藥品名稱
drug name
Hepatitis A Vaccine (Havrix, 新赫寶克) 720 Elisa Units/0.5 mL/vial
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Hepatitis A Vaccine
單位含量720 Elisa Units/0.5 mL/vial
Dosage FormsInjection: 720 ELISA units / 0.5 mL /vial
外觀描述 針劑/肌肉注射
Appearanceinjection/IM
標  示
outward
pre-filled syringe
廠商名稱
Manufacturer
荷商葛蘭素史克藥廠股份有限公司臺灣分公司
製 造 商
Manufacturer
GLAXOSMITHKLINE BIOLOGICALS S.A.,BELGIUM
字  號
Product ID
衛署菌疫輸字第000456號
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated)
作用機轉
Mechanism of action
Passive prophylactic immunity to hepatitis B following acute exposure to blood containing hepatitis B surface antigen (HBsAg)
用途/適應症A型肝炎疫苗
Use Active immunization against disease caused by hepatitis A virus in populations desiring protection against or at high risk of exposure.
衛福部核准適用症狀
MOHW approved indications
A型肝炎之主動免疫。
Dose Adults:
1440 ELISA units (1 mL, 2 vial)with a booster dose of 1440 ELISA units to be given 6-12 months following primary immunization

Pediatrics:
1-18 years: 720 ELISA units (0.5 mL, 1 vial) with a booster dose of 720 ELISA units to be given 6-12 months following primary immunization
懷孕分級
Pregnancy Risk Factor
C
Lactation: Excretion in breast milk unknown/use caution
禁忌症 如對疫苗中的任何一成份過敏者或第一次注射Havrix後產生過敏現象的人均不可使用。
Contraindications persensitivity to yeast, hepatitis B vaccine, or any component of the formulation
常見副作用注射部位紅腫、疼痛;頭痛、嘔吐、發燒。
Common adverse drug reactionsInjection site inflamed, pain;headache, vomiting, fever.
Adverse Reactions Frequency dependent upon age, product used, and concomitant vaccine administration. In general, headache and injection site reactions were less common in younger children.
>10%:
Central nervous system: Drowsiness, headache, irritability
Gastrointestinal: Decreased appetite
Local: Erythema at injection site, injection site reaction (soreness, warmth), pain at injection site, swelling at injection site, tenderness at injection site
Neuromuscular & skeletal: Weakness
Miscellaneous: Fever (≧100.4°F [1-5 days postvaccination], >98.6°C [1-14 days postvaccination])

1% to 10%:
Central nervous system: Chills, fatigue, insomnia, malaise
Dermatologic: Skin rash
Endocrine & metabolic: Menstrual disease
Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, gastroenteritis, nausea, vomiting
Local: Bruising at injection site, induration at injection site
Neuromuscular & skeletal: Arm pain, back pain, myalgia, stiffness
Ophthalmic: Conjunctivitis
Otic: Otitis media
Respiratory: Asthma, cough, nasal congestion, nasopharyngitis, pharyngitis, rhinitis, rhinorrhea, upper respiratory tract infection
Miscellaneous: Excessive crying, fever≧102°F (1-5 days postvaccination)
監測
Monitoring
Liver function tests; monitor for syncope for 15 minutes following administration.
警語與注意事項注射用藥。
Warnings & precautions 
針劑溶解條件 不需溶解。(1070905仿單資料)
針劑稀釋條件 不需稀釋。(1070905仿單資料)
針劑不相容性 不可與其他疫苗混合於同一注射器內。(1070905仿單資料)
針劑施打條件 1.應以肌肉注射方式注射於成人或兒童的手臂三角肌部位,嬰兒則應注射於大腿前外側。不可採臀部注射或皮內注射方式投予,因為這種投予方式所產生的免疫反應較低。(1070905仿單資料)
2.血小板不足患者或異常流血症患者採肌肉注射時須要小心,必須在注射部位加壓至少兩分鐘(不可搓揉)。
針劑保存安定性 1.未開封:2-8℃冷藏儲存。不可冷凍。
37℃下放置3星期,效價沒有顯著降低。(1070905仿單資料)
2.藥品容器由「vial」變更為「pre-filled syringe」。 (1081028公告)
最近修改日期時間
Updated
10/28/2019 3:04:40 PM
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