藥品名稱
drug name | 自費 Hepatitis A Vaccine, Inactivated (VAQTA Inj.) 25 U/0.5 mL/vial 唯德不活化A型肝炎疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Hepatitis A Virus Vaccine, Inactivated |
| 單位含量 | 25U/0.5ml/vial |
| Dosage Forms | Injection: 25U /0.5 ml (0.5 ml) |
| 顏 色 | |
| Color | |
| 形 狀 | 紫色蓋 |
| Shape | |
| 劑 型 | 針劑/注射 |
| Dose Form | |
大 小
Size | |
標 示
outward | |
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 | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated) |
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 | A肝疫苗 |
| Use |
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])
|
衛福部核准適用症狀
MOHW approved indications |
預防Ａ型肝炎。
|
| 常用劑量 | 每天一次，早飯後使用1vial
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
IM in the deltoid region only.
Dosing Regiments for Hepatitis A Vaccine:
VaqtaR ≧ 19 y/o:
Primary immunization, 50 U (1 mL);
booster dose: 50 U (1 mL) to be given 6-18 months after primary immunization
VaqtaR 12 m/o-18 y/o:
Primary immunization,25 U (0.5 mL);
booster dose: 25 U (0.5 mL) to be given 6-18 months after primary immunization
|
懷孕分級
Pregnancy Risk Factor |
C
-
[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。]
|
| 禁忌症 |
如對疫苗中的任何一成份過敏者。
|
| Contraindications |
mmediate 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 | 疲倦，頭痛，咽喉炎，注射部位不適。 |
| Common adverse drug reactions | Fatigue, headache, pharyngitis, discomfort in the injection site. |
| Adverse Reactions |
Irritability, drowsiness, headache, fever, anorexia; injection site pain, soreness, tenderness, erythema, warmth, swelling, bruising; rash, menstrual disorder, diarrhea, vomiting, nausea, abdominal pain, anorexia, weakness/fatigue, myalgia, arm pain, back pain, stiffness, conjunctivitis, otitis media, otitis, upper respiratory tract infection, rhinorrhea, cough, pharnyngitis, respiratory congestion, nasal congestion, laryngotracheobronchitis, crying, viral exanthema
|
監測
Monitoring |
Liver function tests; monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
|
| 警語與注意事項 | 冷藏保存；不可口服。 |
| Warnings & precautions | should be refrigerated between 2-8 ℃. |
| 針劑溶解條件 |
|
| 針劑稀釋條件 |
|
| 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。
|
| 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。
|
| 針劑保存安定性 |
須存放於2-8℃。
|
最近修改日期時間
Updated | 1/12/2018 7:52:28 PM |