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PROCHIEVE(孕酮阴道凝胶)-不孕症新药

2011-02-16 11:37:11  作者:新特药房  来源:中国新特药网天津分站  浏览次数:243  文字大小:【】【】【
简介: Important Safety InformationProchieve 4% is indicated for the treatment of secondary amenorrhea. In clinical studies, the most commonly reported adverse events for Prochieve 4% when used ...

Important Safety Information
Prochieve 4% is indicated for the treatment of secondary amenorrhea. In clinical studies, the most commonly reported adverse events for Prochieve 4% when used with estrogen therapy were cramps, bloating, fatigue, headache, depression, emotional lability, and sleep disorder.

Prochieve 4% is contraindicated for use in individuals with known sensitivity to Prochieve 4% (progesterone or any of the other ingredients); undiagnosed vaginal bleeding; liver dysfunction or disease; known or suspected malignancy of the breast or genital organs; missed abortion; active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders. If thrombotic disorders occur or are suspected, Prochieve 4% should be discontinued immediately.


PROCHIEVE 8%凝胶(90毫克孕酮)/18根/盒

Generic Name for PROCHIEVE
Progesterone (micronized) 4% (45mg/applicatorful), 8%
(90mg/applicatorful); vaginal gel; contains mineral oil.
Legal Classification:
Rx

Manufacturer of PROCHIEVE
Columbia Laboratories
      
Indications for PROCHIEVE
Secondary amenorrhea.
      
Adult dose for PROCHIEVE
Initially one applicatorful of 4% (45mg) intravaginally every other day up to a total of 6 doses. If inadequate response may give 1 applicatorful of 8% (90mg)intravaginally every other day for a total of 6 doses.
Children's dosing for PROCHIEVE
Not applicable.
      
Contraindications for PROCHIEVE
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Warnings/Precautions for PROCHIEVE
Conditions aggravated by fluid retention. Depression. Include Pap smear with pretreatment exam. Discontinue if signs of thrombotic disorders (eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinal
thrombosis) occur. Pregnancy: see literature. Nursing mothers.
Interactions for PROCHIEVE
Allow at least 6 hours between administration of this and other vaginally-administered products.
Adverse Reactions for PROCHIEVE
Cramps, emotional lability, fatigue, sleep disorders, depression, headache, bloating, vaginal discharge, nausea, changes in appetite, back or abdominal pain, myalgia, pruritus genital, others.
      
How is PROCHIEVE supplied?
Prefilled applicators 4%—6
Prefilled applicators 8%—6, 18
Related Disease:
Amenorrhea~menopausal disorders
Menopausal disorders

通用名称PROCHIEVE
孕酮(微粉)4%(45mg/applicatorful),8%(90mg/applicatorful);阴道凝胶,含有矿物油。

法律分类:
接收

制造商PROCHIEVE
哥伦比亚实验室
       
适应症PROCHIEVE
继发性闭经。

成人剂量PROCHIEVE
最初一4%(45mg)intravaginally每隔一天applicatorful最多为6次总计。如果不充分的反应可能会剂量为6共计1 8%(90毫克)intravaginally每隔一天applicatorful。

儿童剂量为PROCHIEVE
不适用。

禁忌的PROCHIEVE
未经诊断的阴道出血。乳房或生殖器癌。肝功能障碍或疾病。过期流产。血栓性静脉炎或血栓栓塞性疾病。

警告/注意事项的PROCHIEVE
由水肿加重条件。抑郁症。包括子宫颈抹片检查与治疗前考试。停止的迹象,如果血栓性疾病(如血栓性静脉炎,脑血管疾病,肺栓塞,视网膜血栓形成)发生。妊娠:见文献。哺乳的母亲。

互作PROCHIEVE
允许至少6间这个问题和其他阴道管理的产品管理小时。

不良反应为PROCHIEVE
痉挛,情绪不稳,疲劳,睡眠障碍,抑郁,头痛,腹胀,阴道分泌物,恶心,食欲改变,背部或腹部疼痛,肌肉痛,皮肤瘙痒外阴,等等。

Generic Name for PROCHIEVE
Progesterone (micronized) 4% (45mg/applicatorful), 8%
(90mg/applicatorful); vaginal gel; contains mineral oil.
Legal Classification:
Rx

