藥品名稱
drug name | AVAXIM 80U/0.5mL/SYRI (Hepatitis A Vaccine), 巴斯德A型肝炎疫苗(公費) |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Hepatitis A Vaccine |
| 單位含量 | 80U/0.5mL/SYRI |
| Dosage Forms | Injection, suspension [pediatric/adolescent]: 80 U/0.5 mL [contains aluminum, polysorbate 80, neomycin (may have trace amounts)] |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | 賽諾菲股份有限公司 |
製 造 商
Manufacturer | SANOFI PASTEUR |
字 號
Product ID | 衛部菌疫輸字第000981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 vaccination for:
‧ All children 12 to 23 months of age (CDC/ACIP [Fiore 2006], ACIP [Robinson 2020]).
‧ All unvaccinated children and adolescents 2 through 18 years of age (ACIP [Robinson 2020]).
‧ All unvaccinated adults requesting protection from HAV infection (CDC/ACIP [Fiore 2006]).
‧ Unvaccinated adults with any of the following: Men who have sex with men; injection and non-injection drug users; persons who work with HAV-infected primates or with HAV in a research laboratory setting; persons with HIV; persons with chronic liver disease (eg, persons with hepatitis B or C infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST > twice the upper limit of normal); patients experiencing homelessness; pregnant patients at risk for infection or severe outcome from infection during pregnancy; workers in health care settings targeting services to injection or noninjection drug users or group homes and nonresidential day care facilities for developmentally disabled persons (ACIP [Freedman 2020]; ACIP [Robinson 2020]; CDC/ACIP [Doshani 2019]; CDC/ACIP [Fiore 2006]).
‧ Unvaccinated persons ≧6 months traveling to or working in countries with high or intermediate levels of endemic HAV infection (CDC/ACIP [Nelson 2018]).
‧ 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).
‧ A component of hepatitis A outbreak response, or as postexposure prophylaxis to patients ≧12 months of age within 14 days of exposure, as determined by local public health authorities (CDC/ACIP [Fiore 2006]; CDC/ACIP [Nelson 2018]).
The Canadian National Advisory Committee on Immunization (NACI) also recommends vaccination for the following (NACI 2016):
- Persons ≧6 months at risk for hepatitis A infection (eg, traveling to or from endemic countries) or severe hepatitis A (eg, underlying hepatic disease of idiopathic, metabolic, infectious or cholestatic etiology).
- Infants ≧6 months living with an individual at risk for hepatitis A infection or severe hepatitis A.
- Postexposure prophylaxis:
‧ Healthy patients ≧6 months (vaccine is preferred over immune globulin [Ig]).
‧ Within 14 days of exposure of susceptible adults ≧60 years of age who are household or close contacts of a case (Ig may also be given).
‧ Susceptible individuals with chronic liver disease (Ig should also be administered within 14 days of exposure).
- May be considered in patients who receive repeat administration of plasma-derived clotting factors.
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衛福部核准適用症狀
MOHW approved indications |
可用於12個月至15歲兒童的主動免疫接種，以預防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 |
【Pediatric】
Canadian labeling: Note: Review product labeling carefully; although dose volume is the same, products differ by concentration and appropriate ages; use extra precaution to ensure accuracy.
- Avaxim-Pediatric [Canadian product]: Children and Adolescents ≦15 years: IM: 0.5 mL with a booster dose of 0.5 mL to be administered ideally 6 to 36 months following primary immunization but can be administered up to 7 years following primary vaccination series. Note: The need for an additional booster dose has not been determined; anti-HAV antibodies have been observed up to 14 to 15 years following primary series with Avaxim-Pediatric in healthy subjects.
- Avaxim [Canadian product]: Children ≧12 years and Adolescents: IM: 0.5 mL with a booster dose of 0.5 mL to be administered 6 to 36 months following primary immunization.
【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 |
依文獻內容判定系統稽核懷孕分級建置為：C
UpToDate:
In general, maternal use of inactivated vaccines are not associated with increased risks to the fetus (ACIP [Ezeanolue 2020]). In addition, an increased risk of most adverse maternal or fetal events, including miscarriage or major birth defects, has not been observed following maternal use of the hepatitis A vaccine (Groom 2019; Nasser 2019).
The Centers for Disease Control and Prevention recommends immunization for pregnant patients at risk for hepatitis A infection or patients who are at risk for severe outcomes from infection during pregnancy (ACIP [Freedman 2020]). Refer to current immunization schedule for vaccinating pregnant females.
仿單：
動物試驗並無相關的致畸性資料。
懷孕期間接種A型肝炎疫苗是否會給人類帶來致畸性或胎毒性的風險，至今尚無足夠的資料可供評估。
為預防起見，懷孕期間最好避免接種本疫苗，除非有高度感染的風險。
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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 |
1.對活性成分、任何一種賦形劑、neomycin過敏(可能因製程使用而在劑量中有微量殘留)
2.先前接種此疫苗曾發生過敏
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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 (38℃) [1-5 days postvaccination], >98.6°F (37℃) [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 (38.9℃) (1-5 days postvaccination)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, arthralgia, ataxia (cerebellar), bronchiolitis, bronchoconstriction, croup, dehydration, dermatitis, dizziness, dysgeusia, dyspnea, encephalitis, erythema multiforme, eye irritation, flu-like symptoms, Guillain-Barre syndrome, hematoma at injection site, hepatitis, hyperhidrosis, hypersensitivity reaction, hypertonia, hypoesthesia, increased creatine kinase, increased serum transaminases (transient), injection site reaction (nodule), insomnia, jaundice, lymphadenopathy, multiple sclerosis, myelitis, neuropathy, otitis, paresthesia, photophobia, pneumonia, pruritus, rash at injection site, respiratory congestion, seizure, serum sickness-like reaction, syncope, thrombocytopenia, urticaria, vasculitis, vertigo, viral exanthem, wheezing
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★高警訊藥品
監測建議 |
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監測
Monitoring |
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). 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 |
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。(1100112 仿單資料)
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| 針劑施打條件 |
應以肌肉注射方式接種。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。
(1100112 仿單資料)
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| 針劑保存安定性 |
儲存於冰箱 (2-8℃)且應避免光照。不可冷凍。(1100112 仿單資料)
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最近修改日期時間
Updated | 1/12/2021 9:49:36 AM |
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Available
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Old item
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