您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8420 处方药 8047 非处方药 267 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国内客服电话:
国际免费电话:


QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 德国药房
产地国家: 德国
所属类别: 作用于呼吸系统药物->慢性阻塞性肺病
处方药:处方药
包装规格: 500微克 30 FTA
计价单位:
  点击放大  
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca
该药品相关信息网址1:
http://www.msd-ireland.com/
该药品相关信息网址2:
http://www.meerburgpharmacy.com/daxas.htm
原产地英文商品名:
DAXAS 500μg 30 FTA (Min. order 20)
原产地英文药品名:
ROFLUMILAST
原产地英文化合物名称:
3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
中文参考商品译名:
DAXAS 500微克 30 FTA (最低购买量:20)
中文参考药品译名:
罗氟司特
中文参考化合物名称:
3-(环丙基甲氧基)-N-(3,5-二氯吡啶-4-基)-4-(二氟甲氧基)苯甲酰胺
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
COPD
临床试验期:
完成
中文适应病症参考翻译1:
慢性阻塞性肺病
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201122819000622.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文罗氟司特处方资料(仅供参考)

英文名:Roflumilast 

别名:3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

产品名称:罗氟司特; 3-(环丙基甲氧基)-N-(3,5-二氯吡啶-4-基)-4-(二氟甲氧基)苯甲酰胺

    Daxas(R)(罗氟司特)是一种口服的选择性磷酸二酯酶4 (PDE4) 抑制剂,该药品已经证明能够以一种崭新的作用方式抑制与慢性阻塞性肺病 (COPD) 有关的炎症[5]。作为一天口服一次的药片,Daxas(R)(罗氟司特)不仅是严重 COPD 新疗法中的第一种药品,而且是第一种面向 COPD 患者的口服抗炎药。

    四项大型随机安慰剂对照试验已经证明,在和第一线维持性疗法共同使用时,罗氟司特能够极大地抑制病情的恶化,而且可以改进肺功能。

    Daxas(R)(罗氟司特)的药物耐受性普遍良好。在涉及12,000名患者的临床 COPD 试验中,最常见的副作用是腹泻(5.9%)、体重下降(3.4%)、呕吐(2.9%)、腹痛(1.9%)和头痛(1.7%)。大部分副作用都很温和或适中。这些反应主要发生在治疗开始后的第一周,且大部分随着持续治疗而消失。

About Daxas
Nycomed's Daxas is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor targeting cells and mediators in the body believed to be important in the COPD disease process. Daxas is expected to act on the underlying mechanism of COPD and related inflammatory diseases. It could significantly improve the way these conditions are managed, reducing exacerbations requiring medical intervention, including hospitalisation. If approved, Daxas, a once-a-day tablet, will be the first drug in its class. It will also be the first new approach to the management of COPD in a generation. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

Nycomed's Daxas® (roflumilast) receives marketing authorisation in the European Union 
Nycomed
Nycomed announced that the European Commission has granted marketing authorisation for Daxas® (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD, a progressive, life-threatening lung disease. Daxas® is indicated for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. Daxas, an oral tablet taken once a day, is the first drug in a new class and is expected to be launched soon in the first European countries, starting with Germany and the UK.
Commenting on today's announcement, Guido Oelkers, Executive Vice President Commercial Operations at Nycomed, said: "Nycomed is very excited about the marketing authorisation for Daxas in the European Union. It is an important milestone for the company and very good news for people suffering from this life-threatening disease. The approval of Daxas offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies."

"There is a real need for new COPD treatment options," added Professor Klaus F. Rabe, University Medical Centre Leiden, Netherlands. "Daxas is a novel therapy which improves lung function and most importantly reduces exacerbations. It has a unique mode of action which targets the underlying inflammation in COPD and is an important addition to the current options available to doctors and patients."

Neil Barnes, Professor of Respiratory Medicine at Barts and the London Hospital, London, UK, said: "We have a large number of patients who remain symptomatic and have frequent exacerbations despite existing treatments, and for that more severe end of the spectrum we need new therapeutic options. The main additional benefit of Daxas on top of what is already achieved with bronchodilators is to reduce the number of exacerbations, or flare ups, which are the events that really concern the patients who experience them. For patients with COPD associated with chronic bronchitis and a history of flare ups, Daxas can make a real contribution."

The application to the EMA was based on encouraging results from four Phase III trials of roflumilast in the treatment of symptomatic COPD. In two pivotal placebo controlled, 12-month studies involving a total of over 3,000 patients with COPD, roflumilast demonstrated statistically significant improvements on both co-primary endpoints; moderate to severe exacerbations and pre-bronchodilator FEV1(1). The effect of Daxas was independent of concomitant use of long-acting beta2-agonist (LABA)(1). Roflumilast also demonstrated a statistically significant improvement compared to placebo on lung function, in two supportive studies over a six month period when added to the commonly used long-acting bronchodilators tiotropium or salmeterol(2).

Full data from all four studies were published in The Lancet in August 2009 and were presented at the annual European Respiratory Society (ERS) Congress in Vienna, Austria, in September 2009.

On April 26, 2010, Nycomed and Merck & Co., Inc. (based in Whitehouse Station, New Jersey and known as MSD outside the USA and Canada) announced that they had entered into an agreement to co-promote Daxas in France, Germany, Italy, Spain, Portugal and Canada. Nycomed will manufacture and distribute the finished product in all countries covered by the co-promotion agreement. In addition, the two companies have signed an exclusive distribution agreement for the commercialization of Daxas in the United Kingdom. Nycomed will supply finished product and has retained a co-promotion option.

Nycomed submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) in July 2009 and has signed a collaboration and distribution agreement for Daxas in the US with Forest Laboratories, Inc. (NYSE: FRX) in August 2009.
 
---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201122819000622.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-3-24
附件:
201122819000622.pdf    

201122817375810.JPG    





 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国内客服电话:     国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com