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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->抗心率失常药物
处方药:处方药
包装规格: 400毫克/片 60片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
赛诺菲-安万特
生产厂家英文名:
sanofi-aventis
该药品相关信息网址1:
http://www.rxlist.com/multaq-drug.htm
该药品相关信息网址2:
https://www.multaq.com/cons/registration.aspx
原产地英文商品名:
MULTAQ 400mg/tablet 60tablets/bottle
原产地英文药品名:
DRONEDARONE HYDROCHLORIDE
原产地英文化合物名称:
N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-Methanesulfonamide hydrochloride
中文参考商品译名:
MULTAQ 400毫克/片 60片/瓶
中文参考药品译名:
盐酸决奈达隆
中文参考化合物名称:
N-[2-丁基-3-[4-[3-(二丁氨基)丙氧基]苯基]-5-苯并呋喃基]-甲烷磺酰胺盐酸盐
原产地国家批准上市年份:
2009/07/01
英文适应病症1:
atrial fibrillation
英文适应病症2:
atrial flutter
英文适应病症3:
heart disease
临床试验期:
完成
中文适应病症参考翻译1:
心房纤颤
中文适应病症参考翻译2:
心房扑动
中文适应病症参考翻译3:
心脏病
药品信息:

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 详细处方信息以本药内容附件PDF文件(20114800331512.pdf)的“原文Priscribing Information”为准
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     MULTAQ is a prescription medicine used to lower the chance that you would need to go into the hospital for heart problems. It is meant for people who have had an abnormal heart rhythm called atrial fibrillation or atrial flutter in the last six months but who do not have that abnormal rhythm now or are about to be converted to a normal rhythm. It may be safely used for people who have had atrial fibrillation and atrial flutter who also have medical problems such as high blood pressure, stroke, or diabetes.

Important Safety Information

What is the most important information I should know before taking MULTAQ?

MULTAQ is not for people with severe heart failure. People with severe heart failure who take MULTAQ have an increased chance of dying. Heart failure means your heart does not pump blood through your body as well as it should.

Do not take MULTAQ if you have severe heart failure:

where any physical activity causes shortness of breath or you have shortness of breath while at rest or after a small amount of exercise.

  • if you were hospitalized for heart failure within the last month even if you are better now.

Call your doctor right away if you have any signs and symptoms of worsening heart failure:

  • shortness of breath or wheezing at rest
  • wheezing, chest tightness or coughing up frothy sputum at rest, nighttime or after minor exercise
  • trouble sleeping or waking up at night because of breathing problems
  • using more pillows to prop yourself up at night so you can breathe more easily
  • gaining more than 5 pounds quickly
  • increasing swelling of feet or legs

It is not known if MULTAQ is safe and effective in children younger than age 18 years old.

Who should not take MULTAQ?

See "What is the most important information I should know about taking MULTAQ?"

Do not take MULTAQ if:

  • You have severe heart failure or have recently been in the hospital for heart failure, even if you are better now.
  • You have severe liver problems.
  • You take certain medicines that can change the amount of MULTAQ that gets into your body. Do not use these medicines with MULTAQ:
    • Nefazodone for depression
    • Norvir® (ritonavir) for HIV infection
    • Nizoral® (ketoconazole), and Sporanox® (itraconazole), and Vfend® (voriconazole) for fungal infections
    • Ketek® (telithromycin), Biaxin® (clarithromycin) for bacterial infections
    • Cyclosporine for organ transplant
  • You take certain medicines that can lead to a dangerous abnormal heart rhythm:
    • Some medicines for mental illness called phenothiazines
    • Some medicines for depression called tricyclic antidepressants
    • Some medicines for abnormal heart rhythm or fast heartbeat
    • Some medicines for bacterial infection

Ask your doctor if you are not sure if your medicine is one that is listed above.

  • You are pregnant or plan to become pregnant. It is not known if MULTAQ will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • You are breast-feeding or plan to breastfeed. It is not known if MULTAQ passes into your breast milk. You and your doctor should decide if you will take MULTAQ or breastfeed. You should not do both.

What should I tell my doctor before starting MULTAQ?

  • If you have any other heart problems
  • Tell your doctor about all the medicines you take, including any new medicines. Include all prescription and non-prescription medicines, vitamins and herbal remedies. MULTAQ and certain other medicines can react with each other, causing serious side effects. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Be sure to tell your doctor and pharmacist if you take:

  • medicine for high blood pressure, chest pain, or other heart conditions
  • statin medicine to lower blood cholesterol
  • medicine for TB (tuberculosis)
  • medicine for seizures
  • medicine for organ transplant
  • herbal supplement called St. John's wort

Some of these medicines could keep MULTAQ from working well or make it more likely for you to have side effects.

How should I take MULTAQ?

  • Take MULTAQ exactly as your doctor tells you.
  • Take MULTAQ two times a day with food, once with your morning meal and once with your evening meal.
  • Do not stop taking MULTAQ even if you are feeling well for a long time. The medicine may be working.
  • If you miss a dose, wait and take your next dose at your regular time. Do not take 2 doses at the same time. Do not try to make up for a missed dose.

What should I avoid while taking MULTAQ?

Do not drink grapefruit juice while you take MULTAQ. Grapefruit juice can increase the amount of MULTAQ in your blood and increase the likelihood that you will have a side effect of MULTAQ.

