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  药店国别: 美国药房
产地国家: 德国
所属类别: 妇科药物->更年期综合症
处方药:处方药
包装规格: 0.05毫克/日 8片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
拜耳医疗
生产厂家英文名:
BAYER HEALTHCARE
该药品相关信息网址1:
http://www.climara.com/
该药品相关信息网址2:
http://www.medicinenet.com/estradiol/article.htm
该药品相关信息网址3:
http://www.yuanchengtech.com/Ch/ProductView.asp?ID=32180
原产地英文商品名:
CLIMARA TDS 0.05MG/DAY 8PATCHES/BOX
原产地英文药品名:
ESTRADIOL
中文参考商品译名:
康美华TDS 0.05毫克/日 8片/盒
中文参考药品译名:
雌二醇
原产地国家批准上市年份:
1994/12/22
英文适应病症1:
Reduce moderate to severe hot flashes after menopause
英文适应病症2:
Treat moderate to severe dryness, itching, and burning in or around the vagina after menopause
英文适应病症3:
Treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturally
英文适应病症4:
Help reduce your chances of getting osteoporosis (thin weak bones) after menopause
临床试验期:
完成
中文适应病症参考翻译1:
治疗绝经后中至重度潮热
中文适应病症参考翻译2:
治疗绝经后中至重度阴道干燥,瘙痒
中文适应病症参考翻译3:
治疗某些情况下年轻女性内源性雌激素分泌不足
中文适应病症参考翻译4:
预防绝经后骨质疏松症
药品信息:

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详细处方信息以本药内容附件PDF文件(20101903574039.pdf)的“原文Priscribing Information”为准
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部分中文 CLIMARA 处方信息(仅供参考)

CLIMARA is the once-a-week estrogen therapy (ET) patch that provides relief from symptoms of menopause such as hot flashes and night sweats triggered by the surgical removal of the uterus and ovaries.Types of surgery that trigger menopause:the surgical removal of the uterus (a hysterectomy), with or without the removal of the ovaries, may trigger surgical menopause.

What is CLIMARA used for?
CLIMARA is used after menopause to:
Reduce moderate to severe hot flashes
Treat moderate to severe dryness, itching, and burning in or around the vagina
Treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturally
Help reduce your chances of getting osteoporosis (thin weak bones)
When prescribing solely for vaginal dryness or osteoporosis, other treatments should be considered.

What is the most important information I should know about CLIMARA (an estrogen hormone)?
Estrogens increase the chances of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause
may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast
cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia.
You and your healthcare provider should talk regularly about whether you still need treatment with CLIMARA.

Who should not use CLIMARA?
Do not start using CLIMARA if you have unusual vaginal bleeding, currently have or have had certain cancers, had
a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to CLIMARA or any of its ingredients, or think you may be pregnant.

What are the warnings of less common but serious side effects of CLIMARA?
Warnings of less common but serious side effects of CLIMARA include breast lumps, unusual vaginal bleeding,
dizziness and faintness, changes in speech, severe headaches, chest pain, shortness of breath, pains in your legs, changes in vision, and vomiting. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

What are common side effects of CLIMARA?
Common side effects of CLIMARA include headache, breast pain, irregular vaginal bleeding or spotting,
stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss.

名称: 康美华  
药物成分:雌二醇
药理作用: 补充和替代雌激素的分泌不足。本贴片可持续释放雌二醇,通过皮肤(透皮)达到血液循环,并产生一个恒定的血清激
素水平。 康美华为12.5 Cm2贴片,含有存在于丙烯酸盐粘着基质中的3.9 mg雌二醇。康美华加强型为25 Cm2贴片,含有存在于丙烯酸盐粘着基质中的7.8 mg雌二醇。
适应症: 雌激素替代疗法用于因自然绝经或手术后闭经(仅因非恶性肿瘤疾病)引起的紊乱,如血管舒缩症状(潮红,出汗),睡眠
障碍。因内源性雌激素产生不足引起的萎缩。

