藥品名稱
drug name | MVC FLU Quadrivalent pre-filled syringe injection 0.5 mL/syringe 高端四價流感疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | A/Victoria/2570/2019 (H1N1), B/Phuket/3073/2013 (B/Yamagata lineage), B/Washington/02/2019 (B/Victoria lineage), A/Hong Kong/2671/2019 (H3N2) |
| 單位含量 | 0.5 mL/syringe |
| Dosage Forms | 0.5 mL/syringe |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | |
| Dose Form | |
大 小
Size | |
標 示
outward | |
廠商名稱
Manufacturer | 高端疫苗生物製劑股份有限公司 |
製 造 商
Manufacturer | 高端疫苗生物製劑股份有限公司 |
字 號
Product ID | 衛部菌疫製字第000151號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated) |
作用機轉
Mechanism of action | Promotes immunity to seasonal influenza virus by inducing specific antibody production. Preparations from previous seasons must not be used. |
| 用途/適應症 | 公費四價流感疫苗 |
| Use |
適用於3歲以上兒童及成人之主動免疫接種，藉以預防此疫苗所涵蓋之兩種A型流感病毒及兩種B型流感病毒所引起的流行性感冒。
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衛福部核准適用症狀
MOHW approved indications |
適用於3歲以上兒童及成人之主動免疫接種，藉以預防此疫苗所涵蓋之兩種A型流感病毒及兩種B型流感病毒所引起的流行性感冒。
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| 常用劑量 | 立刻使用1syr
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
3歲以上兒童及成人：肌肉注射一劑0.5毫升。建議施打部位為上臂三角肌。三角肌肌肉量不足的幼兒可施打於大腿前外側。
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懷孕分級
Pregnancy Risk Factor |
本品疫苗的臨床試驗未曾評估孕婦接種本品疫苗的安全性，然而，目前已上市的去活化流感疫苗(以雞蛋培養而得)已知可在懷孕的任何期間接種；相較於妊娠第一期，妊娠第二期和第三期有較多的安全性資料。
可能懷孕或有計畫懷孕之女性於接種前應請臨床醫師評估個案之利益是否大於風險。
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| 禁忌症 |
曾因任何疫苗成分引發嚴重過敏反應 (例如過敏性休克)者，不得施打高端四價流感疫苗
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| Contraindications |
Severe allergic reaction (eg, anaphylaxis) to a previous influenza vaccination or to any component of the formulation.
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| 常見副作用 | 疼痛，疲勞，肌肉痛 |
| Common adverse drug reactions | Pain,Fatigue,Myalgia |
| Adverse Reactions |
>10%:
●Gastrointestinal:
Anorexia (infants, children, and adolescents: 9% to 32%; adults and older adults: 4% to 8%), diarrhea (4% to 24%), nausea (≦12%), vomiting (infants, children, and adolescents:≦15%; adults and older adults:≦3%)
●Local:
Erythema at injection site (1% to 37%), induration at injection site (≦17%), pain at injection site (17% to 67%), swelling at injection site (≦25%), tenderness at injection site (21% to 69%)
●Nervous system:
Drowsiness (infants and children: 8% to 38%), fatigue (≦22%), headache (1% to 27%), irritability (infants and children: 2% to 54%), malaise (≦38%), uncontrolled crying (infants and children: 33% to 41%)
●Neuromuscular & skeletal:
Arthralgia (4% to 15%), myalgia (3% to 40%)
●Respiratory:
Cough (infants, children, and adolescents: 1% to 15%), rhinorrhea (infants and children: 1% to 11%), wheezing
●Miscellaneous:
Fever (infants, children, and adolescents: 1% to 16%; adults and older adults: ≦4%)
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監測
Monitoring |
Monitor for anaphylaxis and syncope for 15 minutes following administration. 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 | 限3歲以上幼兒及符合公費疫苗之成人對象使用 |
| Warnings & precautions | For 3 years old above who are elligible for government-funded vaccines. |
| 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，建議施打部位為上臂三角肌。
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| 針劑保存安定性 |
儲存溫度為2-8℃。
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最近修改日期時間
Updated | 9/21/2023 11:09:24 AM |