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FDA批准阿哌沙班使用说明书的更新

2014-02-25 王菲 中国科学报

美国食品药品监督管理局(FDA)宣布,批准百时美施贵宝公司修改旗下口服抗凝剂阿哌沙班(Eliquis)的使用说明书。该说明书对血液透析的终末期肾病患者用量进行了更新。 该药物的原使用说明书显示,阿哌沙班适用于非瓣膜性心房颤动病人的中风和全身性栓塞的风险。修改后的说明书显示,对于使用血液透析的终末期肾病患者,用量为一日两次,每次5毫克,而对于年龄超过80岁以上或体重在60公斤以下的病人,剂

美国食品药品监督管理局(FDA)宣布,批准百时美施贵宝公司修改旗下口服抗凝剂阿哌沙班(Eliquis)的使用说明书。该说明书对血液透析的终末期肾病患者用量进行了更新。


该药物的原使用说明书显示,阿哌沙班适用于非瓣膜性心房颤动病人的中风和全身性栓塞的风险。修改后的说明书显示,对于使用血液透析的终末期肾病患者,用量为一日两次,每次5毫克,而对于年龄超过80岁以上或体重在60公斤以下的病人,剂量则减半至2.5毫克,一日两次。

这款由百时美施贵宝和辉瑞联合开发的药物在2013年4月正式在中国上市。该药物在国内仅适用于髋关节或膝关节择期置换术的成年患者,用于预防静脉血栓栓塞症。由于国外同药物的适应症范围要比国内上市的品种更加广泛,不排除百时美施贵宝和辉瑞会申请扩大适应症的可能。据公开资料显示,在国内,南京润诺生物科技有限公司已经申报了该药物,目前正在处于审评阶段


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    2014-07-18 bugit
  2. [GetPortalCommentsPageByObjectIdResponse(id=1839278, encodeId=c74218392e828, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Jul 18 04:36:00 CST 2014, time=2014-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=8067, encodeId=c7b7806e45, content=和想象相似。, beContent=null, objectType=article, channel=null, level=null, likeNumber=143, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f1286833, createdName=sence, createdTime=Tue Mar 04 22:40:00 CST 2014, time=2014-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507115, encodeId=e336150e115b0, content=<a href='/topic/show?id=18849189139' target=_blank style='color:#2F92EE;'>#说明书#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91891, encryptionId=18849189139, topicName=说明书)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3da79876963, createdName=yangpeizhi, createdTime=Thu Feb 27 02:36:00 CST 2014, time=2014-02-27, status=1, ipAttribution=)]
    2014-03-04 sence

    和想象相似。

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1839278, encodeId=c74218392e828, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Jul 18 04:36:00 CST 2014, time=2014-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=8067, encodeId=c7b7806e45, content=和想象相似。, beContent=null, objectType=article, channel=null, level=null, likeNumber=143, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f1286833, createdName=sence, createdTime=Tue Mar 04 22:40:00 CST 2014, time=2014-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507115, encodeId=e336150e115b0, content=<a href='/topic/show?id=18849189139' target=_blank style='color:#2F92EE;'>#说明书#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91891, encryptionId=18849189139, topicName=说明书)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3da79876963, createdName=yangpeizhi, createdTime=Thu Feb 27 02:36:00 CST 2014, time=2014-02-27, status=1, ipAttribution=)]
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