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Ovidrel Syringe injection 250μg(阿尔法绒毛膜促性腺激素预装注射器)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 250微克/支 
包装规格 250微克/支 
计价单位: 瓶 
生产厂家中文参考译名:
默克生物制药
生产厂家英文名:
Merck Bio Pharma Co.Ltd.
该药品相关信息网址1:
http://www.drugs.com/tecfidera.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Ovidrel(オビドレル皮下注シリンジ)250μg/Syringe
原产地英文药品名:
Choriogonadotropin Alfa(Genetical Recombination)
中文参考商品译名:
Ovidrel(オビドレル皮下注シリンジ)250微克/支
中文参考药品译名:
绒毛膜促性腺激素阿尔法
曾用名:
简介:

 

部份中文毛膜促性腺激素阿尔法重组处方资料(仅供参考)
商品名:Ovidrel Syringe
英文名:Choriogonadotropin Alfa
中文名:毛膜促性腺激素阿尔法重组注射器
生产商:默克生物制药
药品简介
近日,新药Ovidrel/Ovitrelle (Choriogonadotropin alfa,绒促性素α)治疗不孕症获日本批准。绒促性素α是一种重组的人绒毛膜促性腺激素,能促进卵泡成熟、恢复减数分裂,并启动排卵前卵泡破裂。该药用于治疗女性不排卵造成的不育症,但不适用于原发性卵巢功能衰竭。在日本绒促性素α是第一次获批。
オビドレル皮下注シリンジ250μg
药效分类名称
转基因人类促性腺激素制剂
批准日期:2017年3月
商標名
Ovidrel Syringe 250μg
一般名
コリオゴナドトロピン アルファ(遺伝子組換え)
Choriogonadotropin Alfa(Genetical Recombination)
本 質
Choriogonadotropin Alfa是一种转基因人类促性腺激素,由中国仓鼠卵巢细胞产生。Choriogonadotropin Alfa是一种糖蛋白,由由92个氨基酸残基和145个氨基酸残基组成的β亚单位组成(分子量:约70,000)。
批准条件
制定药品风险管理计划,并妥善实施。
药效药理
1. 受体结合亲和力
在MA-10莱迪希肿瘤细胞中,该剂与LH/hCG受体的结合亲和力与尿源hCG制剂相同。
2. 蛋成熟和黄体功能的影响
在由卵泡刺激激素刺激的成熟雌性蜥蜴中,该剂促进成熟卵子的形成,其受精程度与尿液衍生的hCG制剂相同,诱导黄体黄体黄体酮的产生。
适应症
下丘脑-与脑垂体功能障碍相关的无排卵或短排卵中的排卵诱导和黄体卵泡成熟和黄体在生殖辅助医学中的应用。
用法与用量
250μg作为Choriogonadotropin Alfa(基因重组)单皮下施用。
包装规格
1本/箱
存储方法、到期日期等
存储
2-8°C,遮光存储
到期日期
2 年(显示在外箱等上)
制造供应商
默克生物制药有限公司
供給元
Merck Serono S.A.(スイス)
注:以上中文资料不够完整,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/2413406G1020_1_04/
Ovidrel Syringe for Subcutaneous Injection 250mcg(Choriogonadotropin alfa[genetical recombination])
Brand name :Ovidrel Syringe for Subcutaneous Injection 250mcg
 Active ingredient:Choriogonadotropin alfa(genetical recombination)
 Dosage form:
injection
 Print on wrapping:
Effects of this medicine
This medicine induces ovulation by acting on ovary and promoting formation of mature eggs that can be fertilized.
It is usually used for ovulation induction and luteinization in anovulation or infrequent ovulation associated with hypothalamic-pituitary dysfunction. It is also used for follicular maturation and luteinization in assisted reproductive technology.
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 hypothalamic or pituitary tumor, unidentified ovarian enlargement or ovarian cyst, undiagnosed abnormal vaginal bleeding, or active thromboembolism.
If you have or are suspected of having ovarian cancer, uterine cancer or breast cancer.
If you are pregnant, possibly 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, inject this medicine subcutaneously, once.
Ask your doctor about the specified use of this medicine.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include ovarian hyperstimulation syndrome, erythema of injection site and ovarian cyst (abdominal bloating, lower abdominal pain, frequent urination). 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.
lower abdominal discomfort, nausea/vomiting, diarrhea [ovarian hyperstimulation syndrome]
breathing difficulty, chest distress, calf pain when pressed[thromboembolism]
respiratory distress, angioedema, hives[shock, anaphylaxis]
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.
Injection
Revised: 10/2019
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. 

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