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                  ?/span>药品名称?/span>

                  逡用名称:重组乙型肝炎疫苗(汉逊酵母)

                  英文名称?/span>Recombinant Hepatitis B Vaccine(Hansenula Polymorpha )

                  汉语拼音?/span>Chongzu Yixing Ganyan Yimiao (Hanxun Jiaomu)

                  【成分和性状?/span>本品系由重组汉逊酵母表达的乙型肝炎病毒表面抗ӎ?/span>HBsAg)经纯化,加入铝佦ΐ剂后制成。为乳白色混悬液体,可因 沉淀而分层,易摇散。有效成刨:乙型肝炎病毒表面抗原?/span>辅料:ʽ氧化铝、氯化̒〡?/span>

                  【接ѾŶ种对象?/span>本疫苗适用于乙型肝炎ʱ䘓感者,尤其下列人员:(1)新生儿A特刢٫是母亲?/span>HBsAg?/span>HBeAg阳性者。(2)从事医疗工作的医护人员及桾触血液的实验人员?/span>

                  【作用与用途?/span>接种本疫苰쿡Ҳ后,可刺激机体产生抗乙垡肝炎病毒的免疫力。用于预防乙型肝炎żȴôҲ?/span>

                  【规     格?/span>每瓶(支?/span>0.5ml,每1次人用剂?/span>0.5ml, ?/span>HBsAg 10μg?/span>

                  【免疫程序和剂量?/span>?/span>1)于上臂三角肌肌内注射。(2)免疫程序为3针,分别?/span>0?/span>1?/span>6月接种,新生儿在凡ɺ生?/span>24小时内ѳ射ơ1针,ɷ每次注射1剂疫苡ї?/span>

                  【不良反应?/span>常见不良反应:接种后24小时内,在注射部位可胢ٽ感到疼痛和触痛,多数情冨下?/span>2~3天内自行消失。罕见不˯反应:?/span>1)⎥种者在接种疫苗?/span>72小时内,可能出现一过性发热反应,一般持?/span>1~2天后可自行缓解。(2)接种部位轻、中度的红肿、疼痛,一般持?/span>1~2天后可自行缓解,不需处理。螁罕见不良反:(1)接种部位可出现硬结,一?/span>1~2个月可自行收。(2)局部无菌性化脓:一般要用注射器反复抽؇脓液,严重时(破溃)需扩创清除坏死组织,病时较ԭ,最吡可吸收愈合。(3)过敏反应:过敏性皮?/span>?/span>阿瑟反应。阿瑟反应一般出玨K在接种?/span>10天左右,局部红肿ûз续时间长,可用固醇类药物进行全身和局部治疗。(4)衺敏性休克:一般在注射疫苗?/span>1 小时内发生,应及时注射肾上腺素等抢救措施进行治疗?/span>

                  【禁  忌?/span>?/span>1)已知对该疫?/span>?/span>的任何樀分,包括辅料、甲醛和酵母过敏耲˵。(2)患急性疾病、严重慢怨疾病、慢性疾病的急性发作期咻е׌发热者。(3)妊娠期妇。(4)对未控制的癫痫和其他进行性神经系统税病者?/span>

                  【注意事项?/span>?/span>1)以下情况һ慎用:家族和个人有惊厥史者、患慢性疾病者、有癫痫史者、过w敏体质者。(2)使用时应充分摇匀,如出现摇不散的凝块、异物、疫苗瓶԰有裂纹或栨签不清者,均不得使用。(3)疫苗瓶开启应立即使用〨(4)应备有肾上腺素等药物,以备偶有发生严重过敏反应时急救用。接受注射者在注射后应在现场观察至?/span>30分钟。(5A注射第1针后出现高热、惊厥等异常情况者,一般不再注射第2针,对于母婴阻断的婴儿,如注射第2?/span>3针应遵医嘱。(6)严禾ƾ冻结?/span>

                  【贮藏?/span>?/span>2?/span>8?/span>避光保ѭ和运输?/span>

                  【包装?/span> 内包杨为西林?/span>?/span>安瓿和预灌封注射?/span>,西林瓶?/span>0.5ml×1?/span>/盒,0.5ml×3?/span>/盒,0.5ml×30?/span>/盒;安瓿?/span>0.5ml×3?/span>/盒,0.5ml×9?/span>/?/span>;预灌封注射器:0.5ml×1?/span>/?/span>?/span>

                  Ҳûϐ有效期?/span>西林瓶:36个月,K瓿:24个月,预灌封注射器:36个月?/span>

                  【执行标准?/span>《中国药典?/span>2015年版三部及药品注册标?/span>WS4-(S-007)-2007Z

                  【批准文号?/span>国药凡字S20040016

                  【生产企业?/span>

                  企业名称?/span>艾美汉信疫苗(大连)有限公司

                  生产地址:大连经济技术开Զշͷ֮区湾达?/span>35?/span>

                  邮政编码?/span>116600  

                  电话号码ӥһ?/span>0411-87549797   87407605

                  传真号码?/span>0411-87549798  

                  ?/span>    址?/span> /



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