英文名:Euvax B
通用名:重组乙型肝炎疫苗(酵母)(Recombinant Hepatitis B Vaccine)
医疗保险:否
产品类别:生物制品
主要成分:每毫升(1.0mL)Euvax B注射液含有20µg纯HBsAg(乙肝表面抗原)
适应症: 预防乙肝病毒感染引起的乙型肝炎
【使用方法】
1. 仅在肌肉注射使用。
2. 一份小儿用量为0.5毫升,含有10µg纯HBsAg(乙肝表面抗原)(包括新生儿、婴幼儿和年龄至15岁含15岁的儿童)。
3. 一份成人用量为1.0毫升,含有20µg纯HBsAg(乙肝表面抗原)(年龄在16岁以上)。
4. 推荐免疫程序可遵照以下时间表,免疫程序共包括3次疫苗注射
第一次:择选日期
第二次:第一次注射后的一个月
第三次:第一次注射后的六个月
5. 另一种推荐免疫程序可选择0月、1月和2月进行疫苗注射。在12个月时需要加强免疫一针。加强针是针对特定人群(例如新生儿来自受乙肝感染的患者,某些受到或可能近期暴露于存在乙肝病毒环境,或存在乙肝患者的高危区域)。
6. 当首次免疫过程结束后保护抗体效价未达到预定水平时,血液透析或免疫缺陷的患者则需要再进行额外疫苗的注射。
【规 格】
10µg/0.5ml/vial×1, 20 vials/pack
20µg/1.0ml/vial×1, 20 vials/pack
100µg/5.0ml/vial×10, vials/pack
200µg/10.0ml/vial×10, vials/pack
【贮 藏】
低温2°C- 8°C储存(冰箱内)请勿冷冻
【有 效 期】
36个月
【生产企业】
企业名称:LG Life Sciences, Ltd.
Product Name
Euvax B
Composition
Each ㎖ of Euvax B Inj. contains 20㎍ of purified HBsAg.
Indication
Immunization against infection caused by all known subtypes of hepatitis B virus
Dosage and Administration
- Intramuscular use only
- One pediatric dose (neonates, infants, and children aged up to and including 15 years of age) is 0.5㎖ containing 10㎍ of HBsAg
- One adult dose (from 16 years) is 1.0㎖ containing 20㎍ of HBsAg
- The immunization regimen consists of three doses of vaccine given according to the following schedule;
1st dose : at elected date
2nd dose : 1 month after the first dose
3rd dose : 6 months after the first dose
- An alternative 0, 1 and 2 months schedule and a 12 months booster can be used in certain populations (e.g. neonates born from Hepatitis B-infected others, someone who has or might have been recently exposed to the virus, certain travelers to high-risk areas)
- Additional dose(s) of vaccine may be required in hemodialysis or immunodeficient patients since protective anti-body titers (>10IU/I) may not be obtained after the primary immunization course
How Supplied
10㎍/0.5㎖/vial×1, 20 vials/pack
20㎍/1.0㎖/vial×1, 20 vials/pack
100㎍/5.0㎖/vial×10 vials/pack
200㎍/10.0㎖/vial×10 vials/pack
Storage Condition
Store between 2℃ and 8℃ (in a refrigerator). Do not freeze.
Shelf Life
36 months