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  药店国别: 美国药房
产地国家: 美国
所属类别: 泌尿生殖系统及泌乳药物->促排卵
处方药:处方药
包装规格: 450单位/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
默克雪兰诺
生产厂家英文名:
EMD SERONO
该药品相关信息网址1:
http://www.gonal-fcares.com/
该药品相关信息网址2:
http://www.rxlist.com/gonal-f-drug.htm
该药品相关信息网址3:
http://www.fertilitylifelines.com/resources/gonal-frffpen.jsp
原产地英文商品名:
GONAL-F 450IU/VIAL
原产地英文药品名:
FOLLITROPIN ALPHA,RECOMB
中文参考商品译名:
果纳芬 450单位/瓶
中文参考药品译名:
重组人促卵泡激素
原产地国家批准上市年份:
1997/09/29
英文适应病症1:
Failure to ovulate
英文适应病症2:
PCOD
英文适应病症3:
To stimulate multi-follicular development
英文适应病症4:
Stimulate sperm formation
临床试验期:
完成
中文适应病症参考翻译1:
不排卵
中文适应病症参考翻译2:
多囊卵巢综合症
中文适应病症参考翻译3:
刺激多卵泡发育
中文适应病症参考翻译4:
刺激精子形成
药品信息:

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 详细处方信息以本药内容附件PDF文件(201221919032038.pdf)的“原文Priscribing Information”为准
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部分中文果纳芬处方资料(仅供参考)

【商品名】果纳芬Gonal-F

【通用名】注射用重组人促卵泡激素(rFSH)

【规格】75IU

【适应症】主要用于无排卵患者:包括对克罗米酚无反应的多囊卵巢综合征患者。在辅助生殖技术中,如体外受精(IVF)、配子输卵管内移植(GIFT)及合子输卵管内移植(ZIFT)患者的超排卵。
  具体适应症:
  (1)不排卵(包括多囊卵巢综合症[PCOD]),而且对枸椽酸克罗米酚无反应的妇女。
  (2)对于超排卵或辅助生育技术,如体外受精-胚胎移植(IVF)、配予输卵管内转移(GIFT)和合子输卵管内移植(ZIFT)的患者,用果纳芬可刺激多卵泡发育。
  (3)先天或后天性男性性腺功能不良的促性腺激素水平低下,以刺激精子形成。

【性状】外观为白色冷冻干燥,无菌,无热原的粉末

【用药方案】
1.以刺激单个卵泡发育为目的的诱发排卵。在月经周期的第7日内开始治疗,每日75IU-150IU促卵泡激素开始。通过监测卵泡的大水和/或雌激素水平来评价病人的反应。如有必要每7或14天增加37.5IU或75IU(直至225IU)以达到充分而非过度的反应。当达到满意的反应时,应在末次注射果纳芬24-48小时后一次性注射绒促性腺激素(hCG)10,000IU并在当日或次日同房。如果患者在治疗5周后反应不充分,应放弃此周期,并且在下一次治疗时使用比上周期更高的启动剂量;如果反应过度,应停止治疗,同时停止使用人绒促性腺激素(hCG),并在下一个周期以较低剂量重新开始治疗。
2.以刺激多个卵泡发育为目的的超排卵方案:从周期第2或3天开始,每日注射果纳芬150-225IU,以血清雌激素浓度和/或超声波监测,直到卵泡发育充分为止。根据病人反应调整剂量,通常不高于每日450IU。在果纳芬末次注射24-48小时后,一次性注射剂量为10,000IU的人绒毛膜促性腺激素(hCG),以诱导卵泡的最终成熟。

【用法用量】患者常在促性腺激素释放激素激动剂使用2周之后给予本药,常用方案为月经周期2-3天开始使用150-225iu,根据患者的反应调节剂量。

【不良反应/副作用】腹痛,可能伴有恶心、呕吐及体重增加。偶见腹水、胸水和严重的血栓并发症。

【注意事项】有卵巢过度刺激征发生的可能,但通过仔细监测和不用hCG可减少其发生。对超排卵患者,穿刺抽吸所有卵泡。有卵巢病史者可能发生宫外孕。

【禁忌】妊娠,非多囊卵巢综合征的卵巢增大或囊肿,月经紊乱,卵巢、子宫或乳腺癌,下丘脑或垂体肿瘤,对本品过敏或无反应者。

【孕妇及哺乳期妇女用药】尚不明确

【药物相互作用】尚不明确

【贮藏】密封。

Gonal Product Contains
Follitropin alfa, r-FSH

Product Indications
Gonal-f (Follitropin alfa, r-FSH) is another recombinant (synthetic) version of human follicle stimulating hormone, almost identical to that contained in Follistim. Available data tell us the differences between the two versions of the hormone are indistinguishable. It is indicated for women undergoing Ovulation Induction Treatment and also for women participating in an Assisted Reproductive Technology (ART) program, such as in vitro fertilization.

Gonal Dosage and Administration
NOTE: During FSH treatment and for 2 weeks after treatment, patients need to be checked every day (or every other day) for signs of too much ovarian stimulation.

Induction of ovulation and pregnancy in patients who do not ovulate when infertility is not due to ovarian failure

Initial dose 75 IU subcutaneously once daily. Dose may be increased by 37.5 IU/day. Maximum dose 300 IU/day. Response is evident within 5-7 days. Duration of treatment should not exceed 35 days. hCG should be given 1 day after the last dose unless the serum estradiol is greater than 2000 pg/mL.

For the development for multiple follicles in patient¿s participating in assisted reproductive programs

Initial dose 150 IU subcutaneously in the early follicular phase (days 2 or 3) and continue 150 IU once daily until follicle development is adequate Administer hCG should be administered to retrieve oocyte. Retrieval should occur 34-36 hours later Do not exceed 10 days of therapy If needed initial dose can be 225 IU/day and may be increased by 75-150 IU/day (every 3-5 days). Maximum dose 450 IU/day.

Gonal Warnings, Side Effects and Potential Drug Interactions
•Discontinue treatment if the ovaries become abnormally enlarged or if abdominal pain occurs and contact your physician
•Do not use if pregnant or breastfeeding
•Sexual intercourse is prohibited if ovaries are enlarged
•Product can exacerbate asthma and other pulmonary conditions
•May enhance some cancers such as ovarian or breast cancer

Gonal Storage
•Store in refrigerator or at room temperature, between 36°-77° F (2°-25° C).
•Once reconstituted, discard after 28 days.
•Avoid excessive heat, humidity, and light.
•Do not shake.

Gonal Manufacturer
Emd Serono, Inc

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 详细处方信息以本药内容附件PDF文件(201221919032038.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-2-20
附件:


201221919032038.PDF    

 
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