※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 注：以上中文处方资料不够完整，使用者以原处方资料为准。 完整说明书附件： https://www.info.pmda.go.jp/go/pack/2529710X1027_1_07/
------------------------------------------------------------------- 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.
其他说明（处理配套设备等）
请参阅“安装和拆卸说明”具体的安装和拆卸方法。 http://www.info.pmda.go.jp/go/pack/2482011F1020_1_10/ http://gynecology.bayer.jp/ja/home/product/mirena/index.php
