女性(有子宫)患子宫内膜癌的风险增加。雌激素治疗时合用孕激素可降低子宫内膜增生的风险，而子宫内膜增生可能是子宫内膜癌的先兆。未经确诊的

4、持续或复发性生殖器异常出血的绝经后妇女应采取适当的诊断措施以排除恶性肿瘤，包括定向和随机的子宫内膜取样。CardiovascularDisorders心血管疾病Thereisareportedincreasedriskofstrokeanddeepveinthrombosis(DVT)inpostmenopausalwomen(50to79yearsofage)whoreceiveddailyoralconjugatedestrogens(CE)[0.625mg]-alonetherapyover7.1yearsas

5、partoftheWomen’sHealthInitiative(WHI)[seeWarningsandPrecautions(5.1)].有绝经后妇女(50-79岁)，遵从妇女健康倡议(WHI)每日接受口服结合雌激素(CE，0.625mg)单药治疗7.1年，卒中和深静脉血栓形成(DVT)风险增加的报道。IntheclinicaltrialsforOSPHENA(durationoftreatmentupto15months),theincidenceratesofthromboembolicandhemorrhag

6、icstrokewere0.72and1.45perthousandwomen,respectivelyinOSPHENA60mgtreatmentgroupand1.04and0inplacebo[seeWarningsandPrecautions(5.1)].TheincidenceofDVTwas1.45perthousandwomeninOSPHENA60mgtreatmentgroupand1.04perthousandwomeninplacebo[seeWarningsandPrecautions(5.1

7、)].OSPHENAshouldbeprescribedfortheshortestdurationconsistentwithtreatmentgoalsandrisksfortheindividualwoman.临床试验(治疗时间达15个月，受试者为女性)中，本药60mg治疗组血栓栓塞性卒中和出血性卒中的发生率分别为0.72‰和1.45‰，安慰剂组为1.04‰和0‰；本药60mg治疗组DVT发生率为1.45‰，安慰剂组为1.04‰。本药处方应以最短的治疗时间满足治疗目的和风险。1INDICATIONSANDUSA

8、GE适应症和用途OSPHENAisindicatedforthetreatmentofmoderatetoseveredyspareunia,asymptomofvulvarandvaginalatrophy,duetomenopause.用于治疗中至重度性交困难，以缓解因绝经引起的外阴和阴道内萎缩症状。2DOSAGEANDADMINISTRA