皇冠体育在线_皇冠体育网-【官方网站】@

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 216pt; LINE-HEIGHT: 150%; mso-char-indent-count: 18.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">国食药监注<SPAN lang=EN-US>[2012]93</SPAN>号<SPAN lang=EN-US><SPAN style="mso-spacerun: yes">&nbsp; </SPAN><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 0cm; LINE-HEIGHT: 150%; mso-char-indent-count: 0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">各省、自治区、直辖市食品药品监督管理局<SPAN lang=EN-US>(</SPAN>药品监督管理局<SPAN lang=EN-US>)</SPAN>：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">根据不良反应评估结果，为控制药品使用风险，决定对香丹注射液的说明书进行修订。现将有关事项通知如下：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">一、香丹注射液说明书按照所附说明书修订要求进行修订。说明书的其他内容，应与原批准内容一致。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">二、请通知行政区域内药品生产企业尽快修订说明书和标签、按照有关规定进行备案。自补充申请批准之日起出厂的药品不得再使用原药品说明书。药品生产企业还应主动跟踪该类药品临床应用的安全性情况，按规定收集不良反应并及时报告。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">三、药品生产企业应当将修订的内容及时通知相关医疗机构、药品经营企业等单位，并尽快对已出厂的药品说明书予以更换。由于未及时更换说明书而引起的不良后果，由药品生产企业负责。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">附件：香丹注射液说明书修订要求<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　　　　　　　　　　　　　　　　　　　　　　　　　　　　国家食品药品监督管理局<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　　　　　　　　　　　　　　　　　　　　　　　　　　　　二○一二年三月三十日<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">附件：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　　　　　　　　　　　　　　香丹注射液说明书修订要求<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">一、应增加警示语，内容如下：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　警示语：本品不良反应包括过敏性休克，应在有抢救条件的医疗机构使用，用药后出现过敏反应或其他严重不良反应应立即停药并及时救治。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">二、【不良反应】项应当包括：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　全身性损害：过敏样反应、过敏性休克、紫绀、发热、寒战、晕厥等。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　呼吸系统损害：呼吸困难、胸闷、咳嗽、喘憋、喉水肿等。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　心血管系统损害：心悸。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　中枢及外周神经系统损害：头晕、头痛。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　皮肤及其附件损害：皮疹、瘙痒。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　胃肠系统损害：恶心、呕吐。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">三、【禁忌】项应当包括：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>1</SPAN>．对本品或含有丹参、降香制剂有过敏或严重不良反应病史者禁用。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>2</SPAN>．本品含有聚山梨酯<SPAN lang=EN-US>-80</SPAN>，对聚山梨酯<SPAN lang=EN-US>-80</SPAN>类制剂过敏者禁用。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>3</SPAN>．孕妇及哺乳期妇女禁用。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">四、【注意事项】项应当包括：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>1</SPAN>．本品不良反应包括过敏性休克，应在有抢救条件的医疗机构使用，用药后出现过敏反应或其他严重不良反应应立即停药并及时救治。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>2</SPAN>．严格按照药品说明书规定的功能主治使用，禁止超功能主治用药。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>3</SPAN>．严格掌握用法用量及疗程。按照药品说明书推荐剂量、疗程使用药品。不超剂量和长期连续用药。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>4</SPAN>．用药前应仔细询问患者用药史和过敏史，对过敏体质者慎用。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>5</SPAN>．用药前应认真检查药品以及配置后的滴注液，发现药液出现浑浊、沉淀、变色、结晶等药物性状改变以及瓶身细微破裂者，均不得使用。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>6</SPAN>．药品稀释应严格按照说明书的要求配制，不得随意改变稀释液的种类、稀释浓度和稀释溶液用量。配药后应坚持即配即用，不宜长时间放置。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>7</SPAN>．严禁混合配伍，谨慎联合用药。中药注射液应单独使用，禁忌与其他药品混合配伍使用。谨慎联合用药，如确需要联合使用其他药品时，应谨慎考虑与中药注射剂的间隔时间以及药物相互作用等问题。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>8</SPAN>．对老人、儿童、肝肾功能异常患者等特殊人群和初次使用中药注射剂的患者应慎重使用，加强监测。对长期使用的在每疗程间要有一定的时间间隔。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">　<SPAN lang=EN-US>9</SPAN>．加强用药监护。用药过程中应缓慢滴注，同时密切观察用药反应，特别是开始<SPAN lang=EN-US>30</SPAN>分钟。如发现异常，应立即停药，采取积极措施救治患者。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 0cm; LINE-HEIGHT: 150%; mso-char-indent-count: 0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">抄送：总后勤部卫生部药品监督管理局、国家药典委员会、国家局药品审评中心、国家局信息中心。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>