藥品名稱
drug name | 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 Forms | Solution, Injection:0.5 mL/ 1 dose/ vial |
| 外觀描述 | 無色至琥珀色之懸浮液針劑/皮下注射 |
| Appearance | injection |
標 示
outward | |
廠商名稱
Manufacturer | 裕利股份有限公司 |
製 造 商
Manufacturer | Global Biotech Products Co., Ltd., 泰國 |
字 號
Product ID | 衛部菌疫輸字第000967號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Live) |
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 |
For prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over. JE vaccination is appropriate for travelers visiting endemic areas during periods of JE transmission.
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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。
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| 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.
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懷孕分級
Pregnancy Risk Factor |
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.
仿單: 懷孕期間禁止接種，接種疫苗後4週內應避免懷孕。
Lactation: contraindicated in women who are breast-feeding.
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| 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。
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| 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.
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| 常見副作用 | 注射部位紅腫、疼痛；頭痛、肌肉痛、腹痛。 |
| Common adverse drug reactions | Injection 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
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監測
Monitoring |
Observe patients for 30 minutes after vaccination for anaphylactic/hypersensitivity reactions and syncope
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| 警語與注意事項 | 請遵照醫師或藥師指示使用；不可口服 |
| 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 |
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| 針劑施打條件 |
1.皮下注射方式接種
2..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。
3.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。
4.成人可以同時接種Imojev與黃熱病疫苗。
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| 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。
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最近修改日期時間
Updated | 10/13/2023 2:01:07 PM |