     Multaq(R)(决奈达隆)可降低心房颤动
 
    ATHENA 试验的进一步分析显示,ATHENA 试验的进一步分析显示,Multaq(R)(决奈达隆)可降低心房颤动患者的中风风险-- 这一分析表明,Multaq(R)(决奈达隆)使已充分接受抗血栓治疗的心房颤动或心房扑动患者的中风风险降低34%。
    巴黎2008年9月3日电 /新华美通/ -- ATHENA 试验的数据事后分析结果今天在德国慕尼黑举行的2008年欧洲心脏病学会 (European Society of Cardiology) 会议中的最新临床实验会议上公布。这一具有里程碑意义的 ATHENA 试验之前的统计结果表明,试验性药物 Multaq(R)(决奈达隆 (dronedarone))在进行标准治疗时,可使任何原因导致的心血管疾病住院或死亡风险的联合主要终点比安慰剂低24% (p=0.00000002) 之多。
    ATHENA 基于非预设的次要终点进行的中风事后分析显示,在充分接受包括抗血栓治疗在内的标准治疗的心房颤动或心房扑动患者中,Multaq(R) 与安慰剂相比可使中风(缺血性或出血性)风险降低34%(中风事件分别为46对70;p=0.027)。
    使用 Multaq(R) 中风风险的显著降低提高了诸如口服抗凝血剂和/或抗血小板制剂等抗血栓疗法的依据。与心血管病导致的住院或死亡的 ATHENA 主要终点类似,这一效果出现早,并在后续试验(12至30个月)中得以保持。
    加拿大汉密尔顿麦克马斯特大学 (Mc Master University) 心脏病学系教授、ATHENA 试验联合首席研究员 Stuart Connolly 表示:“ATHENA 是一次具有里程碑意义的试验,将引导心房颤动管理的重大转变,因为抗心律失常药物对心血管病结果产生重大影响这还是首次。由于中风是心房颤动的重要并发症之一,也是致死和长期残疾的主要原因,因此这些新结果体现了 Multaq(R) 除了单纯的心律和心率控制功效之外的独特功效。”

    在预设的安全分析中Multaq(R) 和安慰剂在 ATHENA 试验中最常出现的不良事件为胃肠道反应(26%对22%)、皮肤病(10%对8%,主要为皮疹)以及由于在肾脏中抑制肾小管肌酐分泌所致的血肌酐水平稍微升高(4.7%对1%)。在对健康志愿者进行的单独的研究中,血肌酐增高的机理得到了充分诠释。在 ATHENA 试验中,与安慰剂相比Multaq(R) 在抗心律失常方面则显示出更低的风险,并且因充血性心力衰竭造成的住院率更低。在这两个试验组中,试验药物的停药率基本相同。

                                                            心房颤动/扑动和中风简介
    心房颤动 (AF) 是临床实践中最常见的心律失常,并且是最重要的可引起中风的独立风险因素之一。中风是一个重大的公众健康问题,因为这种急性病常会造成永久性神经疾病和死亡。心房颤动可使中风的几率增长5倍。15%至20%的中风都与心房颤动有关,并且心房颤动造成的中风会使患者卧床不起的几率增长2.2倍。
    心房颤动是造成住院和死亡的一大因素,美国和欧盟分别有大约250万和450万人受到这种疾病的困扰。据 Atrial Fibrillation Foundation 估计,未来20年里心房颤动患者的人数将会翻倍。如果没有进行适当的治疗,心房颤动可引起中风和充血性心力衰竭等严重并发症。
                                                                ATHENA 研究简介
    具有里程碑意义的 ATHENA 试验是唯一一项在心房颤动患者身上对抗心律失常以及发病率和死亡率进行分析的双盲研究。该调查在37个国家的550多个地点展开,共招募了4628名患者。
    接受研究的患者的年龄要么在75岁或以上(有或没有心血管风险因素),要么在70岁以上且至少拥有另外一个心血管风险因素(高血压、糖尿病、脑血管相关病史、左室大于50mm 或左室射血分数低于40%)。患者随机接受400毫克 Multaq(R) BID 或安慰剂,最长持续30个月。
    这项 ATHENA 研究旨在表明,与安慰剂相比,Multaq(R) 在所有诱因死亡率的主要复合终点以及心血管疾病住院率方面拥有潜在优势。预设的二级终点是任何诱因导致的死亡、心血管疾病死亡和因患心血管疾病而住院。预设的安全终点是治疗紧急不良反应的发生率(在第一次服用研究药物和最后一次服用研究药物之后10天这一段时间内),这些紧急不良反应包括:所有不良反应、严重不良反应和导致研究药物中断的不良反应。
    ATHENA 还基于非预设二级终点进行了中风事后分析,这是为了检验 Multaq(R) 在减轻心房颤动或心房扑动患者患上中风等重大心脏血管并发症风险方面的持续效果。中风是造成这个患者群体因心脏血管疾病住院或死亡的领先因素。
                                                    Multaq(R) (dronedarone) 简介
    Multaq(R) 是一种尚处于调查研究阶段的疗法,也是唯一显示出能够显著降低心房颤动/心房扑动患者发病率和死亡率的安全的抗心律失常药物,其安全性已经通过较低的致心律失常(包括 torsades de pointes)以及心外器官毒性发病率而得到了证实。
    由赛诺菲-安万特 (Sanofi-aventis) 发现并开发的 Multaq(R) 是在一项包含7,000多名患者的临床开发计划框架内进行研究的。Multaq(R) 属于过去20年里心房颤动治疗领域的主要创新之一。
    美国食品和药物管理局 (FDA) 已经同意对 Multaq(R) 优先进行评审,欧洲药品管理局 (EMEA) 也开始就一份注册档案进行监管审核。   
 

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 详细处方信息以本药内容附件PDF文件(20114800331512.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-11-05
附件:








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