藥品名稱
drug name
公費 Japanese Encephalitis Virus Vaccine (Imojev Injection, 巴斯德細胞型日本腦炎活性減毒疫苗) 0.5 mL/ 1 dose/ vial
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Live Attenuated, Japanese Encephalitis Virus Vaccine
單位含量0.5 mL/ 1 dose/ vial
Dosage FormsSolution, Injection:0.5 mL/ 1 dose/ vial
外觀描述 針劑/小瓶
Appearanceinjection/vial
標  示
outward
廠商名稱
Manufacturer
賽諾菲股份有限公司
製 造 商
Manufacturer
GPO-MBP, THAILAND
字  號
Product ID
衛部菌液輸字第000967號
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (live attenuated)
作用機轉
Mechanism of action
Imojev is a monovalent, live-attenuated viral vaccine.The virus replicates locally and elicits neutralising antibodies and cell-mediated immune responses that are specific to the Japanese encephalitis virus. Available results indicate that protection is mainly mediated by neutralising antibodies.
用途/適應症日本腦炎疫苗。
Use 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12個月。
衛福部核准適用症狀
MOHW approved indications
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。
Dose Administration Route: SC
Prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus:
Primary Vaccination: Adult ≧18 yrs & Children ≧12months:0.5 mL single dose.

Booster dose:
1. Children should received booster dose 0.5mL after 12~24months of the first dose.
2. Imojev can be given as a booster vaccination in children who were previously given an inactivated Japanese encephalitis vaccine for primary vaccination.

依我國ACIP建議:
(接種次數2次,劑量:1支(0.5mL)/dose))
於出生滿15個月接種第1劑,隔27週後接種第2劑(與第1劑間隔12個月)。
懷孕分級
Pregnancy Risk Factor
仿單: 懷孕期間禁止接種,接種疫苗後4週內應避免懷孕。
禁忌症 1.有發燒者,或有顯著營養障礙者。
2.罹患心臟血管系統疾病、腎臟疾病、肝臟疾病、糖尿病或腳氣病者,當該疾病在急性期或增惡期及活動期中者。
3.為本劑之成分所引起過敏之虞者。
4.接種本劑後,曾有呈顯著異常之副作用反應者。
5.在接種前一年以內,曾發生痙攣者。
6.孕婦。
7.除上所記載外,不適宜預防接種狀態者。
8.對thimerosal過敏者。
Contraindications 1. History of severe allergic reaction to any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components or constituents.
2. Case of febrile or acute disease.
3. Congenital or acquired immune deficiency impairing cellular immunity, including immunosuppressive therapies such as chemotherapy, high doses of systemic corticosteroids given generally for 14 days or more.
4. Symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.
5. Pregnant and breastfeeding women.
常見副作用注射部位紅腫、疼痛;頭痛、肌肉痛、腹痛。
Common adverse drug reactionsInjection site inflamed, pain;headache, muscle pain, abdominal pain。
Adverse Reactions More frequent: fever, fatigue, malaise, injection site pain / tenderness/ redness, headache, myalgia, vomiting, drowsiness, loss of appetite, irritability, abnormal crying

Less frequent: feeling hot, hcills, injection site reaction, dizziness, arthralgia, diarrhea, nausea, abdominal pain, pharyngolaryngealpain, dyspnea, rhinorrhoea, cough, wheezing, nasal congestion

Rare: injection site reactions (induration, pruritus, bruising, haematoma, bleeding), upper respiratory tract infection, viral infections, rash, maculopapular rash, urticaria, changes in the colour of the skin after inflammatory reaction
監測
Monitoring
Observe patients for 30 minutes after vaccination for anaphylactic/hypersensitivity reactions and syncope
警語與注意事項限公費病人使;不可口服
Warnings & precautions 
針劑溶解條件
針劑稀釋條件
針劑不相容性
針劑施打條件 1.當其他疫苗與Imojev同時接種時,應注射於不同部位並使用不同的注射器。
2.針對12個月以上兒童,Imojev可與麻疹、腮腺炎或德國麻疹疫苗(個別疫苗或混合疫苗)同時接種。
3.成人可以同時接種Imojev與黃熱病疫苗。
針劑保存安定性 未開封:2-8℃冷暗儲存,凍結過的疫苗請勿使用。
最近修改日期時間
Updated
5/23/2017 3:59:46 PM
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