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class="col__wrapper"><div class="zz-comp zz-comp-list-outer _141ud3stgo005" data-type="list" data-mount-_141ud3stgo005 data-source="newSource" id="_141ud3stgo005"><div class="zz-comp-list num1"><ul class="zz-comp-list__wrap"><li class="zz-comp-list__item wow fadeIn is-grid __item" data-wow-iteration="1" data-wow-delay="0.12s" data-wow-duration="2.90s"><div class="time-bottom zz-element-wrapper" data-class="x-router-link" data-lightbox data-stick><div class="img" style="padding-top: 90.47619047619048%;"><div class="img-wrapper"><div class="do-img-cover img-0"><img class="lazyload object-fit-cover" data-index="0" data-src="http://p.cdn-static.cn/34527_159845688815322.jpg?imageView2/2/w/724/q/75" title="圖文組件" alt="圖文組件"/></div></div></div></div></li></ul></div></div></div><div class="zz-bg"><div class="zz-bg-color"></div></div></div></div><div class="zz-column zz-col-1 zz-col-sm-1 zz-col-xs-12"><div class="zz-comp zz-comp-col _141ud3stgo006" data-type="col" id="_141ud3stgo006"><div class="col__wrapper"></div><div class="zz-bg"><div class="zz-bg-color"></div></div></div></div><div class="zz-column zz-col-5 zz-col-sm-5 zz-col-xs-12"><div class="zz-comp zz-comp-col _141ud3stgo007" data-type="col" id="_141ud3stgo007"><div class="col__wrapper"><div class="zz-comp zz-comp-gap _141ud3stko000" data-type="gap"></div><div class="zz-comp zz-comp-text clearfix _141ud3stko001" data-type="text" id="_141ud3stko001"><div class="zz-text zz-comp-content" data-class="x-router-link"><div><p><strong><span style="font-size: 24pt;">靜注人免疫球蛋白（pH4）</span></strong></p></div></div></div><div class="zz-comp zz-comp-gap _141ud3stko002" data-type="gap"></div><div class="zz-comp zz-comp-text clearfix _141ud3stko003" data-type="text" id="_141ud3stko003"><div class="zz-text zz-comp-content" data-class="x-router-link"><div><p><span style="font-size: 16px; color: #000000;"><strong>【藥品名稱】<br /></strong>通用名稱：靜注人免疫球蛋白（pH4）<br />英文名稱：Human Immunoglobulin（pH4）for Intravenous Injection <br />漢語拼音：Jingzhu Ren Mianyiqiudanbai(pH4)<strong><br />【成份】<br /></strong>主要組成成份：本品蛋白質中95%以上為人免疫球蛋白。輔料：麥芽糖。<strong><br />【性狀】<br /></strong>無色或淺黃色澄明液體，可帶輕微乳光。