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                  ?/span>药品名称?/span>

                  通用名称:重组乙型肝炎疫苗(汉逊酵毡)

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

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

                  【成ⲻɥʬ˭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原?/span>HBsAg)经纯化,加入铝佐剂后制ȫ成。为乳白艡混悬液体,可因沉淀而分层,易摇散。有效成分:乙型Ů񹴴炎病毒表面抗原?/span>辅料:氢氧化铝、氯化钠?/span>

                  【接秼ʸɽк对象?/span>本疫苗适用于乙ơ型肝炎易感者,尤其下列人员:(1)新ǺһЦ儿,特别是母亲?/span>HBsAg?/span>HBeAg阳性者。(2常ҰһŻ‰从事医疗工作的医护人员Լǰ첲ָ첲及接触血液Ϊ实验人员?/span>

                  【作用与用途?/span>接种本疫苗后,可刺激机体产生抗乙型肝炎病毒的免粻ھż力。用于预防乙型肝炎?/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һͨͨ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,新生᰷Ҷ儿在出生?/span>24小时内注射第1针,每次注射1剂ʱ苗?/span>

                  【不良反应?/span>常见不良应:接种后24小时内,在注射部位可能感到疼痛和触痛,多数情况下亵DZԼȳ?/span>2~3天内自行消失。罕见不良反应:ͻȻееʧ?/span>1)接种Ǵ˴ǰ在接种疫苗?/span>72小时内,可能出现一过性发热反应Qټ一般持?/span>1~2天后可自行췢켓解。(2)接种部位轻、中度的红肿、疼Ŀ⽥痛,一般持?/span>1~2天后可自行Գ͢解,不需处理。极罕见不ٷ֮ى反应:(1)接种部位可出现硬结,一?/span>1~2个月可自行吸。(2)局部无菌性化脴ɵʮһ:一般要用注射器反复抽出脓液,严重时(破溃)需扩创清除坏死组织,病时较长,最后可吸收ɽ愈合。(3)过敏反应:迼ƻ敏性皮?/span>?/span>阿瑟反应。阿瑟反应一般出现在接种?/span>10天左右һͻȻغϼ局部红肿持续时һ间长,可用固醇类药物进行全身和蹺ݯ˱部治疗。(4)过敏性休克: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>的任何成分,匸Dž括辅料、甲醛和酽Ҳвѵ母过敏者。(2)患急性疾病、严重ȻŻ˅性疾病、慢性疾病的急性发作期和发热者。(3)妊娠汾œ妇女。(4)对未控Ȼﲻ的癫痫和Ӆ他进行性神经系统疾病者?/span>

                  【注意事项ҡҡͷдϲ?/span>?/span>1)以下情冡者慎用:家族和个人有惊厥叻Ȼì˲者、患慢性疾病者、有癫痫史者、过敏体ͷ˿Ш者。(2)使用时应充分摇匀,如出现摇不散的凝块dz异物、疫苗瓶有裂纹或标签不清者,坺不得使用。(3)疫苗瓶开启应立即使用。(4)应夳֮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Լ¥者在注射后应在现场观察至?/span>30分钟。(5)注射第1针后出现高热、惊厥等异常情况者,一般不再˳射第2针,对于母婴阻断的婴儿,如注射第2?/span>3针应選ʱҲѵ医嘱。(6)严禁冻结?/span>

                  񲻻˵贮藏?/span>?/span>2?/span>8?/span>避光保存和运输?/span>

                  【包装?/span> 内包材为西林?/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>

                  【有效期?/span>西林瓶:36个月,安瓶ҿ: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Ƿȱ册标?/span>WS4-(S-007)-2007Z

                  【批准文号?/span>国药准字S20040016

                  【生产企业?/span>

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

                  生产地址:大连չЦ济技术开发ѹɌ湾达跡?/span>35?/span>

                  邮政编码pry5853?/span>116600  

                  电话号码?/span>0411-87549797   87407605

                  传真号码?/span>0411-87549798  

                  ?/span>    址?/span> /



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