中新社南昌1月27日电 (记者 刘占昆)江西省食品药品监督管理局27日在南昌表示，江西铜鼓仁和制药有限公司生产的小儿氨酚烷胺颗粒“优卡丹”产品，其新修订的药品说明书已经该局批准，并报国家食品药品监管局备案，该药品可正常销售和使用。

China news agency on January 27, nanchang (Reporter LiuZhanKun)Jiangxi province food and drug administration, 27, said in nanchang,Jiangxi tonggu kernel and pharmaceutical co., LTD. Is the production of pediatric ammonia phenol paraffin amine particles"Optimal espace cardin"products,The new revision of the drug instruction has been approved by the bureau,And report to the state food and drug supervision bureau for the record,The drug can normal sale and use.

　　近日，有网友爆料“著名演员宋丹丹代言的优卡丹会损害儿童肝肾”，该事件立即成为众多民众热议的焦点。

recently,Netizens kept"The famous actor BTV, speak of optimal espace cardin can damage children's liver and kidney",The events immediately became the focus of many people of hot debate.

　　作为该药品代言人的宋丹丹25日在其实名微博发布消息称，“如网上爆料属实，我将诚恳地通过媒体站出来道歉。由于个人无法确切了解及掌握药检质量，今后无论是否有药检部门的审批资格，我都将不会再代言任何药品类广告！”

As the drug's spokesperson BTV, 25 in actually name micro bo said in a news release said,"Such as Internet blog is true,I will sincerely apologize stand out through the media.Due to the individual cannot know exactly and master drug test quality,In the future regardless of whether any drug test department approval qualification,I will no longer speak any drug ads!"

　　优卡丹官方26日发表声明，澄清“会对儿童肝肾功能造成损害”的传言，称“1-12岁儿童依据说明书可放心使用，不会对肝肾功能造成损害，1岁以下婴幼儿禁服，但原因非肝肾毒性”。

Optimal espace cardin 26 official statement,clarification"On children's liver/kidney damage"rumors,says"1-12 years old children according to the specification can be at ease use,Will not cause damage to liver and kidney function,Infants under one year of age the suit,But cause the kidney toxicity".

　　江西省食品药品监督管理局新闻办负责人27日接受中新社记者采访表示，2012年5月，国家食品药品监督管理局下发了《关于修订含盐酸金刚烷胺的非处方药说明书的通知》，对所有含盐酸金刚烷胺成分的儿童非处方药品说明书进行修订，要求生产企业接通知后，尽快修改该类产品的说明书。

Jiangxi food and drug administration office chief 27 accept China news agency reporters said,In May 2012,State food and drug administration issued[About the revised YanSuanJinGangWanAn containing the otc drug instruction notice],For all YanSuanJinGangWanAn composition containing children over-the-counter medicines to revise,Request production enterprise joint notification,As soon as possible the product specifications.

　　该通知要求，在药品说明书“禁忌”项中增加“因缺乏新生儿和1岁以下婴儿安全性和有效性的数据，新生儿和1岁以下婴儿禁用本品”。“用法用量”项未作调整，1-12岁儿童可按说明书正常使用。

The notice requirements,In a written description of the drug"taboo"Item increase"Due to lack of newborn babies under one year of age and the safety and effectiveness of data,Newborn babies under one year of age and disable this product"."Usage and dosage"Item was not made adjust,1-12 years old children according to specification of normal use.

　　“修改药品说明书是正常的药品监管工作，不是质量问题。”该负责人表示，食品药品监管部门对含盐酸金刚烷胺成分用药说明书的修订，是对该类药品再评价后的普遍规定，并非针对江西铜鼓仁和制药有限公司的小儿氨酚烷胺颗粒“优卡丹”产品的个别要求，更不是药品质量出现问题。

"Modified drug instruction is normal drug supervision work,Not quality problem."This person in charge said,The food and drug supervision department of YanSuanJinGangWanAn composition containing drug manual revision,This is the drug again after the evaluation, a general rule,Is not aimed at jiangxi tonggu kernel and pharmaceutical co., LTD. Of pediatric ammonia phenol paraffin amine particles"Optimal espace cardin"The product of individual requirements,More is not a drug quality problems.

　　江西省食品药品监督管理局提醒，对于非处方药，消费者应当仔细阅读说明书并按说明使用或在药师的指导下购买和使用。(完)

Jiangxi food and drug administration to remind,For otc drug,Consumers should read the instructions carefully and use according to the instructions or in the medicine under the guidance of the purchase and use.(finish)