</span></p></div></div></div><div class="zz-comp zz-comp-gap _141ud3stko004" data-type="gap"></div></div><div class="zz-bg"><div class="zz-bg-color"></div></div></div></div><div class="zz-column zz-col-1 zz-col-sm-1 zz-col-xs-12"><div class="zz-comp zz-comp-col _141ud3stko005" data-type="col" id="_141ud3stko005"><div class="col__wrapper"></div><div class="zz-bg"><div class="zz-bg-color"></div></div></div></div></div></div><div class="zz-comp zz-comp-gap _141ud3stko006" data-type="gap"></div><div class="zz-comp zz-comp-text clearfix _141udpf90o000" data-type="text" id="_141udpf90o000"><div class="zz-text zz-comp-content" data-class="x-router-link"><div><p><strong>【</strong><strong>適應癥</strong><strong>】</strong></p> <p>1.原發性免疫球蛋白缺乏癥，如X聯鎖低免疫球蛋白血癥，常見變異性免疫缺陷病，免疫球蛋白G亞型缺陷病等。</p> <p>2.繼發性免疫球蛋白缺陷病，如重癥感染，新生兒敗血癥等。</p> <p>3.自身免疫性疾病，如原發性血小板減少性紫癜，川崎病。</p> <p><strong>【</strong><strong>規格</strong><strong>】</strong></p> <p>1.25g/瓶，5% 2.5g/瓶，5% 5g/瓶，5% 10g/瓶，5% </p> <p><strong>【用法用量】</strong></p> <p>用法：靜脈滴注或以5%葡萄糖溶液稀釋1～2倍作靜脈滴注，開始滴注速度為1.0ml/分（約20滴/分），持續15分鐘后若無不良反應，可逐漸加快速度，最快滴注速度不得超過3.0ml/分（約60滴/分）。兒童滴速酌情減慢。</p> <p>用量：遵醫囑。推薦劑量：<br /> 1.原發性免疫球蛋白缺乏或低下癥：首次劑量：400mg/kg體重；維持劑量：200～400mg/kg體重，給藥間隔時間視病人血清IgG水平和病情而定，一般每月一次。<br /> 2.原發性血小板減少性紫癜：每日400mg/kg體重，連續5日；維持劑量每次400mg/kg體重，間隔時間視血小板計數和病情而定，一般每周一次。<br /> 3.重癥感染：每日200～300mg/kg體重，連續2～3日。<br /> 4.川崎?。喊l病10日內應用，兒童治療劑量2.0g/kg體重，一次輸注。</p> <p><strong>【</strong><strong>不良反應</strong><strong>】</strong></p> <p>1.國外臨床試驗</p> <p>同類的國外上市產品在超過5%的臨床試驗受試者中觀察到以下常見不良反應：頭痛、寒戰、發熱、疼痛、乏力、背痛、惡心、嘔吐、腹痛、腹瀉、輸液部位反應、皮疹、瘙癢、蕁麻疹、高血壓、低血壓、心動過速等。</p> <p>2.國內上市后監測</p> <p>本品及同類的國內上市產品監測到如下不良反應/事件，由于這些不良反應/事件是在無法確定總數的人群中自發報告的，因此不能準確估算其發生率：</p> <p>（1）全身性損害：畏寒、高熱、胸痛、不適、蒼白、乏力、眶周水腫、水腫、全身酸痛等。</p> <p>（2）皮膚及其附件損害：斑丘疹、紅斑性皮疹、局限性皮膚反應、表皮松解、多發性紅斑、皮炎（如大皰性皮炎）、出汗增加等。</p> <p>（3）免疫功能紊亂和感染：過敏反應、過敏樣反應、輸液反應、過敏性休克等。</p> <p>（4）心血管系統損害：紫紺、心悸、高血壓、心律失常等。</p> <p>（5）神經系統損害：頭暈、昏迷、意識喪失、震顫、肌肉不自主收縮、感覺減退等。</p> <p>（6）呼吸系統損害：呼吸困難、呼吸急促、呼吸暫停、喘息、喉頭水腫、呼吸功能不全、輸血相關急性肺損傷、低氧血癥等。</p> <p>（7）血管損害和出凝血障礙：潮紅、靜脈炎等。</p> <p>（8）精神障礙：激越、精神障礙、嗜睡等。</p> <p>（9）代謝和營養障礙：高血糖。（注：藥品成份中含糖類的，注明此項）</p> <p>（10）血液系統損害：白細胞減少、中性粒細胞減少、粒細胞缺乏等。</p> <p>3.國外上市后監測</p> <p>同類的國外上市產品還監測到如下不良反應/事件，由于這些不良反應/事件是在無法確定總數的人群中自發報告的，因此不能準確估算其發生率：</p> <p>（1）皮膚及其附件損害：史蒂文斯-約翰遜綜合征等。</p> <p>（2）神經系統損害：癲癇發作、無菌性腦膜炎等。</p> <p>（3）呼吸系統損害：急性呼吸窘迫綜合征、肺水腫、支氣管痙攣等。</p> <p>（4）血管損害和出凝血障礙：血栓形成等。</p> <p>（5）血液系統損害：血漿黏度增加、溶血反應等。</p> <p>（6）泌尿系統損害：腎功能損害等。</p> <p>上述不良反應部分可能與輸注速度過快或個體差異有關。建議在輸注的全過程定期觀察病人的一般情況和生命特征，必要時減慢或暫停輸注，一般無需特殊處理即可自行恢復。