藥品名稱
drug name | 莫德納 (Spikevax) COVID-19 疫苗 0.25ml/dose (6個月-5歲) |
| 藥檔狀態 | 停用 |
成 份
Ingredient | COVID-19 vaccine (mRNA) |
| 單位含量 | 0.25ml/dose |
| Dosage Forms | 0.25ml/dose |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | |
| Dose Form | |
大 小
Size | |
標 示
outward | |
廠商名稱
Manufacturer | Moderna US, Inc. |
製 造 商
Manufacturer | Moderna US, Inc. |
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 | Promotes active immunization against COVID-19 caused by SARS-CoV-2 virus. The modified messenger RNA (mRNA) in the vaccine is formulated in lipid particles that enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 spike (S) antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the S antigen, which may contribute to protection against COVID-19 disease |
| 用途/適應症 | 預防COVID-19 |
| Use |
Spikevax 適用於 6 個月以上兒童、青少年及成人的主動免疫接種，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 |
Spikevax 適用於 6 個月以上兒童、青少年及成人的主動免疫接種，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0.25cc
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
共須施打 2 劑各25 微克（每劑0.25 毫升，含25 微克 mRNA）
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懷孕分級
Pregnancy Risk Factor |
仿單:大量的觀察性資料顯示，孕婦在第二與第三孕期接種 Spikevax 並未增加不良懷孕結果。雖然在第一孕期接種的懷孕結果資料有限，但是並未發現流產風險有上升的現象。動物試驗並未顯示本疫苗會對懷孕、胚胎／胎兒發育、分娩或產後發育會造成直接或間接有害的影響。懷孕期間可以接種 Spikevax。
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| 禁忌症 |
對本疫苗所含之活性物質或所列之任一賦形劑嚴重過敏。
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| Contraindications |
A severe allergic reaction (eg, anaphylaxis) to a previous COVID-19 vaccine dose or to a component of the vaccine or a known (diagnosed) allergy to a component of the vaccine.
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| 常見副作用 | 注射部位疼痛，肌肉痛，疲倦 |
| Common adverse drug reactions | Injection site pain,Myalgia,Fatigue |
| Adverse Reactions |
>10%:
- Gastrointestinal: Diarrhea, nausea and vomiting (Moderna: 5% to 21%)
- Local: Pain at injection site (66% to 90%), swelling at injection site (4% to 13%)
- Nervous system: Chills (5% to 49%) (table 5), fatigue (33% to 68%) (table 6), headache (25% to 65%)
- Neuromuscular & skeletal: Arthralgia (Moderna: 16% to 46%), axillary swelling (Moderna: Including axillary tenderness; 6% to 16%), myalgia (Moderna: 20% to 62%)
- Miscellaneous: Fever (≦20%)
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監測
Monitoring |
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2021]; CDC 2021c). Observe patients for 30 minutes after vaccination in those patients with the following: a history of anaphylaxis (due to any cause); a history of an allergic reaction of any severity within 4 hours of receipt of a vaccine or injectable therapy; or a person with a contraindication to a different type of COVID-19 vaccine (CDC 2021c). 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 | 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 |
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| 針劑不相容性 |
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| 針劑施打條件 |
本疫苗應以肌肉注射方式施打，理想注射部位為上臂三角肌，嬰幼兒則為大腿前外側。
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| 針劑保存安定性 |
未開封多劑量藥瓶：
0.10 毫克/毫升 濃度: -50oC to -15oC. 條件下可保存 9 個月。
未開封疫苗冷藏存放於 2°C 至 8°C、避免光照，最多可保存 30 天。
未開封疫苗從冷藏條件取出後，可放置於 8°C 至 25°C 長達 24 小時。
本藥品首次抽液後，在 2°C 至 25oC 條件下可維持 19 小時的化學及物理穩定性
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最近修改日期時間
Updated | 9/26/2022 8:59:21 AM |