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總局關于仙靈骨葆膠囊、仙靈骨葆片轉換為處方藥的公告(2017年第3號)

發布時間:2017-03-10 09:29:41 發布人:湖南楚濟堂

為保障公眾用藥安全,根據《處方藥與非處方藥分類管理辦法(試行)》(國家藥品監督管理局令第10號)的規定,經國家食品藥品監督管理總局組織論證和審定,將仙靈骨葆膠囊和仙靈骨葆片調出非處方藥目錄,按處方藥管理,同時對仙靈骨葆口服制劑說明書【不良反應】、【禁忌】和【注意事項】項進行修訂。現將有關事項公告如下:

  一、所有仙靈骨葆口服制劑生產企業均應依據《藥品注冊管理辦法》等有關規定,按照仙靈骨葆口服制劑說明書修訂要求(見附件),提出修訂說明書的補充申請,于2017217日前報省級食品藥品監管部門備案。
  修訂內容涉及藥品標簽的,應當一并進行修訂;說明書及標簽其他內容應當與原批準內容一致。在補充申請備案后6個月內對已出廠的藥品說明書及標簽予以更換。
  各仙靈骨葆口服制劑生產企業應當對新增不良反應發生機制開展深入研究,采取有效措施做好仙靈骨葆口服制劑使用和安全性問題的宣傳培訓,指導醫師合理用藥。

  二、臨床醫師應當仔細閱讀仙靈骨葆口服制劑說明書的修訂內容,在選擇用藥時,應當根據新修訂說明書進行充分的效益/風險分析。

  三、仙靈骨葆膠囊和仙靈骨葆片已被調出非處方藥目錄,按處方藥管理。自本公告發布之日起,藥品零售企業應憑處方銷售仙靈骨葆膠囊和仙靈骨葆片。患者應嚴格遵醫囑用藥,用藥前應仔細閱讀藥品說明書。

  四、各地要加強監督檢查,對發現的違法違規行為依法嚴厲查處,涉嫌犯罪的,移交公安機關追究刑事責任。

  特此公告。

  附件:仙靈骨葆口服制劑說明書修訂要求

 

食品藥品監管總局

2017年1月9


附件

 

仙靈骨葆口服制劑說明書修訂要求

 

一、【不良反應】項應包括:

本品可能引起以下不良反應:

1.過敏反應:皮疹、瘙癢等。

2.消化系統:惡心、嘔吐、納差、胃部不適、腹痛、腹瀉、便秘等。

3.肝臟:丙氨酸氨基轉移酶、天冬氨酸氨基轉移酶、膽紅素等升高,嚴重者可出現肝衰竭。

4.全身癥狀:乏力、外周水腫、尿色加深等。

二、【禁忌】項應包括:

1.孕婦禁用。

2.有肝病史或肝生化指標異常者禁用。

三、【注意事項】項應包括:

1.用藥期間應定期監測肝生化指標。

2.出現肝生化指標異常或全身乏力、食欲不振、厭油、惡心、上腹脹痛、尿黃、目黃、皮膚黃染等可能與肝損傷有關的臨床表現時,應立即停藥并到醫院就診。

3.本品應避免與有肝毒性的藥物聯合用藥。



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