個別病人可在輸注結束后發生上述反應，一般在24小時內均可自行恢復。</p> <p><strong>【</strong><strong>禁忌</strong><strong>】</strong></p> <p>1.對人免疫球蛋白過敏或有其他嚴重過敏史者。</p> <p>2.有IgA抗體的選擇性IgA缺乏者。</p> <p><strong>【</strong><strong>注意事項</strong><strong>】</strong></p> <p>1.監測急性腎功能衰竭患者的腎功能，包括血尿素氮、血肌酐和尿量。對于腎功能不全或衰竭的患者，要以最小的速度輸注。易感患者使用本品可能引起腎功能異常。使用含蔗糖的本品患者，更易引起腎功能異常和急性腎功能衰竭。</p> <p>2.可能發生血栓性事件。監測有血栓形成事件已知危險因素的患者；對有高粘血癥風險患者的血液粘度進行基線評估。對于有血栓形成風險的患者，要在最小劑量下緩慢輸注。</p> <p>3.可能發生無菌性腦膜炎綜合征，特別是在高劑量或快速輸注時。</p> <p>4.可能發生溶血性貧血。監測溶血和溶血性貧血患者的臨床體征和癥狀。</p> <p>5.本品專供靜脈輸注用。</p> <p>6.如需要，可以用5%葡萄糖溶液稀釋本品，但糖尿病患者應慎用。</p> <p>7.藥液呈現混濁、沉淀、異物或瓶子有裂紋、過期失效,不得使用。</p> <p>8.本品開啟后,應一次輸注完畢,不得分次或給第二人輸用。</p> <p>9.有嚴重酸堿代謝紊亂的病人應慎用。</p> <p><strong>【孕婦及哺乳期婦女用藥】</strong></p> <p>對孕婦或可能懷孕婦女的用藥應慎重，如有必要應用時，應在醫師指導和嚴密觀察下使用。</p> <p><strong>【兒童用藥】</strong></p> <p>未進行該項研究且無可靠參考文獻。</p> <p><strong>【老年用藥】</strong></p> <p>未進行該項試驗研究，且無系統可靠的參考文獻。在65歲以上的患者中，一般情況下，不超過推薦劑量，緩慢輸注。</p> <p><strong>【藥物相互作用】</strong></p> <p>本品應單獨輸注，不得與其他藥物混合輸用。</p> <p><strong>【藥物過量】</strong></p> <p><strong> </strong>未進行該項研究且無可靠參考文獻。</p> <p><strong>【</strong><strong>藥理毒理</strong><strong>】</strong></p> <p>本品含有廣譜抗病毒、細菌或其他病原體的IgG抗體，另外免疫球蛋白的獨特型和獨特型抗體能形成復雜的免疫網絡，所以具有免疫替代和免疫調節的雙重治療作用。經靜脈輸注后，能迅速提高受者血液中的IgG水平，增強機體的抗感染能力和免疫調節功能。</p> <p><strong>【藥代動力學】</strong></p> <p>本品是從人血漿中分離、純化制成，經靜脈注射后，血漿中IgG水平迅速達到峰值（15分鐘），半衰期3～4周。</p> <p><strong>【</strong><strong>貯藏</strong><strong>】</strong></p> <p>2~8℃避光保存和運輸，嚴防凍結。</p> <p><strong>【包裝】</strong></p> <p>玻璃瓶裝，1玻璃瓶/盒</p> <p><strong>【有效期】</strong></p> <p>36個月</p> <p><strong>【執行標準】</strong></p> <p> 《中國藥典》2020年版三部</p> <p><strong>【</strong><strong>批準文號</strong><strong>】</strong></p> <p>國藥準字S19993038 國藥準字S19993037 </p> <p>國藥準字S20053075 國藥準字S20053074 </p> <p><strong>【</strong><strong>生產企業</strong><strong>】</strong></p> <p>企業名稱：浙江?？瞪镏破酚邢挢熑喂?/p> <p>企業地址：浙江省溫州市里垟新路28號</p> <p>郵編：325000</p> <p>電話：0577-88638565</p> <p>傳真：0577-88638565</p> <p>網址：www.alladdy.com</p> <p> </p> <p> </p> <p> </p></div></div></div></div></div><div class="zz-bg"><div class="zz-bg-color"></div></div></div></div><div class="zz-page-footer-comp" data-type="layout" data-layout-id="_13vktls3ko000"><div class="zz-comp zz-comp-block-wrap flex-auto _13vktls34o001" data-type="block-wrap" data-layout-id="_13vktls3ko000" id="block-footer-0"><div class="zz-container"><div class="zz-comp zz-comp-block" 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