左炔诺孕酮释放子宫内系统（Mirena 52mg Intrauterine 1×1）说明书
[caption id="attachment_25747" align="alignleft" width="300"]
Mirena 52mg Intrauterine 1×1（左炔诺孕酮释放子宫内系统）[/caption]
药店国别：
产地国家：日本
处 方 药：是
所属类别：52毫克 1×1/盒
包装规格：52毫克 1×1/盒
计价单位：盒
生产厂家中文参考译名:拜耳药业
生产厂家英文名:Bayer Pharmaceutical Co.Ltd.
原产地英文商品名:Mirena(ミレーナ)52mg/Intrauterine System 1×1
原产地英文药品名:Levonorgestrel
中文参考商品译名:Mirena(ミレーナ)52毫克 1×1/盒
中文参考药品译名:左炔诺孕酮
简介：
部分中文左炔诺孕酮处方资料(仅供参考)
商品名称：Mirena
英文名称：Levonorgestrel
通用名称：左炔诺孕酮
剂 型：释放子宫内系统
生产厂家：拜耳药品
药效分类：子宫内黄体激素释放系统
批准日期：2007年4月
商标名：Mirena
一般名：レボノルゲストレル(Levonorgestrel)〔JAN〕
化学名：(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one
分子式：C21H28O2
分子量：312.45
融点：235～241℃
性状：本品为白色结晶或结晶性粉末。本品是四氢呋喃或略易溶于氯仿,乙腈、甲醇、乙醇(99.5),难溶于丙酮或乙醚,几乎不溶于水。
处理上的注意：
交换使用时间(时期)
安装后不超过5年中清除或交换
药效药理：
从本药剂中释放出的莱波诺格斯特蕾在子宫内起到局部的前列腺素作用，子宫内膜中的高浓度莱波诺格斯特蕾拉会导致子宫腺萎缩和间质脱落膜化等形态变化。本药剂的避孕效果主要取决于子宫内膜的局部作用，也有助于局部异物反应。同时，rebonorgel stral还提高宫颈管黏液的粘性，来阻止精子通过，部分女性会抑制排卵。通过对子宫内膜的形态学变化作用，可以减少月经血量。
适应症：避孕；月经过多
用法与用量：安装在子宫腔内。
临床成绩：
1.避孕
在国内临床试验中，第1年之前有482例中的2例2)，国外临床试验截止到第1年共报告了2848例中的4例怀孕情况。另外，通过第2245次海外临床试验获得的第5年累计怀孕率为0.71%。
2.月经过多
患有特发性月经过多※1患者为对象的海外随机化公开赛3)比较临床试验中,本药群※2及乙酸メドロキシプロゲステロン(mpa)群※3的基础线最终评价时的月经血的减少量(中央值),各-128.8 ml,-17.8 ml,两群之间有明显的差异。而且，治疗有效※为4的病例比例分别为84.8%(67/79例)及22.2%(18/81例)，两者之间有明显的差异。
月経血の減少量(mL) 月経血の減少量(mL)
本剤群(82例) -128.8 -393.6 ～ +1242.2
MPA群(83例) -17.8 -271.5 ～ +78.6
※1:用碱性海参测定的每一月经周期的月经血量在80ml以上
※2:从月经开始7天内安装子宫内，每隔30天使用6周期
※3:每一个月经周期的第16天开始10天内，1天10毫克每天服用6周期口服
4:月经血量不足80ml，且与基线相比月经血量减少50%以上
包装：1個×1，1個×3
制造商：拜耳药品公司
Levonoregstrell (52 mg)
On the insurance application to "dysmenorrhea"I would like to inform you about the history of the application and the insurance application of "the dysmenorrhea" of the reference of the effect and the effect of "dysmenorrhea" of the general name levonoregstrell (the name: Milena 552; this drug).
The efficacy and efficacy of the "dysmenorrhea" of this drug, which was held on April 22, 2014, was described as "the report on the relevance of the application to the known application," in the "unapproved medicine and the adaptive external medicine examination meeting with high medical necessity", and it is known that the effectiveness and safety are known in the Medical Pharmacy The validity of the petition Recognized.
After that, it was judged that it was possible not to be able to apply a known application in advance eva luation in the first eva luation in the first part of the pharmaceutical affairs and Food Hygiene Committee of the Ministry of health, labor and welfare held by the Ministry of health, labour and welfare held on May 30, and we made an application for the effect and effect addition on 27 June.
Regarding the drug listed in the standard of medical and pharmaceutical standards, the effect and effect of the prior eva luation of the application of the application in the pharmaceutical affairs and food sanitation Council is the subject of the insurance application even if it is outside the adaptation in the approval of the drug approval.According to the prescription of this drug to the standard of medical supply standard on September
Notification of the effect and effect on the subject of said system
0902 No.2, September 2, 2010 was issued, and it became an object of the insurance application.
The effect and effect of "dysmenorrhea" will be used outside the application until approved by the drug after the application. When using this drug for patients with "dysmenorrhea", we are open to the public for confirmation of the use of the "report on the applicability to the known application."
For patients or their families, please make an informed consent regarding the fact that the approval is not applicable to the approval of the medical treatment, the contents of the treatment and the possible side effects, etc.
