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食药监局更改茵栀黄口服制剂说明书 增腹泻等不良反应

2017-08-23 佚名 健康时报网

近日,国家食品药品监督管理总局发布公告,决定对茵栀黄口服制剂说明书【不良反应】和【注意事项】项进行修订。在不良反应中增加了腹泻、呕吐和皮疹等不良反应报告。国家食品药品监督管理总局在公告中说明,注意事项中增加以下内容:1.鉴于茵栀黄口服制剂有葡萄糖-6-磷酸脱氢酶(G6PD)缺乏患者发生溶血的个例,目前关联性尚无法确定,有待进一步研究,建议葡萄糖-6-磷酸脱氢酶(G6PD)缺乏者谨慎使用。2.脾虚大

近日,国家食品药品监督管理总局发布公告,决定对茵栀黄口服制剂说明书【不良反应】和【注意事项】项进行修订。在不良反应中增加了腹泻、呕吐和皮疹等不良反应报告。

国家食品药品监督管理总局在公告中说明,注意事项中增加以下内容:1.鉴于茵栀黄口服制剂有葡萄糖-6-磷酸脱氢酶(G6PD)缺乏患者发生溶血的个例,目前关联性尚无法确定,有待进一步研究,建议葡萄糖-6-磷酸脱氢酶(G6PD)缺乏者谨慎使用。2.脾虚大便溏者慎用。

公告明确了茵栀黄口服制剂为处方药,临床医师应当仔细阅读茵栀黄口服制剂说明书的修订内容,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。所有茵栀黄口服制剂生产企业均应依据《药品注册管理办法》等有关规定,按照茵栀黄口服制剂说明书修订要求(见附件),提出修订说明书的补充申请,于2017年9月29日前报省级食品药品监管部门备案。

国家食品药品监督管理总局同时要求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个月内对已出厂的药品说明书及标签予以更换。

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    2018-04-03 luwei00
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    2017-08-25 xuyu
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