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  药店国别: 日本药房
产地国家: 日本
所属类别: 心血管系统药物->抗血栓药物
处方药:处方药
包装规格: 30毫克/片 100片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
第一三共
生产厂家英文名:
Daiichi Sankyo
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/3339002F1020_1_01/
该药品相关信息网址2:
http://www.daiichisankyo.com/rd/project/du176b/index.html
该药品相关信息网址3:
http://www.rxlist.cn/index.php?m=content&c=index&a=show&catid=273&id=40379
原产地英文商品名:
LIXIANA(リクシアナ) 30mg/tab 100tabs/box
原产地英文药品名:
EDOXABAN TOSILATE HYDRATE
原产地英文化合物名称:
N -(5-Chloropyridin-2-yl)-N '-[(1S ,2R ,4S )-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c ]pyridine-2-carboxamido)cyclohexyl]oxamide mono(4-
中文参考商品译名:
LIXIANA(リクシアナ) 30毫克/片 100片/盒
中文参考药品译名:
甲苯磺酸依度沙班水合物
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Venous thromboembolism
英文适应病症2:
Anticoagulant
临床试验期:
完成
中文适应病症参考翻译1:
静脉血栓栓塞症
中文适应病症参考翻译2:
抗凝血
药品信息:

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 详细处方信息以本药内容附件PDF文件(20125920460336.pdf)的“原文Priscribing Information”为准
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部分中文LIXIANA处方资料(仅供参考)

第一三共在日本推出在大型骨科手术後预防静脉血栓栓塞症的口服直接 Xa 因数抑制剂 LIXIANA (edoxaban)
    第一三共株式会社 (Daiichi Sankyo Company, Limited)(以下简称「第一三共」)欣然宣布在日本推出 LIXIANA (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban),这进一步扩大了公司的心血管产品组合。在这则消息公布之前日本厚生省 (Japanese Ministry of Health, Labor and Welfare) 于2011年4月对 edoxaban 的15毫克和30毫克片剂给予了首个销售许可。此次公布这一消息表明全球各个市场内的病人第一次能够购买到 edoxaban。
    Edoxaban 是一种每日口服一次的抗凝血剂,它可以直接专门对特定的酶——Xa 因数(血液里的一种凝血因数)进行可逆的抑制。Edoxaban 获准用来为进行全膝关节置换术、全髋关节置换术、髋部骨折手术的病人预防静脉血栓栓塞症 (VTE),临床研究结果对此表示支持。
    第一三共总裁兼首席执行官 Joli Nakayama 说:「今天推出 edoxaban 是该药物在全球首次亮相。这对于在大型骨科手术後需要预防 VTE 的病人来说是一项激动人心的突破。Edoxaban 在此类病人的临床试验中疗效显着。它的药代动力学和药效学特点都可以预见,这让病人每天方便地口服一次。」

口服抗凝血药Lixiana®在日本上市
    4月22日,日本厚生省批准了第一三共的Lixiana®(甲苯磺酸依度沙班水合物) 15 mg和30 mg用于预防骨科大手术后静脉血栓栓塞,这是Lixiana®获得的首个上市许可。
  Lixiana®系每日1次的口服抗凝血药,其活性成分依度沙班(Edoxaban)能直接抑制凝血因子Xa,临床结果显示,Lixiana®对全膝关节置换术、全髋关节置换术和髋骨折手术患者有良好的治疗益处。
  2010年3月,第一三共递交了Lixiana®用于静脉血栓栓塞适应症的上市申请,12月,公司公开了最新III期临床试验(Stars J-V)的正面结果,发现依度沙班能预防全髋关节置换术后静脉血栓栓塞事件,且有效性优于依诺肝素。
  依度沙班还在进行多个全球临床试验,适应症有预防房颤患者中风,以及预防和治疗静脉血栓栓塞复发。正在进行的III期AF-TMI试验,共入组21,000例患者,评估依度沙班对房颤患者预防中风和全身性栓塞事件的作用。正在进行的VTE试验,共入组7,500例患者,评估依度沙班对复方静脉血栓栓塞的预防和治疗作用。

Edoxaban
Factor Xa Inhibitor Offering Effective Therapy for Venous Thrombosis
Edoxaban (DU-176b) inhibits the activities of Factor Xa, and plays an important role in inhibiting blood coagulation and preventing thrombosis.

Like the antiplatelet agent Prasugrel, it is designed for the treatment of thromboembolic diseases. While antiplatelet agents work on diseases associated with arterial thrombosis, in particular on cerebral and myocardial infarctions, the Factor Xa inhibitor Edoxaban is expected to offer an effective therapy for venous thrombosis.
A venous thrombosis is a blood clot resulting from the slowing down of the blood flow, e.g. the so-called Economy Class Syndrome, a thrombosis caused by poor blood circulation in the veins of the legs when the legs are kept angled in a seating position for a long duration. Clots may travel through the bloodstream to the lungs and block the pulmonary vessels, resulting in the severe impairment of pulmonary functions (pulmonary thromboembolism triggered by deep vein thrombosis).
Blood clots formed through stagnation of the blood flow due to cardiac arrhythmias may travel by way of the blood circulation to the brain and block the cerebral vessels, resulting in cerebral embolism (thromboembolism triggered by atrial fibrillation). 

Arterial ThrombosisVenous Thrombosis
Myocardial infarction
Cerebral infarction
Economy Class Syndrome
(Pulmonary embolism)
Cerebral embolism
Antiplatelet agent
suppresses platelet coagulation
Anticoagulant (Factor Xa Inhibitor)
inhibits the formation of fibrin responsible for blood coagulation
Prasugrel (CS-747) Edoxaban (DU-176b)

Promising New Drug Developed Inhouse
In past clinical studies up to Phase II, Edoxaban was proven to have high oral absorption and to provide a significant improvement in side effects (bleeding risk) as well as faster onset of pharmacological action (antithrombotic action) in comparison with existing anticoagulants (warfarin and heparin). Furthermore, high utility is expected from its relative ease of dosage control.
In view of the mounting competition between pharmaceutical manufacturers over the development of Factor Xa Inhibitors, we are pressing ahead with large-scale Phase III trials around the world in pursuit of a best-in-class product. Our hopes are pinned on Edoxaban, a new drug with great market potential, to follow the success of Prasugrel.

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 详细处方信息以本药内容附件PDF文件(20125920460336.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2012-5-10
附件:


20125920460336.pdf    

 
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