關於somatropin(重組人生長激素)安全性的最新資訊 Latest safety update on somatotropin(recombinant human growth hormone)

        歐盟藥物管理局(EMA)發出通告, 指將會重新評估所有含somatropin(重組人生長激素)的藥物, 該藥用於治療多種生長激素缺乏的疾病。初步的數據顯示, 對於一般人群, 兒童時期使用somatropin(用於生長激素缺乏或不明原因的身體矮小)的病人, 其死亡風險會增加, 特別是在使用超出說明書所建議劑量的病人當中。目前, 在還未得出確定性的結論前, 建議嚴格按照說明書使用該藥。

備註:獲准在本澳市場供應somatropin的藥物包括Genlei JintropinHumatropeNorditropinSaizen以及 Scitropin

                                                                                                                                                    

       Recent safety alert from European Medicines Agency (EMA) announced her action to review all of the medications containing somatropin (recombinant human growth hormone), a drug indicated to treat various diseases associated with growth hormone deficiency.  Preliminary observation showed an elevated risk of mortality in patients who were being treated with somatropin (for growth hormone deficiency or short stature of unknown cause) during their childhood as compared with those in the general population. The risk appeared to be particularly enhanced when doses used exceeding that recommendation on the Summary of Product Characteristics. While pending for confirmation, it is recommended that physicians, pharmacists and other healthcare professionals strictly follow the instructions on the product information.

Notes:The brands of somatropin-containing medications available in the Macau market include Genlei Jintropin, Humatrope, Norditropin, Saizen and Scitropin.

 

參考資料/Reference and website:

https://www.ema.europa.eu/ema/index.jsp?curl=/pages/news_and_events/news/2010/12/news_detail_001160.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1


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