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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->尿失禁、尿急和尿频
处方药:处方药
包装规格: 25毫克/片 100片/盒
计价单位:
   
生产厂家中文参考译名:
安斯泰来
生产厂家英文名:
Astellas
该药品相关信息网址1:
http://www.rxlist.com/myrbetriq-drug/indications-dosage.htm
该药品相关信息网址2:
http://www.myrbetriq.com/what-is-myrbetriq-oab-medication?WT.mc_id=70097&WT.srch=1&MTD=2&ENG=1&CMP=3&gclid=CLDL4or_-bsCFQecKgodugoAAA&gclsrc=ds
该药品相关信息网址3:
http://www.bio360.net/news/show/1311.html
原产地英文商品名:
MYRBETRIQ ER 25MG 100Tablets
原产地英文药品名:
MIRABEGRON
中文参考商品译名:
MYRBETRIQ缓释片 25毫克/片 100片/盒
中文参考药品译名:
米拉贝隆
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Overactive bladder (OAB)
英文适应病症2:
Urgency
英文适应病症3:
Symptoms of frequency
英文适应病症4:
Symptoms of leakage
临床试验期:
完成
中文适应病症参考翻译1:
膀胱过度活动症
中文适应病症参考翻译2:
尿急
中文适应病症参考翻译3:
尿频
中文适应病症参考翻译4:
尿泄漏
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201411217494611.pdf)的“原文Prescribing Information”为准
---------------------------------------------------------------
部分中文米拉贝隆处方资料(仅供参考)

6月28日,安斯泰来制药(Astellas)旗下Astellas美国分公司宣布

Myrbetriq(mirabegron缓释片)获FDA批准用于膀胱过动症(OAB)。

公司指出,Myrbetriq的建议起始剂量为每次25mg,每日一次,空腹或随食物同服。25 mg剂量Myrbetriq在8周内有效;基于个人的疗效和耐受性,其药物剂量可增至50mg/天。 Myrbetriq(mirabegron)是种β-3肾上腺素受体激动剂,可用于缓解OAB引起的急迫性尿失禁、尿急及尿频等症状。

公司推出Myrbetriq的包装规格为25 mg及50 mg,预计于今年第4季度上市。

Mirabegron曾于2011年7月获批在日本上市,现正接受其他国家监管部门的审批。

Myrbetriq® (mirabegron) was approved by the FDA to treat overactive bladder with symptoms of urgency, frequency, and leakage. Myrbetriq is the first and only drug in its class for treating OAB. It was studied in three 12-week clinical trials involving 3500 patients and was shown to be effective in treating symptoms of OAB including urgency, frequency, and leakage within the first several weeks. Those taking Myrbetriq made fewer trips to the bathroom and had fewer leaks than those not taking Myrbetriq. It may take several weeks to see results, so stick with it.

Myrbetriq™ is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Dosing Information

The recommended starting dose of Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily [see Clinical Studies.

Myrbetriq should be taken with water, swallowed whole and should not be chewed, divided, or crushed

Myrbetriq may cause serious side effects including:

Increased Blood Pressure: Myrbetriq may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking Myrbetriq.

Inability to Empty Your Bladder (Urinary Retention): Myrbetriq may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of Myrbetriq include

increased blood pressure

common cold symptoms (nasopharyngitis)

urinary tract infection

headache

Tell your doctor if you have any side effect that bothers you or that does not go away or if you have hives, skin rash, or itching while taking Myrbetriq. These are not all the possible side effects of Myrbetriq. For more information, ask your doctor or pharmacist.

更新日期: 2014-1-15
附件:


201411217494611.pdf    

 
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