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  药店国别: 欧洲共同体药房
产地国家: 瑞士
所属类别: 影响血液及造血系统药物->溶栓抗凝药物
处方药:处方药
包装规格: 60毫克/片 168片/盒
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.astrazeneca.com/
该药品相关信息网址2:
http://www.medicines.org.uk/EMC/medicine/23935/SPC/Brilique+90+mg+film+coated+tablets/
原产地英文商品名:
BRILIQUE 60mg/tab 168tabs/box
原产地英文药品名:
TICAGRELOR
中文参考商品译名:
BRILIQUE 60毫克/片 168片/盒
中文参考药品译名:
替卡格雷
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Acute coronary syndrome
英文适应病症2:
Anti-platelet aggregation
英文适应病症3:
Antithrombotic
临床试验期:
完成
中文适应病症参考翻译1:
急性冠脉综合症
中文适应病症参考翻译2:
抗血小板聚集
中文适应病症参考翻译3:
抗血栓
药品信息:

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 详细处方信息以本药内容附件PDF文件(20114621590117.pdf)的“原文Priscribing Information”为准
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部分中文替卡格雷处方资料(仅供参考)

欧洲批准抗凝血药Ticagrelor(Brilique)
    AstraZeneca公司表示欧洲药品管理局推荐批准抗凝血药Ticagrelor上市,在欧洲将于商品名Brilique销售,用于急性冠脉综合症患者形成危险的血栓。
    12月,公司获准在欧盟地区销售它最重要的实验性产品Brilinta(也称为Brilique)。在研究中,这只预防血栓的药物证明要比赛诺菲-安万特和百时美施贵宝公司联合销售的Plavix更加有效,去年Plavix实现了98亿美元的销售额。
  尽管如此,12月17日,FDA并没有批准Brilinta,并表示,它希望获得更多的比较Brilinta和Plavix的研究分析数据。分析家表示,此举有可能使FDA的审批决定推迟到2011年下半年。如果获得批准,那么该药将是Plavix的唯一竞争对手。

替卡格雷片剂(Ticagrelor,Brilint)
    目前越来越多的抗血小板聚集药物进入临床。由阿斯利康研发的新型抗凝药——替卡格雷更是有望成为格雷类口服抗血小板聚集和抗血栓类鼎足药物。
    替卡格雷是一种新型的、具有选择性的小分子抗凝血药,也是第一个可逆的结合型口服P2Y12腺苷二磷酸受体拮抗剂,能可逆性地作用于血管平滑肌细胞(VSMC)上的嘌呤2受体亚型P2Y12,对ADP引起的血小板聚集有明显的抑制作用,能有效改善急性冠心病患者的症状。因为替卡格雷的可逆性抗血小板作用,尤为适用于那些需在先期进行抗凝治疗后再行手术的病人。
    用小鼠的主动脉环进行的研究发现,氯吡格雷不能阻断血管平滑肌细胞收缩,可能是因为其活性代谢物在循环系统中极不稳定而不能起效;而替卡格雷可以阻断由P2Y12受体介导的ADP引起的血管平滑肌细胞收缩,即使是先使用氯吡格雷后发生收缩的血管平滑肌在加用替卡格雷后,收缩也会受到进一步抑制。空白对照组和氯吡格雷组的最大收缩率分别为59%和64%;当给予替卡格雷后,两组的收缩率分别达到33%和32%。
    一项名为DISPERSE的多中心的Ⅱa期试验中,200名患有稳定型动脉粥样硬化的病人被随机给予替卡格雷(50,100或200mg,hid,或400mg,qd)或氯吡格雷(75mg,qd)加阿司匹林(75—100mg,qd),用药时间为28天。结果表明,与氯吡格雷相比,替卡格雷(100mg或以上,bid)的起效更快、更持久、对血小板凝集的抑制作用更强(90%vs60%)。
    所有使用替卡格雷患者对该药都能很好地耐受;使用替卡格雷药造成的所有出血事件大多不甚严重,只有在最大用药量(400mg,qd)时,出现1例比较大的出血事件;替卡格雷组有呼吸困难的情况出现,且发生率呈剂量依赖性:5O和100mg(bid)组的发生率为10%、200mg(bid)组为16%.400mg(qd)组则为20%,但情况并不严重,亦未发生与心力衰竭、支气管痉挛等相关的症状。由不良事件而导致的停药呈剂量相关,随着替卡格雷的剂量从5Omg,bid上升到400mg,qd,停药率从2.5%增加到8.6%,而氯吡格雷的停药率为2.7%。

What is Brilique?
Brilique is a medicine that contains the active substance ticagrelor. It is available as round, yellow tablets (90 mg).

What is Brilique used for?
Brilique is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes. It is used in adults who have had a heart attack or have unstable angina (a type of chest pain caused by problems with the blood flow to the heart).

The medicine can only be obtained with a prescription.

How is Brilique used?
The starting dose of Brilique is two tablets taken at once, followed by a regular dose of one tablet taken twice a day. Patients should also be taking aspirin as directed by their doctor. The doctor may, for health reasons, tell them not to take aspirin. They should continue treatment for up to a year unless, the doctor asks them to stop taking the medicine.

How does Brilique work?
The active substance in Brilique, ticagrelor, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.

How has Brilique been studied?
The effects of Brilique were first tested in experimental models before being studied in humans.

Brilique was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina. The patients also took aspirin and were treated for up to a year. The main measure of effectiveness was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.

What benefit has Brilique shown during the studies?
Brilique was shown to be beneficial to patients who have had a heart attack or unstable angina. In the main study, 9.3% of the patients taking Brilique had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.

What is the risk associated with Brilique?
The most common side effects with Brilique (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured). For the full list of all side effects reported with Brilique, see the package leaflet.

Brilique should not be used in people who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients. It must not be used in patients who have moderate to severe liver disease or are currently bleeding, or in patients who have had a stroke caused by bleeding within the brain. It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4). These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).

Why has Brilique been approved?
The CHMP noted that the main study showed that, compared with clopidogrel, Brilique reduces the risk of heart attacks and cardiovascular deaths. However Brilique was not more effective than clopidogrel in reducing the risk of stroke.

The CHMP decided that Brilique’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Brilique
The European Commission granted a marketing authorisation valid throughout the European Union for Brilique to AstraZeneca on 03 December 2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Brilique, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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 详细处方信息以本药内容附件PDF文件(20114621590117.pdf)的“原文Priscribing Information”为准
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2011-4-7更新

更新日期: 2018-08-01
附件:




20114621590117.pdf    

 
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