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  药店国别: 美国药房
产地国家: 美国
所属类别: 糖尿病->2型糖尿病
处方药:处方药
包装规格: (15毫克/1000毫克)/片 30片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
武田美国公司
生产厂家英文名:
Takeda Pharmaceuticals America.Inc.
该药品相关信息网址1:
http://www.actos.com/actospro/home.aspx
该药品相关信息网址2:
http://www.actos.com/actospro/prescribinginfo.aspx
原产地英文商品名:
ACTOPLUS MET XR TB 24HOURS (15mg/1000mg)tablet 30tablets/box
原产地英文药品名:
PIOGLITAZONE HCL/METFORMIN HCL
中文参考商品译名:
ACTOPLUS MET XR 24小时缓释片(15毫克/1000毫克)/片 30片/盒
中文参考药品译名:
盐酸吡格列酮/盐酸二甲双胍
原产地国家批准上市年份:
2009/05/12
英文适应病症1:
Type 2 Diabetes Mellitus
英文适应病症2:
Diabetes Mellitus
临床试验期:
完成
中文适应病症参考翻译1:
2型糖尿病
中文适应病症参考翻译2:
糖尿病
药品信息:

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 详细处方信息以本药内容附件PDF文件(201071422464316.pdf)的“原文Priscribing Information”为准
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部分中文ACTOPLUS MET XR处方资料(仅供参考)

FDA 批准 ACTOplus met(R) XR 片剂用于治疗2型糖尿病

    美通社-PR Newswire5月13日伊利诺伊州迪尔菲尔德和日本大阪电 Takeda Pharmaceutical Company Limited 及其全资子公司 Takeda Pharmaceuticals North America, Inc. 今天宣布,美国食品和药物管理局 (U.S. Food and Drug Administration, FDA) 已批准将缓释型组合药物 ACTOplus met(R)(盐酸匹格列酮 (pioglitazone HCl) 和盐酸二甲双胍 (metformin HCl))作为治疗2型糖尿病的一种饮食和锻炼辅助剂。ACTOplus met(R) XR 是首款也是唯一一款带有二甲双胍缓释剂的抗糖尿病固定剂量口服组合药物,旨在通过每天一次的方便的剂量选择帮助改善血糖控制。ACTOplus met XR 用于对已经采用 ACTOS(R)(盐酸匹格列酮)和二甲双胍治疗的进行治疗,或者单独采用 ACTOS 或二甲双胍治疗而不足以控制血糖的2型糖尿病成年患者。
    ACTOplus met XR 将两种广泛使用的药物 ACTOS 和二甲双胍结合到一个药片上。ACTOS 直接针对胰岛素抵抗。胰岛素抵抗是一种身体不能有效使用身体产生的胰岛素的疾病。二甲双胍通过减少肝脏产生的葡萄糖的数量起作用。这些药物联合发挥作用,帮助2型糖尿病患者管理他们的血糖水平。
ACTOplus met XR 的主要活性成分之一二甲双胍缓释剂由 Watson Pharmaceuticals, Inc. 子公司 Watson Laboratories 开发而成,并授权给 Takeda Pharmaceutical Company Limited。

     Actoplus Met为胶囊剂,该药含有武田公司已有的另一种糖尿病药Actos(罗格列酮)和二甲双胍两种成分。
    武田制药美国分公司将在十月份推出Actoplus Met。它将与葛兰素史克公司的Avandamet进行竞争,Avandamet含有罗格列酮和二甲双胍。
    Actos直接作用于胰岛素阻抗性----即人体无法有效利用自身产生的胰岛素,而二甲双胍主要用于减少人体肝脏产生的葡萄糖数量。
    武田公司称,这种复方制剂可以减少II型糖尿病患者的血糖浓度。

LINCOLNSHIRE, Ill., August 29, 2005 ?Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ACTOplus metTM for the treatment of type 2 diabetes. This is the second Takeda product approved in the U.S. this summer, following the approval of ROZEREMTM (ramelteon) on July 22, 2005.
ACTOplus met combines ACTOS (pioglitazone HCl) and metformin, two widely used diabetes medications, in a single tablet. ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.

To offer physicians greater flexibility in treating their patient's needs, ACTOplus met will be available in two dosages of pioglitazone/metformin ?15 mg/500 mg and 15 mg/850 mg ?both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling.

"To reach target blood glucose levels, many people with type 2 diabetes will have to take a combination of therapies. In fact, within three years of being prescribed their first medication, approximately 50 percent of patients will need to add additional therapies to manage their condition," said Ralph DeFronzo, M.D., professor of Medicine and chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio. "ACTOplus met may help patients reduce the number of pills they take each day, and offers a new and convenient treatment option."

According to the American Diabetes Association, diabetes affects more than 18 million people, and type 2 diabetes is the most common form of the disease. Both ACTOS and metformin are widely used medications in the treatment of type 2 diabetes and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease.

Takeda Global Research & Development Center, Inc. submitted the ACTOplus met NDA in October 2004. Takeda expects the medication to be available to patients by October 2005.

"Takeda is committed to developing appropriate treatment options for healthcare providers and their patients," said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. "ACTOplus met reflects that commitment by offering a convenient option for people with type 2 diabetes and an important new addition to the ACTOS portfolio."


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 详细处方信息以本药内容附件PDF文件(201071422464316.pdf)的“原文Priscribing Information”为准
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