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英文药名：Wellnara Combination Tablets（Estradiol/Levonorgestrel）
中文药名：雌二醇/左炔诺孕酮配合錠
生产厂家：拜耳药品
ウェールナラ配合錠
治疗类别名称
口服雌激素-孕激素乐配方绝经后骨质疏松的治疗剂
商標名
Wellnara
雌二醇
構造式
一般名（JAN）
雌二醇
（Estradiol）
化学名
Estra-1,3,5（10）-triene-3,17β-diol
分子式
C18H24O2
分子量
272.38
融点
175～180℃
性状
本品是一种白色晶体或细小的黄色结晶粉末，没有异味。
此产品可自由可溶于1,4-二恶烷或N，所述N-甲基甲酰胺，容易微溶于丙酮，乙醇（95），以微溶，在乙醚中微溶，并且几乎不溶于水。
此产品可溶于硫酸。
本产品是吸湿。
左炔诺孕酮
構造式
一般名（JAN）
左炔诺孕酮
（Levonorgestrel）
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
本产品是一种白色结晶或结晶性粉末。
此产品是易于微溶于四氢呋喃或氯仿，乙腈，甲醇，乙醇（99.5），丙酮或乙醚微溶，并且几乎不溶于水。
药效药理
左炔诺孕酮为0.25mg/ kg的（SC）的结合物12个星期施用雌二醇在卵巢切除大鼠为2.5mg/kg /天（口服）或雌二醇为2.5mg/ kg的（口）癌，股骨和卵巢切除的第四抑制腰椎骨小梁密度的减小，观察到左炔诺孕酮组合的影响。此外，骨量，成形面19左炔诺孕酮组合的影响未在骨形成率观察到的）。
在N-甲基-N-亚硝基脲治疗的小鼠，以诱导子宫内膜增生和发生在雌二醇子宫内膜癌，左炔诺孕酮的联合给药以剂量依赖性方式20抑制发生这些频率）。21子宫重量的减少是由1/100-1/25的雌二醇剂量左炔诺孕酮的量）共同给予观察。
适应病症
绝经后骨质疏松
用法用量
片剂：成人每天口服给药一次1mg-0.04mg/片
包装规格
片剂
PTP包装 140片（28片×5），280片（28片×10）
制造商（进口）
拜耳药品社有限公司
Wellnara Combination Tablets（ウェールナラ配合錠）
Brand name : Wellnara Combination Tablets
Active ingredient: Estradiol
Levonorgestrel
Dosage form: pale red tablet, diameter: 6mm, thickness: 2.85mm
Print on wrapping: (face) ウェールナラ配合錠, SC
(back) ウェールナラ配合錠, Wellnara
Effects of this medicine
This medicine suppresses decreasing bone quantity by supplementing estradiol, a type of ovarian hormone. This medicine also contains levonorgestrel, a type of progestational hormone, to protect the endometrium from the actions of ovarian hormones.
It is usually used to treat postmenopausal osteoporosis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have or are suspected of having estrogen-dependent cancers (breast cancer, cancer of endometrium, etc.).
If you have a past medical history of breast cancer.
If you have or have a past medical history of thrombophlebitis, pulmonary embolism or arterial thromboembolic disease (coronary heart disease, stroke, etc.).
If you have liver disorder or undiagnosed abnormal genital bleeding.
If you have had a hysterectomy.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take one tablet at a time, once a day. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as you remember. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Avoid taking any food containing St. John's wort, since it may decrease the blood level of the medicine and diminish medicinal effects.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include breast discomfort, breast pain, genital discharge, genital bleeding, abdominal pain and nipple pain. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•leg pain/edema, chest pain, shortness of breath [venous thromboembolism, thrombophlebitis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
http://www.info.pmda.go.jp/go/pack/2482010F1026_1_10/
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