| <SPAN><STRONG> </STRONG></SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">FDA2009年5月7日</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>提醒医护人员有两种外用睪固酮凝胶的处方药</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">AndroGel1% </SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>和</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">Testim1%</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>的说明书需新增加框警语。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">AndroGel1%</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>和</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">Testim1%</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>被用于无法自行分泌睪固酮或睪固酮分泌量不足的男性，</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>现已接到八例儿童间接暴露于睾固醇凝胶的不良反应报告，这些儿童的年齡从九个月到五岁不等。综合某些较完整的案例发现，这些儿童发生的不良反应包括生殖器异常肥大、阴毛提早发育、骨龄增加、性欲增加及好斗行为。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体; mso-hansi-font-family: " Roman?? New Times ?Times mso-ascii-font-family: Roman?;>已提供使用建议和警语，希望能降低儿童间接暴露的发生率。</SPAN> |
