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药监局:监测未发现云南白药严重不良反应报告--亲民维稳网络舆情监测室
2013-02-06

  中新网2月6日电 据国家食品药品监督管理局网站消息,国家食品药品监督管理局今天发布公告,对云南白药安全性问题表示关注。国家食品药品监督管理局表示,对云南白药的不良反应进行了监测,未发现严重的不良反应报告。

February 6, according to the state food and drug administration website news,State food and drug administration issued today,The safety of yunnan baiyao that focuses on.State food and drug administration said,Yunnan baiyao adverse reactions to the monitoring,Not found serious adverse reactions report.

  2013年2月5日,香港卫生署发出新闻公报,因云南白药散剂等5个品种含有未标示的乌头类生物碱,要求予以回收。

February 5th 2013,Hong Kong department of health issued news bulletin,For yunnan baiyao powder five varieties contain not labeled aconitum alkaloids,Asked to recovery.

  国家食品药品监督管理局表示,在此之前已注意到近期媒体对云南白药含乌头碱的关注,及时约谈了企业有关负责人,要求企业在遵守国家法律的同时,及时修改说明书,增加药品安全风险的提示内容,同时,加强上市产品的不良反应监测,确保用药安全。

State food and drug administration said,Before this has noticed the recent media to yunnan baiyao containing aconitine attention,Timely interviewed the enterprise relevant person in charge,Requests the enterprise abide by the state laws and at the same time,In time to amend the specification,Increase the risk of drug safety prompt content,At the same time,To strengthen the market adverse reactions monitoring,To ensure medication safety.

  国家食品药品监督管理局指出,云南白药是我国中医药传统品种。自1956 年以来,其配方、工艺被国家相关单位确定为国家秘密,严格保密。根据国家保密法律法规的有关规定,凡列入国家秘密技术项目的品种,其说明书、标签可不列成份项目。

The state food and drug administration said,Yunnan baiyao is China's traditional Chinese medicine varieties.Since 1956,The formula/Process by the national related units determined as state secrets,Strictly confidential.According to the national security the relevant provisions in laws and regulations,All listed in the national secret technology project varieties,The specification/Labels don't listed ingredients project.

  国家食品药品监督管理局批准的云南白药配方中含有乌头碱类物质的药材。其药材经过炮制,可使毒性大大降低。如果企业严格按照国家食品药品监督管理局批准的配方工艺以及药品生产质量管理规范(GMP)的要求组织生产,其产品总体是安全的。

State food and drug administration approved yunnan baiyao formula containing aconitine class material medicinal materials.The medicinal materials after processing,Can make the toxicity is greatly reduced.If the enterprise in strict accordance with the state food and drug administration approved technics and the quality control standard for pharmaceutical production(GMP)Organize production requirements,The overall product is safe.

  国家食品药品监督管理局称,对云南白药的不良反应进行了监测,未发现严重的不良反应报告。为进一步保障公众用药安全,国家食品药品监督管理局提醒公众,要在医生的指导下,严格按说明书使用云南白药,不要超剂量使用,不要长时间使用。如出现严重不良反应,应及时就医,并报告当地食品药品监管部门。

State food and drug administration said,Yunnan baiyao adverse reactions to the monitoring,Not found serious adverse reactions report.To further ensure the safety of medication,State food and drug administration to remind the public,In under the guidance of doctors,Strictly in accordance with the instructions to use yunnan baiyao,Don't use ultra dose,Don't use for a long time.If appear serious adverse reaction,Should be timely medical,And report to the local food and drug supervision department.


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