藥品名稱
drug name | Ixiaro 0.5mL/vial (Japanese encephalitis vaccine)日本腦炎疫苗(不活化型) |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Japanese encephalitis vaccine |
| 單位含量 | 0.5mL/syringe |
| Dosage Forms | Suspension, Intramuscular :0.5mL |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | Valneva Austria GmbH |
製 造 商
Manufacturer | Valneva Scotland Ltd. |
字 號
Product ID | 衛署藥製字第000000號 |
藥理分類
Pharmacologic Category | Vaccine;Vaccine, Inactivated (Viral) |
作用機轉
Mechanism of action | This vaccine induces antibodies 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. |
| 用途/適應症 | |
| Use |
Japanese encephalitis prevention:Active immunization against Japanese encephalitis (JE) for persons 2 months of age and older
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衛福部核准適用症狀
MOHW approved indications |
疾管署專案進口用於不適用活性疫苗之幼兒施打。
仿單：預防日本腦炎。適用於2個月以上嬰幼兒及成人。
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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 |
Dosing: Adult
此藥非提供給成人使用
Primary immunization:IM: 0.5 mL/dose; a total of 2 doses given on days 0 and 28. Series should be completed at least 1 week prior to potential exposure.
Booster dose:Booster dose may be given prior to potential re-exposure if the primary series was completed >1 year previously.
Note:If the second dose is missed, limited data from one clinical trial in adults demonstrate a 99% seroconversion rate when the second dose was administered 11 months after the initial dose.
Dosing: Pediatric
Primary immunization:
Infants and Children 2 months to <3 years: IM: 0.25 mL/dose; a total of 2 doses given on days 0 and 28. Series should be completed at least 1 week prior to potential exposure.
Children ≧3 years and Adolescent: Refer to adult dosing.
Booster dose:Adolescents ≧17 years: Booster dose may be given prior to potential re-exposure if the primary series was completed >1 year previously.Note:The safety of booster doses in children and adolescents <17 years has not been established.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer`s labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer`s labeling.
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懷孕分級
Pregnancy Risk Factor |
FDA：B。XM，仿單：孕婦應避免使用。
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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 |
對疫苗中任何活性成分或任何賦形劑或殘留物(例如硫酸魚精蛋白(protamine sulphate)、甲醛、牛血清白蛋白、宿主細胞DNA、偏亞硫酸氫鈉(sodium metabisulphite)、宿主細胞蛋白)過敏者或先前於接種本疫苗之後出現過敏現象者，應避免施打。
有急性嚴重發熱症狀者應延後施打。
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| Contraindications |
U.S. labeling:Severe allergic reaction to a previous dose of the vaccine, any other Japanese encephalitis virus vaccine, or any component of the vaccine, including protamine sulfate
Canadian labeling:Hypersensitivity to a previous dose of the vaccine or to any component of the formulation; acute severe febrile conditions
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Percentage of adverse reactions reported over days 0-56 in adults and 0-7 in pediatric patients. In general, incidence decreased with subsequent dosing.
>10%:
Central nervous system: Headache (adults 28%; infants, children, and adolescents 2% to 5%), irritability (infants and children <3 years 8% to 15%; children ≧3 years and adolescents ≦2%), fatigue (adults 11%; infants, children, and adolescents 2% to 3%)
Gastrointestinal: Diarrhea (infants and children <3 years 7% to 12%; children ≧3 years, adolescents, and adults <1% to 2%)
Local: Tenderness at injection site (adults 36%; children ≧3 years and adolescents 4% to 10%; infants and children <3 years 3%), pain at injection site (adults 33%; children ≧3 years and adolescents 6% to 15%; infants and children <3 years 4%), erythema at injection site (infants and children <3 years 6% to 18%; adults 10%; children ≧3 years and adolescents ≦3%)
Neuromuscular & skeletal: Myalgia (adults 16%; infants, children, and adolescents 2% to 3%)
Respiratory: Flu-like symptoms (adults 12%; infants, children, and adolescents 1% to 8%)
Miscellaneous: Fever (infants and children <3 years 20% to 24%; children ≧3 years and adolescents 4% to 11%; adults 3%)
1% to 10%:
Dermatologic: Skin rash (infants and children <3 years 4% to 8%; children ≧3 years, adolescents, and adults ≦1%)
Gastrointestinal: Nausea (adults 7%, infants, children, and adolescents ≦2%), vomiting (infants and children <3 years 4% to 8%; children ≧3 years, adolescents, and adults 1% to 2%), decreased appetite (infants, children, and adolescents 1% to 6%)
Infection: Influenza (adults ≧1%)
Local: Induration at injection site (adults 8%; infants, children, and adolescents ≦1%), swelling at injection site (≦2% to 4%), itching at injection site (adults 4%; infants, children, and adolescents ≦1%)
Neuromuscular & skeletal: Back pain (adults 1%)
Respiratory: Nasopharyngitis (adults 5%), pharyngolaryngeal pain (adults 2%), upper respiratory tract infection (adults 2%), sinusitis (adults ≧1%), cough (adults 1%), rhinitis (adults 1%)
Miscellaneous: Febrile seizures (children <3 years 1%)
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★高警訊藥品
監測建議 |
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監測
Monitoring |
Observe for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). 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 |
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| 針劑施打條件 |
肌肉注射，一般於上臂肌肉(三角肌)接受注射。嬰兒則注射於大腿前外側。本品絕對不能注射到血管中。(1070309仿單資料)
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| 針劑保存安定性 |
冷藏2-8℃，避免凍結。存放於原包裝內避免光線照射。(1070309仿單資料)
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最近修改日期時間
Updated | 5/9/2018 10:22:47 AM |