Manufacturer of PROCHIEVE
Columbia Laboratories
      
Indications for PROCHIEVE
8% strength: Progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
      
Adult dose for PROCHIEVE
Supplementation: 1 applicatorful of 8% (90mg) intravaginally once daily.
Replacement: 1 applicatorful of 8% (90mg) intravaginally twice daily. If pregnancy occurs, may continue treatment until placental autonomy is achieved (10–12 weeks).
Children's dosing for PROCHIEVE
Not applicable.
      
Contraindications for PROCHIEVE
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Warnings/Precautions for PROCHIEVE
Conditions aggravated by fluid retention. Depression. Include Pap smear with pretreatment exam. Discontinue if signs of thrombotic disorders (eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinal
thrombosis) occur. Pregnancy: see literature. Nursing mothers.
Interactions for PROCHIEVE
Allow at least 6 hours between administration of this and other vaginally-administered products.
Adverse Reactions for PROCHIEVE
Mastodynia, constipation, somnolence, GI upset, headache,
abdominal/perineal pain, nervousness, cramps, nocturia, depression, decreased libido, arthralgia, bloating, pain, vaginal candidiasis/discharge, dizziness, dyspareunia, pruritus genital, allergy, fatigue, urinary tract infection, others.
      
How is PROCHIEVE supplied?
Prefilled applicators 4%—6
Prefilled applicators 8%—6, 18
      
Related Disease:

通用名称PROCHIEVE
孕酮(微粉)4%(45mg/applicatorful),8%(90mg/applicatorful);阴道凝胶,含有矿物油。
法律分类:
接收

制造商PROCHIEVE
哥伦比亚实验室
       
适应症PROCHIEVE
8%的力量:孕激素补充或替代,作为一种辅助生殖技术(ART)的不孕妇女与孕激素缺乏症治疗的一部分。
      
成人剂量PROCHIEVE
补充:1 8%(90毫克),每日一次applicatorfulintravaginally。更换:1 8%(90毫克),每日两次applicatorful intravaginally。如果怀孕时,胎盘可继续治疗,直到实现自治(10-12周)。
儿童剂量为PROCHIEVE
不适用。
      
禁忌的PROCHIEVE
未经诊断的阴道出血。乳房或生殖器癌。肝功能障碍或疾病。过期流产。血栓性静脉炎或血栓栓塞性疾病。
警告/注意事项的PROCHIEVE
由水肿加重条件。抑郁症。包括子宫颈抹片检查与治疗前考试。停止的迹象,如果血栓性疾病(如血栓性静脉炎,脑血管疾病,肺栓塞,视网膜血栓形成)发生。妊娠:见文献。哺乳的母亲。

互作PROCHIEVE
允许至少6间这个问题和其他阴道管理的产品管理小时。
不良反应为PROCHIEVE
Mastodynia,便秘,嗜睡,胃肠不适,头痛,腹痛/会阴疼痛,紧张,痉挛,夜尿,抑郁,性欲减退,关节痛,腹胀,疼痛,阴道念珠菌/放电,头晕,性交疼痛,外阴瘙痒,过敏,疲劳,泌尿呼吸道感染,等等。
 
如何PROCHIEVE提供?
4%-6预灌封喷头
8%-6,18预灌封喷头

孕酮(微粉)4%(45mg/applicatorful),8%(90mg/applicatorful);阴道凝胶
产地英文商品名:
PROCHIEVE 4% GEL WITH APPLICATOR 1 X 6'S 45GM /BOX
原产地英文药品名:PROGESTERONE,MICRONIZED
中文参考商品译名:PROCHIEVE 4%凝胶(45毫克孕酮)6跟/盒
中文参考药品译名:PROGESTERONE,MICRONIZED
生产厂家中文参考译名:Columbia Laboratories Inc
生产厂家英文名:Columbia Laboratories Inc

责任编辑:admin


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