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又一药物说明书修订 仅用于幽门螺旋杆菌感染

2018-08-02 佚名 药事网

呋喃唑酮片
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国家药品监督管理局关于修订呋喃唑酮片说明书的公告（2018年第43号）根据药品不良反应评估结果，为进一步保障公众用药安全，国家药品监督管理局决定对呋喃唑酮片说明书【适应症】、【禁忌】、【儿童用药】、【注意事项】等项进行修订，并增加【警示语】。现将有关事项公告如下：一、所有呋喃唑酮片生产企业均应依据《药品注册管理办法》等有关规定，按照呋喃唑酮片说明书修订要求（见附件），提出修订说明书的补充申请，于2

国家药品监督管理局关于修订呋喃唑酮片说明书的公告

（2018年第43号）

根据药品不良反应评估结果，为进一步保障公众用药安全，国家药品监督管理局决定对呋喃唑酮片说明书【适应症】、【禁忌】、【儿童用药】、【注意事项】等项进行修订，并增加【警示语】。现将有关事项公告如下：

一、所有呋喃唑酮片生产企业均应依据《药品注册管理办法》等有关规定，按照呋喃唑酮片说明书修订要求（见附件），提出修订说明书的补充申请，于2018年9月15日前报省级食品药品监管部门备案。

修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在补充申请备案后6个月内对所有已出厂的药品说明书及标签予以更换。

各呋喃唑酮片生产企业应当对新增不良反应发生机制开展深入研究，采取有效措施做好使用和安全性问题的宣传培训，指导医师合理用药。

二、临床医师应当仔细阅读呋喃唑酮片说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的效益／风险分析。

三、患者应严格遵医嘱用药，用药前应当仔细阅读说明书。

特此公告。

附件

呋喃唑酮片说明书修订要求

一、增加【警示语】

葡萄糖-6-磷酸脱氢酶缺乏性患者使用本品容易发生溶血性贫血，禁用于该人群。随着用药时间延长和用药剂量的增加，容易发生不可逆的神经炎；呋喃唑酮可发生严重的皮肤反应，如血清病样荨麻疹等。

二、【适应症】项修改为

本品仅用于难以根除的幽门螺旋杆菌感染。

三、在【禁忌】项下增加以下内容

葡萄糖-6-磷酸脱氢酶（G-6PD）缺乏者禁用。

四、在【儿童用药】项下增加以下内容

14岁以下儿童禁用。

五、在【注意事项】项下增加以下内容

动物实验显示呋喃唑酮对动物有致癌风险，但临床至今未有对人类致癌的病例报道，建议使用时权衡利弊。

（注：说明书其他内容如与上述修订要求不一致的，应当一并进行修订。）

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1811614, encodeId=970518116145c, content=<a href='/topic/show?id=88e78889092' target=_blank style='color:#2F92EE;'>#螺旋杆菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88890, encryptionId=88e78889092, topicName=螺旋杆菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Fri Aug 03 22:18:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343369, encodeId=defb34336924, content=谢谢提醒。学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:45:31 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343368, encodeId=c348343368ed, content=谢谢提醒, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:44:58 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507185, encodeId=bc7f150e1853c, 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=35, 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=Sat Aug 04 08:18:00 CST 2018, time=2018-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335905, encodeId=73443359055d, content=与时俱进啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Aug 03 05:58:31 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335816, encodeId=6839335816ed, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Thu Aug 02 18:42:33 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-03 hxj0117

    #螺旋杆菌#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1811614, encodeId=970518116145c, content=<a href='/topic/show?id=88e78889092' target=_blank style='color:#2F92EE;'>#螺旋杆菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88890, encryptionId=88e78889092, topicName=螺旋杆菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Fri Aug 03 22:18:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343369, encodeId=defb34336924, content=谢谢提醒。学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:45:31 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343368, encodeId=c348343368ed, content=谢谢提醒, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:44:58 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507185, encodeId=bc7f150e1853c, 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=35, 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=Sat Aug 04 08:18:00 CST 2018, time=2018-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335905, encodeId=73443359055d, content=与时俱进啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Aug 03 05:58:31 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335816, encodeId=6839335816ed, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Thu Aug 02 18:42:33 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-09-07 chinadoctorliu_19344479

    谢谢提醒。学习了。

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1811614, encodeId=970518116145c, content=<a href='/topic/show?id=88e78889092' target=_blank style='color:#2F92EE;'>#螺旋杆菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88890, encryptionId=88e78889092, topicName=螺旋杆菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Fri Aug 03 22:18:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343369, encodeId=defb34336924, content=谢谢提醒。学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:45:31 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343368, encodeId=c348343368ed, content=谢谢提醒, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:44:58 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507185, encodeId=bc7f150e1853c, 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=35, 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=Sat Aug 04 08:18:00 CST 2018, time=2018-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335905, encodeId=73443359055d, content=与时俱进啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Aug 03 05:58:31 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335816, encodeId=6839335816ed, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Thu Aug 02 18:42:33 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-09-07 chinadoctorliu_19344479

    谢谢提醒

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1811614, encodeId=970518116145c, content=<a href='/topic/show?id=88e78889092' target=_blank style='color:#2F92EE;'>#螺旋杆菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88890, encryptionId=88e78889092, topicName=螺旋杆菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Fri Aug 03 22:18:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343369, encodeId=defb34336924, content=谢谢提醒。学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:45:31 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=343368, encodeId=c348343368ed, content=谢谢提醒, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/08/06/a313b29462d38919a70f6ff00472d6b4.jpg, createdBy=86572414239, createdName=chinadoctorliu_19344479, createdTime=Fri Sep 07 07:44:58 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507185, encodeId=bc7f150e1853c, 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=35, 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=Sat Aug 04 08:18:00 CST 2018, time=2018-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335905, encodeId=73443359055d, content=与时俱进啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Aug 03 05:58:31 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335816, encodeId=6839335816ed, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Thu Aug 02 18:42:33 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-04 yangpeizhi

    #说明书#

    0

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    2018-08-03 易水河

    与时俱进啊

    0

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    2018-08-02 131****1460

    学习了受益匪浅

    0