藥品名稱
drug name | Hepatitis A Vaccine, Inactivated 50U/mL/vial (VAQTA), 唯德不活化A型肝炎疫苗 |
| 藥檔狀態 | 停用 |
成 份
Ingredient | Hepatitis A Vaccine, Inactivated |
| 單位含量 | 50U/mL/vial |
| Dosage Forms | Injection, suspension:Hepatitis A virus antigen 50 units/mL (1 mL) |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | 美商默沙東藥廠股份有限公司台灣分公司 |
製 造 商
Manufacturer | MERCK SHARP & DOHME CORP. |
字 號
Product ID | 衛署菌疫輸字第000501號 |
藥理分類
Pharmacologic Category | Vaccine; Vaccine, Inactivated (Viral) |
作用機轉
Mechanism of action | As an inactivated virus vaccine, hepatitis A vaccine induces active immunity against hepatitis A virus infection. |
| 用途/適應症 | |
| Use |
Hepatitis A virus disease prevention:
For active immunization of persons 12 months and older against disease caused by hepatitis A virus (HAV).
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for:
- All children≧12 months of age (CDC/ACIP [Fiore 2006])
- All unvaccinated adults requesting protection from HAV infection (CDC/ACIP [Fiore 2006])
- Unvaccinated persons with any of the following conditions: Men who have sex with men; injection and non-injection illicit drug users; persons who work with HAV-infected primates or with HAV in a research laboratory setting; persons with chronic liver disease; patients who receive clotting-factor concentrates; persons traveling to or working in countries with high or intermediate levels of endemic HAV infection (CDC/ACIP [Fiore 2006])
- Unvaccinated persons who anticipate close personal contact with international adoptee from a country of intermediate to high endemicity of HAV, during their first 60 days of arrival into the United States (eg, household contacts, babysitters) (CDC/ACIP 58[36] 2009)
- Vaccination can be a component of hepatitis A outbreak response or as postexposure prophylaxis, as determined by local public health authorities (CDC/ACIP 56[41] 2007; CDC/ACIP [Fiore 2006])
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衛福部核准適用症狀
MOHW approved indications |
預防Ａ型肝炎。
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| 常用劑量 |
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
Adult
Immunization: Note: Although it is preferred to use the vaccines according to their approved labeling, Havrix and VAQTA are considered to be interchangeable for booster doses (CDC/ACIP [Fiore 2006]).
Primary immunization: Note:?When used for primary immunization, the vaccine should be given at least 2 weeks prior to expected HAV exposure. When used prior to an international adoption, the vaccination series should begin when adoption is being planned, but ideally ≧2 weeks prior to expected arrival of adoptee (CDC 58[36] 2009).
IM: 50 units (1 mL) with a booster dose of 50 units (1 mL) to be given 6-18 months after primary immunization (6 to 12 months if initial dose was with Havrix).?Note:?Canadian labeling recommends that adults with HIV receive a booster dose 6 months after primary immunization.
Pediatric
Immunization:?Note:?Although it is preferred to use the vaccines according to their approved labeling, Havrix and VAQTA are considered to be interchangeable for booster doses (CDC/ACIP [Fiore 2006]).
Primary immunization:?Advisory Committee on Immunization Practices (ACIP): Children ?12 months: All children should receive primary immunization with a two-dose series. The series should be initiated at 12 to 23 months; the two doses should be separated by 6 to 18 months (CDC/ACIP [Fiore 2006]).?Note:?When used for primary immunization, the vaccine should be given at least 2 weeks prior to expected HAV exposure. When used prior to an international adoption, the vaccination series should begin when adoption is being planned, but ideally ≧2 weeks prior to expected arrival of adoptee (CDC 58[36] 2009).
Children ≧12 months and Adolescents: IM: 25 units (0.5 mL) with a booster dose of 25 units (0.5 mL) to be given 6 to 18 months after primary immunization (6 to 12 months if initial dose was with HAVRIX)
Geriatric:
Refer to adult dosing.
Renal Impairment:
There are no dosage adjustments provided in the manufacturer’s labeling.
Hepatic Impairment
There are no specific recommendations provided in manufacturer’s labeling. However, data suggest patients with chronic liver disease have a lower antibody response to HAVRIX than healthy subjects.
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懷孕分級
Pregnancy Risk Factor |
C
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[FDA(美國食品及藥物管理局)懷孕分級說明:
A：對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B：動物試驗無法證實對胎兒有害，但缺乏人類對照試驗；或動物試驗有副作用報告，但無法證實對懷孕初期及後期之胎兒有害。
C：動物實驗中對胎兒有害但缺乏孕婦對照實驗；或無動物及孕婦試驗。
D：證實對胎兒有害，但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X：證實對胎兒有害，且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
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| 禁忌症 |
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| Contraindications |
Immediate and/or severe allergic or hypersensitivity reaction to hepatitis A containing vaccines or any component of the formulation, including neomycin.
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| 常見副作用 | |
| Common adverse drug reactions | |
| 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)
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★高警訊藥品
監測建議 |
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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 | |
| Warnings & precautions | |
| 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 |
如必須與其他疫苗或免疫球蛋白併用，應以不同注射針筒及針頭在不同注射部位施打。(1051027仿單資料)
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| 針劑施打條件 |
採肌肉注射方式，並應注射於成人或孩童的三角肌部位，嬰兒則應注射於大腿前外側部位。不可血管內、皮內或皮下注射。(1051027仿單資料)
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| 針劑保存安定性 |
須存放於2-8℃。(1051027仿單資料)
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最近修改日期時間
Updated | 1/7/2020 4:42:14 PM |
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現用藥品
Available
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停用藥品
Old item
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藥品仿單
DrugLabeling
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