藥品名稱
drug name | Hepatitis A Vaccine (Havrix, 新赫寶克) 720 Elisa Units/0.5 mL/PFS |
| 藥檔狀態 | 停用 （需冷藏） |
成 份
Ingredient | Hepatitis A Vaccine |
| 單位含量 | 720 Elisa Units/0.5 mL/PFS |
| Dosage Forms | Injection: 720 ELISA units / 0.5 mL /PFS |
| 外觀描述 | 針劑/肌肉注射 |
| Appearance | injection/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 reactions | Injection 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。
2.25℃下放置3天是穩定的低。(仿單資料)
3.藥品容器由「vial」變更為「pre-filled syringe」。 (1081028公告)
|
最近修改日期時間
Updated | 7/25/2022 4:07:54 PM |