Go homepage(回首页) Upload pictures (上传图片) Write articles (发文字帖)
The author:(作者)aaapublished in(发表于) 2013/12/16 0:44:29 Sichuan sheng， and pharmaceutical injection adverse event， was ordered halted
Authorities wide nets in Beijing, December 15 (reporter Shen Jingwen) according to the voice of the Yonge-Canton News reported, the State food and Drug Administration recently informed: Sichuan rose and pharmaceutical company limited Salvia adverse events.
From August this year, Sichuan rose and pharmaceutical company limited parts of the production batch is a single injection adverse events occurred in many provinces, chills, fever patients after the drugs appear to control security risks in a timely manner and prevent their recurrence, require companies to recall the corresponding batch medicine in Sichuan province, and find out why.
But Sichuan rose and pharmaceutical company limited recall measures are not effective, recalled product is not complete, and no risk control in a timely manner, resulting in some areas after many patients using similar incidents. Sichuan province has been interviewed about this enterprise, businesses halted and find out why. Companies exposed by this incident for the bad drugs perhaps for security breaches didn't pay enough attention to the insufficient knowledge may cause harm to patients, playing games, no risk of product recalls due to play control.
Bureau of food and Drug Administration to require all provinces will communicate the situation to the pharmaceutical production enterprises in the Bailiwick, and urge enterprises to draw lessons from the event, giving top priority to strengthen monitoring of adverse drug reactions, exposed the possible security implications of drugs to take effective risk control measures in a timely manner, to the convening of the products in question are determined completely prevent similar incidents from happening again.
In a bulletin issued after the Sichuan province food and drug authority has interviewed enterprises, businesses halted and find out why. Sichuan rose and medicine industry clinical Department Minister Yu Mr also to reporter said, company of Ministry of Commerce has is responsible for full recalled appeared bad reaction of single parameter injection, except recalled 10 ml of single parameter injection, Sichuan rose and medicine industry Corporation also will timely to regulatory sector report 10 ml single parameter injection of recalled dynamic situation, further find occurred bad reaction of reasons, perfect company bad reaction monitoring system and products recalled system of systematic construction.
(Original title: Sichuan sheng, and pharmaceutical injection adverse events were ordered into full production)
央广网北京12月15日消息（记者沈静文）据中国之声《央广新闻》报道，国家食药监管总局日前通报：四川升和药业股份有限公司丹参注射液发生不良事件。
从今年8月以来，四川升和药业股份有限公司生产的部分批次单参注射液先后在多个省份发生了不良事件，多名患者用药后出现寒战、发热为了及时控制安全隐患，防止事件重复发生，四川省局要求企业召回相应批次药品，并查找原因。
但是四川升和药业股份有限公司召回措施不得力，召回产品不彻底，以至没有及时控制风险，造成又有个别地区多名患者使用后发生类似事件。对此四川省局已约谈企业，要求企业全面停产并深入查找原因。这一事件暴露出企业对于该不良提示的药品可能存在的安全隐患没有引起足够重视，对可能对患者造成的危害认识不足，敷衍塞责，没有发挥产品召回应有的风险控制作用。
食药监管总局要求各省区市局将有关情况通报给辖区药品生产企业，督促企业从事件中汲取教训，举一反三加强药品不良反应的监测，对暴露出可能存在安全隐患的药品要及时采取切实有效的风险控制措施，对发生问题产品要坚决彻底的召开杜绝类似事件再次发生。
在这一通报发出之后四川省食药监管局已约谈企业，要求企业全面停产并深入查找原因。四川升和药业临床部部长于先生也向记者表示，公司的商务部已负责全面召回出现不良反应的单参注射液，除了召回10毫升的单参注射液，四川升和药业股份有限公司还将及时向监管部门报告10毫升单参注射液的召回动态情况，进一步查找发生不良反应的原因，完善公司不良反应监控体系和产品召回体系的系统化建设。
（原标题：四川升和药业注射液现不良事件 被勒令全面停产）
赞