藥品名稱
drug name
Japanese Encephalitis Vaccine 0.5 ml/vial "IMOJEV" (公費)日本腦炎疫苗
藥檔狀態使用中
成  份
Ingredient
Japanese Encephalitis Virus Vaccine
單位含量0.5 ml/vial
Dosage FormsSuspension Reconstituted, SubQ: 0.5mL
外觀描述 
Appearance 
廠商名稱
Manufacturer
賽諾菲股份有限公司
製 造 商
Manufacturer
Merieux Biological Products Co., Ltd
字  號
Product ID
衛部菌疫輸字第000967號
藥理分類
Pharmacologic Category
Vaccine, Live (Viral)
作用機轉
Mechanism of action
This vaccine contains live attenuated viruses which replicate locally and induce antibodies (main protective effect) and cell-mediated immune responses to neutralize the Japanese encephalitis virus. Antibody response is measured using a 50% plaque-reduction neutralization antibody test (PRNT50); a threshold of ≧1:10 is considered protective immunity (Nasveld 2010).
用途/適應症 
Use Note: Not approved in US and/or Canada

Japanese encephalitis vaccination: For active immunization against Japanese encephalitis (JE) virus. Note: Per WHO, the minimum recommended age of administration is 8 months for live attenuated SA 14-14-2 vaccine (CD.JEVAX) and 9 months for live attenuated chimeric vaccine (Imojev) (WHO 2015).
衛福部核准適用症狀
MOHW approved indications
Imojev 可用於預防日本腦炎病毒所引起的日本腦炎,接種者的年齡應等於或大於9個月。
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】
Primary immunization: SubQ:
Imojev: 0.5 mL as a single dose. Note: booster dose is not needed for up to 5 years in adults (immunogenicity data beyond 5 years are not available after a single dose).

【Pediatric】
Primary immunization: Infants, Children, and Adolescents: SubQ: Note: Specific age recommendations may vary per country/region; refer to local product labeling and vaccine schedules for additional details.
- Imojev: Minimum recommended age of administration is 9 months (WHO 2015): 0.5 mL as a single dose

Booster immunization: Children and Adolescents: SubQ: Note: Necessity and timing of booster doses may vary per country/region. The need for a booster dose in endemic regions has not been clearly established (WHO 2015); refer to local product labeling and vaccine schedules for additional details.
- Imojev:
>> Following primary vaccination with live/attenuated JE vaccine: 0.5 mL as a single dose given 12 months (preferable) to 24 months after primary vaccination.
>> Following primary vaccination with inactivated JE vaccine: 0.5 mL as a single dose given at the recommended timing for the next scheduled booster of the inactivated JE vaccine.

依我國衛服部疾病管製署建議
幼兒常規接種時程:應接種2劑
於出生滿15個月接種第1劑,間隔12個月接種第2劑。

已接種不活化日本腦炎疫苗之幼童,依下列原則接續完成
已接種1劑:與前一劑間隔14天以上接種第1劑,間隔12個月接種第2劑。
已接種2劑:與最後一劑間隔至少12個月後接種1劑,其後不必再追加。
已接種3劑:滿5歲至入學前接種1劑,與最後一劑間隔至少12個月。

【Geriatric】
Refer to adult dosing.

【Renal Impairment】
No dosage adjustment provided in manufacturer’s labeling.

【Hepatic Impairment】
No dosage adjustment provided in manufacturer’s labeling.
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:X

UpToDate:
Use of the live/attenuated vaccine is contraindicated in pregnant women. Imojev product labeling also recommends women of childbearing age should be advised not to become pregnant for 4 weeks after vaccination. Infection from Japanese encephalitis during the first or second trimesters of pregnancy may increase risk of miscarriage. Intrauterine transmission of the Japanese encephalitis virus has been reported (CDC [Fischer 2010]). According to WHO, pregnant women at high risk of contracting Japanese encephalitis virus may be vaccinated; however, inactive vaccines are preferred where available. Pregnancy testing is not a prerequisite for administration of any Japanese encephalitis vaccine. Inadvertent administration of a live/attenuated Japanese encephalitis vaccine is not an indication for termination of pregnancy (WHO 2015).

