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Volibris Tablets 2.5mg(Ambrisentan 安贝生坦片 ヴォリブリス錠)

2013-08-20 02:50:07  作者:新特药房  来源:互联网  浏览次数:370  文字大小:【】【】【
简介:商標名 Volibris Tablets2.5mg 一般名アンブリセンタン(Ambrisentan) 化学名(2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid 分子式C22H22N2O4 分子量378.42 構造式 性状白 ...

英文药名:Volibris Tablets(Ambrisentan)

中文药名:安贝生坦片

生产厂家:葛兰素史克公司

ヴォリブリス錠2.5mg

治疗类别名称
内皮素受体拮抗剂
上市批准日期:2010年9月
商標名
Volibris Tablets2.5mg
一般名
アンブリセンタン(Ambrisentan)
化学名
(2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid
分子式
C22H22N2O4
分子量
378.42
構造式

性状
白色の結晶性の粉末である。
分配係数(logP)
1.20(1-オクタノール/水
审批条件
通过实施各种情况下的使用,调查的结果,而从审判案件在全国已根据一定数量的,直到它被集成在案件极为有限,数据后市场,此药以及了解患者的使用的背景资料,收集关于此药的疗效和安全性的早期数据,采取必要的措施,正确使用此药。
药效与药理
(1)作用机理
ETA受体内皮素(ET)受体,这种药物选择性ETA受体拮抗剂指示(小于1/4000或ETA受体的亲和力)ETB受体的亲和力较低的高亲和力是一种药物。1被认为是血浆ET-1浓度高于PAH患者,主要是因为它的程度与病理及右心房压力,ET-1是重要的进步和发展PAH)。此代理将被认为通过肺血管ETA受体的抑制作用抑制ET-1的内源性肺血管平滑肌的生长和收缩,改善症状的PAH。
(2)肺动脉高压模型作用
在野百合碱诱导的肺动脉高压模型大鼠显着抑制(增加右心室收缩压,肺血管内侧肥厚和右心肥大)肺动脉高压的症状反复口服4周。
适应症:
用于治疗肺动脉高压
用法用量:
成人,每日口服一次,每次5mg。此外;适当的增量的范围内不超过根据症状每日10mg。
包装规格:
片剂
2.5毫克:60片 PTP(6片×10片)


生产销售:
日本葛兰素史克公司
完整资料阅读使用[附件]:http://www.info.pmda.go.jp/go/pack/2190031F1023_1_07/
GSK is a treatment for pulmonary arterial hypertension "Voribris tablet 2.5mg"
According to the press release of GlaxoSmithKline Inc., the company announced on September 17 that the company's pulmonary arterial pulmonary hypertension treatment "VOLIVIS tablet 2.5 mg" (generic name: ambrisentan.
"Voribris is an antagonist specific to propionate-based endothelin A receptor developed as a treatment for pulmonary arterial hypertension (PAH) Suppresses vasoconstriction and cell proliferation action by endothelin-1 It is thought that improving the clinical symptoms of PAH, "Voribris" is an oral medicine taken once a day, characterized by the risk of liver dysfunction and less drug interaction with concomitant medication is.
Since "Voribris" was approved in the United States in June 2007 and in Europe in April 2008, it has been approved in 40 countries around the world.
In Japan, as of May 16, 2007, we received designation of a drug for rare diseases, and on July 23, 2010 we got approval for adaptation of pulmonary arterial pulmonary hypertension.
In 1999, GSK launched the prostaglandin I 2 preparation "Intravenous Floran" (generic name: epoprostenol sodium) as the first therapeutic agent for PAH in Japan. The appearance of "Floran" greatly contributed to the improvement of the prognosis of patients with PAH, and the treatment environment surrounding this disease in Japan greatly changed. With the release of "Voribris" this time, GSK is now able to offer treatment medicine that matches the patient's severity from mild to severe.
GSK President Philip Foche describes the release of "Voribris" as follows. "GSK is actively working on the development of therapeutic drugs for rare diseases in which medical needs are present as well as therapeutic agents for patients with many diseases. With the release of" Voribris ", the cause of PAH is unknown I am very proud that we can offer new treatment options to patients who face conflict. GSK will continue to focus on R & D so as to give new hope to rare disease patients. "

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