注意：6岁以下儿童禁用
<p style="text-align: center;"></p><p><br/></p><section data-role="outer" label="edit by 135editor" style="letter-spacing: 1px;line-height: 2;font-family:微软雅黑;" data-mpa-powered-by="yiban.io" class=""><section data-role="paragraph"><section data-support="96编辑器" data-style-id="60723"><section><section><section class=""><section style="margin-top: 5px; margin-bottom: 10px; letter-spacing: 0.578px;"><section style="width: 578.171px;height: 5px;background-color: rgb(0, 112, 192);box-sizing:border-box;"><section><svg viewbox="0 0 1 1" style="float: left;line-height: 0;width: 0px;vertical-align: top;box-sizing:border-box;" xml:space="default"></svg></section></section></section><section style="margin-bottom: 10px; letter-spacing: 0.578px; line-height: 2em;"><section style="padding: 16px 20px;display: inline-block;width: 578.171px;vertical-align: top;background-color: rgba(199, 230, 255, 0.33);box-sizing:border-box;" class=""><section style="font-size: 17px;color: #5e5e5e;line-height: 1.8;letter-spacing: 1px;" class=""><p style="letter-spacing: 0.578px; line-height: 2em;"><span style="color: rgb(0, 0, 0); letter-spacing: 1px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">国家药品监督管理局近日发布公告，决定对炎琥宁注射剂（包括注射用炎琥宁、炎琥宁注射液、炎琥宁氯化钠注射液）说明书进行修订。</span></p><p style="letter-spacing: 0.578px;"><br/></p><p style="letter-spacing: 0.578px; line-height: 2em;"><span style="letter-spacing: 1px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;"><span style="color: rgb(0, 0, 0);">此次修订的核心内容是增加了黑框警告，明确指出</span><span style="color: rgb(0, 112, 192);"><strong>「接受本品治疗的患者有发生严重过敏反应的风险，包括过敏性休克，严重者可导致死亡。6岁及以下儿童禁用本品」。</strong></span></span></p></section></section></section></section></section></section></section></section><h2 style="line-height: 1.75em; text-align: center; margin-top: 16px; font-size: 17px;;line-height:2em"><span style="color: rgb(0, 112, 192); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">国家药监局关于修订</span></h2><h2 style="line-height: 1.75em; text-align: center; font-size: 17px;;line-height:2em"><span style="color: rgb(0, 112, 192); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">炎琥宁注射剂说明书的公告</span></h2><h2 style="line-height: 1.75em; text-align: center; margin-bottom: 16px; font-size: 17px;;line-height:2em"><span style="color: rgb(0, 112, 192); font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">（2025年第23号）</span></h2><h2 style="font-size:17px;"></h2><section data-role="outer" label="edit by 135editor"><section data-tools="135编辑器" data-id="156357" class="_135editor"><section style="margin: 10px auto;"><section style="width: 100%;height: 5px;background-image: linear-gradient(to right, rgb(0, 112, 192), rgb(144, 177, 240));background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;box-sizing:border-box;max-width:100% !important;" data-width="100%"><br/></section><section style="border-width: 1px;border-style: solid;border-color: rgb(202, 202, 202);padding: 20px 12px;box-sizing:border-box;"><section data-autoskip="1" style="line-height: 1.75em; letter-spacing: 1.5px; color: rgb(51, 51, 51);" class=""><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对炎琥宁注射剂（包括注射用炎琥宁、炎琥宁注射液、炎琥宁氯化钠注射液）说明书内容进行统一修订。现将有关事项公告如下：<br/></span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">一、所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照附件要求修订说明书，于2025年6月4日前报省级药品监督管理部门备案。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换或以其他形式将说明书更新信息告知患者，并应在本公告发布后及时将黑框警告内容告知患者和使用单位。对于集中采购中选品种，应确保集采供货药品附以更新的说明书和标签。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">二、药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师合理用药。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">三、临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">四、患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">五、省级药品监督管理部门应当督促行政区域内上述药品的上市许可持有人按要求做好相应说明书修订和标签、说明书更换工作，对违法违规行为依法严厉查处。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">特此公告。