用法用量: 每周使用1个贴片,如果贴片脱掉,在7天剂量剩下的日子内使用一个新贴片。通常用康美华开始治疗,如有必要,可使用康美华加强型。除非已行子宫切除术,否则应使用对抗性雌激素治疗,有子宫的妇女,应每月常规用10-12天的适量孕激素。如选择连续治疗方案,可以在任意选择的日子开始使用孕激素(如月初或月末),并且约每隔4周再重复使用。如选择周期性(用药3周,停药1周)治疗方案,孕激素应在周期的最后10-12天使用。在正常情况下,孕激素使用期结束后2-3天会发生月经样出血。
不良反应 用药部位的皮肤刺激症状。突破性出血和点滴出血,子宫肌瘤体积增大,宫颈分泌物量改变。乳房胀痛、增大。恶心、
腹痛、腹胀,胆汁淤积性黄疸。黄褐斑或黑斑病可能持续存在。个别病例发生过敏性接触性皮炎、瘙痒和扩散性皮疹。头痛、偏头痛、眩晕。体重改变,卟啉症加重,浮肿,性欲改变。

禁忌: 妊娠及哺乳期。疑有或现有子宫、乳腺或卵巢肿瘤 ;子宫内膜异位症 ;严重的肝功能损害 ;既往有或现有肝脏肿瘤、血栓栓塞(血栓性静脉炎,血栓形成) ;严重糖尿病伴有血管病变 ;镰状细胞性贫血 ;脂代谢紊乱 ;妊娠疱疹史 ;妊娠期耳硬化症恶化 ;既往妊娠期有黄疸或持久性瘙痒。

注意事项:1. 取掉保护衬后,粘着面应贴在清洁、干燥的躯干皮肤上,不应贴在乳房部位。用药部位应轮换,在某一特定部位的用药应至少间隔1周。不应选择多油、损伤或发炎的部位。应避免贴在腰线上,因为紧贴的衣服容易将贴片擦掉,在打开包装和取掉保护衬后应立即使用贴片。
2.贴片放置后用手掌紧压约10秒钟,以确保接触良好,尤其是边缘部位。如贴片使用正确,患者能象平常一样洗澡和淋浴,然而
,在洗热水澡或桑拿浴时贴片可能从皮肤上脱掉。
3. 开始用药前,应作彻底的全身检查和妇科检查(包括乳房和阴道细胞涂片),并除外妊娠。治疗期间应每隔约6个月作对照检查
。 如第一次发作偏头痛或异常严重的头痛发作频率增加 ;突发的感觉障碍(如视力或听力异常) ;血栓性静脉炎或血栓栓塞性疾病的最初征兆(如下肢异常疼痛或肿胀,无明显原因的呼吸或咳嗽时刺痛) ;胸痛或胸闷感 ;择期手术(前6周) ;固定术(如意外事故后) ;发生黄疸、肝炎、全身瘙痒、癫痫发作增多、血压明显升高、妊娠者应立即停药。如适用,应采用非激素方法避孕(安全期和测体温方法除外)。
4. 如在使用期间反复发生不规则出血,或者在非治疗周内出血量过多,应注意查找病因。
5.如有反复发作的、持久的皮肤刺激现象(如用药部位持久性红斑或瘙痒),即使在变换用药部位后仍存在,则应考虑停止透皮治
疗。
6.更年期长期单独使用雌激素能引起子宫内膜增生,因而增加子宫内膜癌的危险性。加用孕激素(正常每月10-12天),能极大地降
低这种危险性。
7.患有糖尿病、高血压、静脉曲张、耳硬化症、多发性硬化症、癫痫、卟啉症、手足搐搦症、小舞蹈病、心力衰竭、肾或肝功能
损害、偏头痛患者慎用。
8.患有乳腺纤维囊腺病或患者的近亲中有乳腺癌者应密切监护。
8.子宫平滑肌良性肿瘤的患者因雌激素治疗能使肿瘤增大。
9.罕见个别良性或极少数恶性肝脏肿瘤患者服用激素药物后,可能发生威胁生命的腹腔出血。

相互作用: 与巴比妥类、保泰松、乙内酰脲、利福平合用,可能影响本药的药效,同时口服的降糖药或胰岛素的剂量可能需要调整。

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详细处方信息以本药内容附件PDF文件(20101903574039.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-6-27
附件:






20101903574039.pdf    

 
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