Mirena 52mg Intrauterine 1×1（左炔诺孕酮释放子宫内系统）[/caption]
药店国别：
产地国家：日本
处 方 药：是
所属类别：52毫克 1×1/盒
包装规格：52毫克 1×1/盒
计价单位：盒
生产厂家中文参考译名:拜耳药业
生产厂家英文名:Bayer Pharmaceutical Co.Ltd.
原产地英文商品名:Mirena(ミレーナ)52mg/Intrauterine System 1×1
原产地英文药品名:Levonorgestrel
中文参考商品译名:Mirena(ミレーナ)52毫克 1×1/盒
中文参考药品译名:左炔诺孕酮
简介：
部分中文左炔诺孕酮处方资料(仅供参考)
商品名称：Mirena
英文名称：Levonorgestrel
通用名称：左炔诺孕酮
剂 型：释放子宫内系统
生产厂家：拜耳药品
药效分类：子宫内黄体激素释放系统
批准日期：2007年4月
商标名：Mirena
一般名：レボノルゲストレル(Levonorgestrel)〔JAN〕
化学名：(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one
分子式：C21H28O2
分子量：312.45
融点：235～241℃
性状：本品为白色结晶或结晶性粉末。本品是四氢呋喃或略易溶于氯仿,乙腈、甲醇、乙醇(99.5),难溶于丙酮或乙醚,几乎不溶于水。
处理上的注意：
交换使用时间(时期)
安装后不超过5年中清除或交换
药效药理：
从本药剂中释放出的莱波诺格斯特蕾在子宫内起到局部的前列腺素作用，子宫内膜中的高浓度莱波诺格斯特蕾拉会导致子宫腺萎缩和间质脱落膜化等形态变化。本药剂的避孕效果主要取决于子宫内膜的局部作用，也有助于局部异物反应。同时，rebonorgel stral还提高宫颈管黏液的粘性，来阻止精子通过，部分女性会抑制排卵。通过对子宫内膜的形态学变化作用，可以减少月经血量。
适应症：避孕；月经过多
用法与用量：安装在子宫腔内。
临床成绩：
1.避孕
在国内临床试验中，第1年之前有482例中的2例2)，国外临床试验截止到第1年共报告了2848例中的4例怀孕情况。另外，通过第2245次海外临床试验获得的第5年累计怀孕率为0.71%。
2.月经过多
患有特发性月经过多※1患者为对象的海外随机化公开赛3)比较临床试验中,本药群※2及乙酸メドロキシプロゲステロン(mpa)群※3的基础线最终评价时的月经血的减少量(中央值),各-128.8 ml,-17.8 ml,两群之间有明显的差异。而且，治疗有效※为4的病例比例分别为84.8%(67/79例)及22.2%(18/81例)，两者之间有明显的差异。
月経血の減少量(mL) 月経血の減少量(mL)
本剤群(82例) -128.8 -393.6 ～ +1242.2
MPA群(83例) -17.8 -271.5 ～ +78.6
※1:用碱性海参测定的每一月经周期的月经血量在80ml以上
※2:从月经开始7天内安装子宫内，每隔30天使用6周期
※3:每一个月经周期的第16天开始10天内，1天10毫克每天服用6周期口服
4:月经血量不足80ml，且与基线相比月经血量减少50%以上
包装：1個×1，1個×3
制造商：拜耳药品公司
Levonoregstrell (52 mg)
On the insurance application to "dysmenorrhea"I would like to inform you about the history of the application and the insurance application of "the dysmenorrhea" of the reference of the effect and the effect of "dysmenorrhea" of the general name levonoregstrell (the name: Milena 552; this drug).
The efficacy and efficacy of the "dysmenorrhea" of this drug, which was held on April 22, 2014, was described as "the report on the relevance of the application to the known application," in the "unapproved medicine and the adaptive external medicine examination meeting with high medical necessity", and it is known that the effectiveness and safety are known in the Medical Pharmacy The validity of the petition Recognized.
After that, it was judged that it was possible not to be able to apply a known application in advance eva luation in the first eva luation in the first part of the pharmaceutical affairs and Food Hygiene Committee of the Ministry of health, labor and welfare held by the Ministry of health, labour and welfare held on May 30, and we made an application for the effect and effect addition on 27 June.
Regarding the drug listed in the standard of medical and pharmaceutical standards, the effect and effect of the prior eva luation of the application of the application in the pharmaceutical affairs and food sanitation Council is the subject of the insurance application even if it is outside the adaptation in the approval of the drug approval.According to the prescription of this drug to the standard of medical supply standard on September
Notification of the effect and effect on the subject of said system
0902 No.2, September 2, 2010 was issued, and it became an object of the insurance application.
The effect and effect of "dysmenorrhea" will be used outside the application until approved by the drug after the application. When using this drug for patients with "dysmenorrhea", we are open to the public for confirmation of the use of the "report on the applicability to the known application."
For patients or their families, please make an informed consent regarding the fact that the approval is not applicable to the approval of the medical treatment, the contents of the treatment and the possible side effects, etc.
用药温馨提示：当您服用此药物时，需定期接受医疗专业人士的检查，以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助，不能代替医学建议和治疗。
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药品价格查询,专业药品查询网站,药品说明书查询,药品比价 » 左炔诺孕酮释放子宫内系统（Mirena 52mg Intrauterine 1×1）说明书