</span></p><p style="line-height: 2em;"><br/></p><p style="line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">附件：炎琥宁注射剂说明书修订要求</span></p></section></section><section style="width: 97%;height: 4px;background-color: rgb(240, 240, 240);margin-right: auto;margin-left: auto;box-sizing:border-box;max-width:97% !important;" data-width="97%"><br/></section></section></section></section><section data-role="outer" label="edit by 135editor"><section data-tools="135编辑器" data-id="156421" class="_135editor"><section style="margin: 10px auto;line-height: 1.75em;"><section style="display: flex;justify-content: center;"><section><section style="width: 60px;margin-left: auto;margin-bottom: -35px;margin-right: -20px;height: 0px;box-sizing:border-box;"><br/></section></section></section></section></section></section><section data-role="outer" label="edit by 135editor"><section><section class=""><section style="margin-top: 10px; outline: 0px; letter-spacing: 0.544px; background-color: rgb(255, 255, 255); color: rgb(34, 34, 34); justify-content: flex-start; display: flex; flex-flow: row; visibility: visible; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif;"><section style="margin-right: 10px;outline: 0px;display: inline-block;vertical-align: top;width: auto;flex: 100 100 0%;height: auto;align-self: flex-start;visibility: visible;box-sizing:border-box;"><section style="margin-top: 20px;margin-bottom: 8px;outline: 0px;visibility: visible;"><section style="outline: 0px;background-color: #43a6d7;height: 1px;visibility: visible;"><svg viewbox="0 0 1 1" style="float: left;line-height: 0;width: 0px;vertical-align: top;visibility: visible;box-sizing:border-box;" xml:space="default"></svg></section></section></section><section style="outline: 0px;display: inline-block;vertical-align: top;width: auto;min-width: 10%;flex: 0 0 auto;height: auto;align-self: flex-start;visibility: visible;box-sizing:border-box;"><section style="outline: 0px;justify-content: flex-start;display: flex;flex-flow: row;visibility: visible;"><section style="padding: 7px;outline: 0px;display: inline-block;width: 242px;vertical-align: top;background-color: #dbe5f1;align-self: flex-start;flex: 0 0 auto;visibility: visible;box-sizing:border-box;" class=""><section style="outline: 0px;text-align: center;visibility: visible;"><section style="outline: 0px;color: #ffffff;visibility: visible;" class=""><p style="outline: 0px; visibility: visible; line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;"><strong style="letter-spacing: 0.544px;font-size: var(--articleFontsize);outline: 0px;visibility: visible;"><span style="outline: 0px; color: rgb(0, 112, 192); text-decoration-style: solid; text-decoration-color: rgb(0, 112, 192); visibility: visible; letter-spacing: 1px;">附件：炎琥宁注射剂说明书</span></strong></span></p><p style="outline: 0px; visibility: visible; line-height: 2em;"><span style="letter-spacing: 1px; font-size: 17px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;"><strong style="letter-spacing: 0.544px;font-size: var(--articleFontsize);outline: 0px;visibility: visible;"><span style="outline: 0px; color: rgb(0, 112, 192); text-decoration-style: solid; text-decoration-color: rgb(0, 112, 192); visibility: visible; letter-spacing: 1px;">修订要求</span></strong></span></p></section></section></section></section><section style="outline: 0px;text-align: center;visibility: visible;"><section style="outline: 0px;display: inline-block;vertical-align: top;overflow: hidden;height: 10px;width: 200.854px;background-color: #dff5ff;visibility: visible;box-sizing:border-box;" class=""><svg viewbox="0 0 1 1" style="float: left;line-height: 0;width: 0px;vertical-align: top;visibility: visible;box-sizing:border-box;" xml:space="default"></svg></section></section></section><section style="margin-left: 10px;outline: 0px;display: inline-block;vertical-align: top;width: auto;flex: 100 100 0%;height: auto;align-self: flex-start;visibility: visible;box-sizing:border-box;"><section style="margin-top: 20px;margin-bottom: 8px;outline: 0px;visibility: visible;"><section style="outline: 0px;background-color: #43a6d7;height: 1px;visibility: visible;"><br style="outline: 0px;"/></section></section></section></section><p style="text-align:center; -webkit-tap-highlight-color: transparent; outline: 0px; letter-spacing: 0.544px; background-color: #ffffff; cursor: text; visibility: visible; max-inline-size: 100%; line-height: 2em;font-family:system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif;"></p></section></section></section></section><p style="overflow-wrap: break-word; margin-top: 0px; margin-bottom: 0px; padding: 0px; font-family: -apple-system-font, Helvetica, PingFang SC, Hiragino Sans GB, Arial, Microsoft YaHei; text-wrap: wrap; color: rgb(62, 62, 62); font-size: 17px; letter-spacing: 1px; text-align: justify; background-color: rgb(255, 255, 255); box-sizing: border-box;"><span style="overflow-wrap: break-word !important; font-size: 14px; color: rgb(136, 136, 136); letter-spacing: 0.544px; margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box;"></span></p><hr/><p style="overflow-wrap: break-word; margin-top: 0px; margin-bottom: 0px; padding: 0px; font-family: -apple-system-font, Helvetica, PingFang SC, Hiragino Sans GB, Arial, Microsoft YaHei; text-wrap: wrap; color: rgb(62, 62, 62); font-size: 17px; letter-spacing: 1px; text-align: justify; background-color: rgb(255, 255, 255); box-sizing: border-box;"><span style="color: rgb(136, 136, 136); font-size: 14px; letter-spacing: 0.544px;">来源：湖北发布 国家药品监督管理局</span></p><p style="margin-top: 0cm; margin-bottom: 0px; padding: 0px; color: rgb(67, 74, 84); font-family: -apple-system-font, Helvetica, PingFang SC, Hiragino Sans GB, Arial, Microsoft YaHei; text-wrap: wrap; font-size: 17px; text-align: justify; background-color: rgb(255, 255, 255); outline: 0px; max-width: 100%; clear: both; min-height: 1em; letter-spacing: 0.544px; line-height: 19.2pt; box-sizing: border-box; overflow-wrap: break-word !important;"><span style="overflow-wrap: break-word; font-size: 14px; box-sizing: border-box;"><span style="overflow-wrap: break-word !important; margin: 0px; padding: 0px; outline: 0px; max-width: 100%; letter-spacing: 0.544px; color: rgb(136, 136, 136); box-sizing: border-box;">制作：汪千 | </span><span style="overflow-wrap: break-word !important; margin: 0px; padding: 0px; outline: 0px; max-width: 100%; color: rgb(136, 136, 136); letter-spacing: 0.544px; box-sizing: border-box;">编辑：熊霞 | </span><span style="overflow-wrap: break-word !important; margin: 0px; padding: 0px; outline: 0px; max-width: 100%; letter-spacing: 0.544px; color: rgb(136, 136, 136); box-sizing: border-box;">责编：方军 </span></span></p><p style="margin-top: 0cm; margin-bottom: 0px; padding: 0px; color: rgb(67, 74, 84); font-family: -apple-system-font, Helvetica, PingFang SC, Hiragino Sans GB, Arial, Microsoft YaHei; text-wrap: wrap; font-size: 17px; text-align: justify; background-color: rgb(255, 255, 255); outline: 0px; max-width: 100%; clear: both; min-height: 1em; letter-spacing: 0.544px; line-height: 19.2pt; box-sizing: border-box; overflow-wrap: break-word !important;"><span style="overflow-wrap: break-word !important; font-weight: 700; letter-spacing: 0.544px; line-height: 19.2pt; margin: 0px; padding: 0px; outline: 0px; max-width: 100%; color: rgb(136, 136, 136); font-size: 14px; box-sizing: border-box;">出品：蔡甸区融媒体中心</span></p><p style="margin-top: 0cm; margin-bottom: 0px; padding: 0px; color: rgb(67, 74, 84); font-family: -apple-system-font, Helvetica, PingFang SC, Hiragino Sans GB, Arial, Microsoft YaHei; text-wrap: wrap; font-size: 17px; text-align: justify; background-color: rgb(255, 255, 255); outline: 0px; max-width: 100%; clear: both; min-height: 1em; letter-spacing: 0.544px; line-height: 19.2pt; box-sizing: border-box; overflow-wrap: break-word !important;"><br data-filtered="filtered" style="overflow-wrap: break-word;"/></p><p style="margin-top: 0cm; margin-bottom: 0px; padding: 0px; color: rgb(67, 74, 84); font-family: -apple-system-font, Helvetica, PingFang SC, Hiragino Sans GB, Arial, Microsoft YaHei; text-wrap: wrap; font-size: 17px; background-color: rgb(255, 255, 255); outline: 0px; max-width: 100%; clear: both; min-height: 1em; letter-spacing: 0.544px; line-height: 19.2pt; text-align: center; box-sizing: border-box; overflow-wrap: break-word !important;"><span style="overflow-wrap: break-word !important; 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