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关于“阿司咪唑”(息斯敏)可能会引起严重不良反应的问题,国家食品药品监管局对此一直给予高度关注并对相关信息进行跟踪、调查和分析。2002年7月1日,国家药品不良反应监测中心已经通报了该药的安全隐患问题。国家食品药品监管局要求生产企业严密观察和监测该药品的不良反应,提示临床注意合理使用。 “阿司咪唑”是一种非镇静抗组胺药品(第二代抗过敏药),1988年由西安杨森制药有限公司在我国注册上市,并广泛应用于临床。过去临床主要用于治疗过敏性鼻炎、过敏性结膜炎、慢性寻麻疹和其他过敏性疾病。2004年2月13日,根据西安杨森制药有限公司修改药品说明书的申请,国家食品药品监管局批准对该药说明书的修改,适
Regarding the possibility of serious adverse reactions caused by “astemizole ” (astemizole), the State Food and Drug Administration has been paying close attention to and tracking, investigating and analyzing relevant information. July 1, 2002, the National Adverse Drug Reaction Monitoring Center has informed the drug’s safety problems. The State Food and Drug Administration requires manufacturers to closely observe and monitor the adverse drug reactions, suggesting that clinical attention to rational use. “Astemizole ” is a non-sedating antihistamines (second-generation anti-allergy drugs), in 1988 by the Xi’an Janssen Pharmaceutical Co., Ltd. registered in China and widely used in clinical. In the past the main clinical treatment for allergic rhinitis, allergic conjunctivitis, chronic hives and other allergic diseases. February 13, 2004, according to Xi’an Janssen Pharmaceutical Co., Ltd. to modify the application for drug specifications, the State Food and Drug Administration approval of the drug manual changes, suitable