藥品名稱
drug name | BNT(BioNTech) COVID-19疫苗 0.2mL/dose (滿5-11歲兒童) |
| 藥檔狀態 | 停用 |
成 份
Ingredient | COVID-19 vaccine (mRNA) |
| 單位含量 | 0.2mL/dose |
| Dosage Forms | 0.2mL/dose |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | |
| Dose Form | |
大 小
Size | |
標 示
outward | |
廠商名稱
Manufacturer | BioNTech Manufacturing GmbH |
製 造 商
Manufacturer | BioNTech Manufacturing GmbH |
字 號
Product ID | 專案進口無字號 |
藥理分類
Pharmacologic Category | Vaccine; Vaccine, mRNA |
作用機轉
Mechanism of action | The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable
delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19. |
| 用途/適應症 | 預防COVID-19 |
| Use |
適用於5至11歲兒童之主動免疫接種，以預防新型冠狀病毒疾病(COVID-19，嚴重特殊傳染性肺炎)。
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衛福部核准適用症狀
MOHW approved indications |
適用於 5 至 11 歲兒童之主動免疫接種，以預防新型冠狀病毒疾病(COVID-19，嚴重特殊傳染性肺炎)。
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| 常用劑量 | 立刻使用0.2cc
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
10 微克(mcg)疫苗稀釋後進行肌肉內注射，基礎劑接種程序為先後施打 2 劑（每劑 0.2 mL），建議兩劑間隔至少 21 天。
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懷孕分級
Pregnancy Risk Factor |
仿單:接種疫苗對於孕婦和胎兒的潛在益處高於潛在風險
時，可考慮在懷孕期間接種本品。
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| 禁忌症 |
先前接種本疫苗時或對本疫苗任何成分曾發生嚴重過敏反應者。
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| Contraindications |
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
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| 常見副作用 | 注射部位紅腫，注射部位疼痛，疲倦 |
| Common adverse drug reactions | Erythema at injection site,Injection site pain,Fatigue |
| Adverse Reactions |
Dermatologic: Erythema at injection site (5 to 11 years, 15.6% to 26.4% ), Injection site pain (5 to 11 years, 73.9% to 84.3% ), Swelling at injection site (5 to 11 years, 16.4% to 20.4% )
Musculoskeletal: Arthralgia (5 to 11 years, 6.7% to 7.6% ), Myalgia (5 to 11 years, 17.5% to 18.3% )
Neurologic: Headache (5 to 11 years, 34% to 38.2% )
Other: Fatigue (5 to 11 years, 45.6% to 51.7% ), Fever (5 to 11 years, 6.7% to 8.3% ), Shivering (5 to 11 years, 10.5% to 12.4% )
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監測
Monitoring |
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| 警語與注意事項 | 疫苗接種後可能發生的反應大多為接種部位疼痛、紅腫，通常於數天內消失，可適度冰敷，請勿揉；抓接種部位。 |
| Warnings & precautions | Erythema or pain at injection site would disappear in days.Ice compress.Do not scratch or rubbing. |
| 針劑溶解條件 |
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| 針劑稀釋條件 |
注入 1.3mL 的 0.9%（9 mg/mL）氯化鈉注射液進行稀釋。
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| 針劑不相容性 |
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| 針劑施打條件 |
肌肉內注射
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| 針劑保存安定性 |
未開封的藥瓶:冷凍的藥瓶可在-90 °C 至-60 °C 下保存 12 個月。
解凍後的藥瓶:在 12 個月的保存期限內，可於 10 週內在 2°C 至 8°C 下進行保存和運送。
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最近修改日期時間
Updated | 7/4/2022 1:30:49 PM |