藥品名稱
drug name | 公費 Hepatitis A Vaccine (Havrix/ Vaqta(舊名), 新赫寶克A型肝炎疫苗(兒童用)) 720 Elisa Units/0.5 mL/syringe |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Hepatitis A Virus, Purified, Inactivated |
| 單位含量 | 720 Elisa Units/0.5 mL/syringe |
| Dosage Forms | Injection: 720 Elisa Units/0.5 mL/syringe |
| 外觀描述 | 針劑/針筒 |
| Appearance | injection/IM |
標 示
outward | 肌肉注射 |
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 | Hepatitis A vaccine offers active immunization against hepatitis A virus infection at an effective immune response rate in up to 99% of subjects |
| 用途/適應症 | A型肝炎疫苗 |
| Use |
Prophylaxis of hepatitis A virus infection
|
衛福部核准適用症狀
MOHW approved indications |
Ａ型肝炎之主動免疫。
|
| Dose |
Administration: IM
Dosing Regiments for Hepatitis A Vaccine:
12 m/o-18 y/o: 720 EL.U. (0.5 mL) once followed by a booster dose 6-12 months later.
|
懷孕分級
Pregnancy Risk Factor |
C
|
| 禁忌症 |
對本產品任何成份有過敏反應者禁用。
先前曾對A型肝炎疫苗或任一疫苗成份產生嚴重反應者不可使用。
|
| Contraindications |
Immediate and/or severe allergic or hypersensitivity reaction to hepatitis A containing vaccines or any component of the formulation, including neomycin.
|
| 常見副作用 | 發燒、注射部位之疼痛、紅腫等。 |
| Common adverse drug reactions | Fever, pain at the injection site, redness and swelling. |
| 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°F [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 (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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| 警語與注意事項 | 民國106年1月1日(含)以後出生，年滿12個月以上之幼兒。 1080718換Avaxim。 |
| Warnings & precautions | 民國106年1月1日(含)以後出生，年滿12個月以上之幼兒。 原公費A肝疫苗實施地區不限106年出生之幼兒。 |
| 針劑溶解條件 |
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| 針劑稀釋條件 |
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| 針劑不相容性 |
因缺乏相容性研究，本品不應與其他藥物混合使用。不可與其他疫苗在同一支注射器內混合注射。(1080718仿單資料)
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| 針劑施打條件 |
採肌肉注射方式。建議接種部位為三角肌。
在特殊情況下，本疫苗可以皮下注射方式注射於患有血小板減少症或有出血風險的患者。
本疫苗不可接種於臀部，因為這個部位的脂肪組織量因人而異，可能導致疫苗療效之差異。
不可以靜脈注射方式接種；確認針頭不可刺入血管。
不可以皮內注射方式接種。(1080718仿單資料)
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| 針劑保存安定性 |
須存放於2-8℃且應避免光照。不可冷凍。。
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最近修改日期時間
Updated | 5/2/2022 3:11:53 PM |