仿單:
動物試驗並無直接或間接證據顯示對懷孕、胚胎發展、分娩、產後胎兒發展具傷害性。
如同所有的活性減毒疫苗一樣,懷孕婦女禁止接種。(懷孕為仿單禁忌症)
-----------------------------------------------------------
[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 1.對疫苗之任何成分層有嚴重過敏反應,或之前接種本疫苗或接種與本疫苗含有相同成分或組成的疫苗後曾出現嚴重過敏反應者或有嚴重過敏病史,不應接種Imojev。
2.先天或後天免疫缺損而致細胞性免疫不全者,包括接受免疫抑制治療(例如化學治療、14天或以上的高劑量全身性皮質類固醇)。
3.感染人類免疫缺陷病毒的患者,不論其已出現症狀,或未出現症狀但有免疫功能缺損之證據者,皆不可接種IMOJEV。
4.懷孕。
5.授乳。
Contraindications Previous severe allergic reaction to any component of the vaccine or any vaccine with the same constituents; acute febrile illness; immune deficiency (congenital or acquired, including concomitant immunosuppressive therapies such as chemotherapy or high-dose systemic corticosteroid use for≧14 days); patients with HIV (symptomatic, or asymptomatic with evidence of impaired immunity); pregnancy; breast-feeding; intravenous administration
常見副作用 
Common adverse drug reactions 
Adverse Reactions >10%:
Central nervous system: Malaise (children: 33%; adults: 17%), irritability (children: 27%), excessive crying (children: 20%), headache (children: 21%), drowsiness (children: 19%)
Gastrointestinal: Anorexia (children: 25%), vomiting (children:≦17%)
Local: Pain at injection site (children:≦22%; adults: 12%), tenderness at injection site (children:≦22%), erythema at injection site (children: 20%; adults: 4%)
Neuromuscular & skeletal: Myalgia (children: 24%; adults: 15%)
Miscellaneous: Fever (children: 20%)

1% to 10%:
Central nervous system: Feeling hot (adults: 8%), chills (adults: 6%), dizziness (adults: 1%)
Dermatologic: Injection site pruritus (adults: 4%; children: <1%)
Gastrointestinal: Diarrhea (adults: 8%), nausea (adults: 7%)
Local: Swelling at injection site (children: 6%; adults: 1%)
Neuromuscular & skeletal: Arthralgia (adults: 7%)
Respiratory: Dyspnea (adults: 3%), pharyngolaryngeal pain (adults: 3%)

<1%, postmarketing, and/or case reports: Asthma, bleeding at injection site, bronchitis, bruising at injection site, cellulitis, cough, dyschromia, enteritis, excoriation of skin, hematoma at injection site, increased bronchial secretions, induration at injection site, infection of mouth (herpangina), maculopapular rash, miliaria, otitis media, pharyngitis, pneumonia, pruritus, rhinitis, sinusitis, skin rash, sore throat, stomatitis, tonsillitis, upper respiratory tract infection, urticaria, varicella zoster infection, viral infection
★高警訊藥品
監測建議

監測
Monitoring
Observe for anaphylaxis/hypersensitivity reaction for 30 minutes following administration.
警語與注意事項 
Warnings & precautions 
針劑溶解條件 使用無菌技術,利用包裝盒內附的注射器及其中一支針頭,將0.4%氯化鈉溶液全部抽出,然後注入含有凍晶疫苗的玻璃小瓶,以配製IMOJEV疫苗。輕輕旋轉玻璃小瓶。當凍晶粉末完全溶解後,使用同一支注射器抽出0.5毫升劑量的重組懸浮液。接著,將注射器換上包裝盒內附的第2支針頭,然後再進行注射。
本品一旦配製後,應立即使用。(1100518仿單資料)
針劑稀釋條件
針劑不相容性 因為未曾做過相容性試驗,因此本疫苗不可與任何其他疫苗或藥物混合使用。(1100518仿單資料)
針劑施打條件 應以皮下注射方式接種。
若接種者的年齡≧2歲,建議之注射部位為上臂。
若接種者的年齡介於9-24個月,則建議之注射部位為大腿的前外側。
不可以靜脈注射方式接種。(1100518仿單資料)
針劑保存安定性 儲存於冰箱(2℃-8℃),不可冷凍,玻璃小瓶應放置盒內以避免光照。
本品一旦配製後,應立即使用。(1100518仿單資料)
最近修改日期時間
Updated
5/19/2021 2:37:16 PM
台北新店
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