DuoPlavin被欧盟重点推荐应用
2009年12月17日，EMEA的CHMP通过了一项积极的意见，建议批准DuoPlavin（一种新的硫酸氯吡格雷和阿司匹林固定的组合物）的上市许可。这种药物被批准用于动脉粥样硬化已经在使用氯吡格雷和阿司匹林的成人患者急性冠状动脉综合征的预防。
欧洲委员会已批准Sanofi-Aventis公司具有双重抗血小板作用的复方片剂DuoPlavin/Du oCo ver(clopidogrel 75mg + acetylsalicylic acid 100mg 或75 mg，氯吡格雷+阿司匹林)用于预防已在服用氯吡格雷和阿司匹林两种药物的成人患者发生动脉粥样化血栓形成事件。这 种固定剂量的复方片剂用于非-ST段抬高的急性冠脉综合征（不稳定性心绞痛或非-Q波心肌梗死，包括进行经皮冠脉介入治疗后植入支架的患者）患者，及已在接受治疗并适于溶栓疗法的ST段抬高的急性心肌梗死患者。
DuoPlavin 75 mg/100 mg film-coated tablets
Active substance: Clopidogrel, Voriconazole
Producers: Sanofi Pharma Bristol-Myers Squibb SNC
ATC-Code: B01AC30
Date of authorization: 15/03/2010
Therapeutic area: Acute Coronary SyndromeMyocardial Infarction
What is it?
DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin). It is available as oval tablets containing 75 mg clopidogrel, either with 75 mg (yellow) or 100 mg acetylsalicylic acid (pink).
What is it used for?
DuoPlavin is used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries), such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid. It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome’.
patients who are having ‘unstable angina’ (a severe type of chest pain) or a myocardial infarction (heart attack) with no ‘ST-segment elevation’ (an abnormal reading on the ECG or electrocardiogram), including in patients having a stent (a short tube) inserted into an artery to prevent it from closing up;patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).
The medicine can only be obtained with a prescription.
How is it used?
DuoPlavin is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
How does it work?
Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are ‘inhibitors of platelet aggregation’. This means that they help to prevent cells in the blood called platelets from aggregating (sticking together) and forming clots. Clopidogrel stops the platelets aggregating by blocking a substance called ADP from
attaching to a special receptor on their surface.
This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming.
Acetylsalicylic acid stops the platelets aggregating by blocking an enzyme called prostaglandin cyclo oxygenase.
This reduces the production of a substance called thromboxane, which normally helps clots to form by binding platelets together. When taken together, the two active substances can reduce the risk of problems due to blood clots forming, helping to prevent another heart attack.
Both active substances have been available in the European Union(EU) for a number of years. Clopidogrel has been authorised as Plavix and Iscover since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.
How has it been studied?
Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed in the body in the same way as the two medicines taken separately.
It also presented the results of previous studies involving over 60,000 patients with acute coronary syndrome, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was effective at preventing atherothrombotic events such as heart attacks.
What benefits has it shown during the studies?
DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
What is the risk associated?
The most common side effects with DuoPlavin (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage(bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin
is punctured. For the full list of all side effects reported with DuoPlavin, see the Package Leaflet.
DuoPlavin should not be used in people who may be hypersensitive(allergic) to clopidogrel, non steroidal anti-inflammatory drugs(such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin. It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain.
It must not be used in patients who have severe liver or kidney problems, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
DuoPlavin must not be used during the last three months of pregnancy.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets. The Committee therefore decided that DuoPlavin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
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注：以下产品规格和价格均不同，购买以咨询为准！
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产地国家: 西班牙
原产地英文商品名:
Duocover (75/100)mg/tab 28tabs/box
原产地英文药品名:
CLOPIDOGREL/ACETYLSALICYLIC ACID
中文参考商品译名:
Duocover (75/100)毫克/片 28片/盒
中文参考药品译名:
氯吡格雷/阿司匹林
生产厂家中文参考译名:
Bristol-Myers Squibb GmbH
生产厂家英文名:
Bristol-Myers Squibb GmbH
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产地国家: 德国
原产地英文商品名:
Duocover (75/100)mg/tab 100tabs/box
原产地英文药品名:
CLOPIDOGREL/ACETYLSALICYLIC ACID
中文参考商品译名:
Duocover (75/100)毫克/片 100片/盒
中文参考药品译名:
氯吡格雷/阿司匹林
生产厂家中文参考译名:
Bristol-Myers Squibb GmbH
生产厂家英文名:
Bristol-Myers Squibb GmbH
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产地国家: 德国
原产地英文商品名:
Duocover (75/100)mg/tab 28tabs/box
原产地英文药品名:
CLOPIDOGREL/ACETYLSALICYLIC ACID
中文参考商品译名:
Duocover (75/100)毫克/片 28片/盒
中文参考药品译名:
氯吡格雷/阿司匹林
生产厂家中文参考译名:
Bristol-Myers Squibb GmbH
生产厂家英文名:
Bristol-Myers Squibb GmbH