藥品名稱
drug name | 莫德納 (Moderna) COVID-19疫苗 5mL/vial (18歲以上) |
| 藥檔狀態 | 停用 |
成 份
Ingredient | COVID-19 vaccine (mRNA) |
| 單位含量 | 5mL/vial，0.5mL/dose |
| Dosage Forms | 5mL/vial，0.5mL/dose |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | 針劑/小瓶 |
| 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 |
莫德納 (Moderna) COVID-19 疫苗適用於18歲以上青少年及成人之主動免疫接種，以預防2019年冠狀病毒疾病(COVID-19，及本國法規所稱「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 |
莫德納 (Moderna) COVID-19 疫苗適用於18歲以上青少年及成人之主動免疫接種，以預防2019年冠狀病毒疾病(COVID-19，及本國法規所稱「嚴重特殊傳染性肺炎」)。
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| 常用劑量 | 立刻使用0.5cc
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
0.5 mL per dose for 2 doses administered 28 days apart
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懷孕分級
Pregnancy Risk Factor |
仿單：
孕婦施打莫德納COVID-19疫苗的實際案例數量有限，動物研究尚未顯示本疫苗會對懷孕、胚胎/胎兒發育、分娩或產後發育造成直接或間接有害的影響。於懷孕期間，唯有施打莫德納COVID-19疫苗對母親或胎兒的潛在益處高於任何潛在風險時，才應考慮施打本疫苗。
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| 禁忌症 |
對本疫苗所含之活性物質或內含任一賦形劑過敏。
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| Contraindications |
History of a severe allergic reaction (eg, anaphylaxis) after a previous dose or to a component of the formulation; history of immediate allergic reaction (regardless of severity and occurring within 4 hours) to a previous dose; known allergy to any component of the formulation
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| 常見副作用 | 注射部位疼痛，疲倦，頭痛 |
| Common adverse drug reactions | Injection site pain,Fatigue,Headache |
| 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.
Antibody testing to assess for SARS-CoV-2 immunity following vaccination is not currently recommended (CDC 2021c).
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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 | Injection site pain and redness would disapear in few days.Cooling but do not scratch or rub. |
| 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 |
本藥品不可與其他藥品混和或進行稀釋。
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| 針劑施打條件 |
肌肉注射。理想注射部位為上臂三角肌。不可在血管內、皮下或皮內注射。
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| 針劑保存安定性 |
‧ -25~-15℃冷凍保存，可保存7個月。
‧ 不得低於-40°C且不得使用乾冰冷運冷儲。請保存於原包裝盒中，避免光照。
‧ 若轉置到2-8℃冷藏設備保存必須於30天內使用完畢。
解凍時間：
‧ 在2-8℃的冷藏條件下解凍2小時30分鐘。 給藥前讓每個小瓶在室溫下靜置15分鐘。
或
‧ 在 15-25℃的室溫下解凍 1小時。
解凍後未開封瓶：
‧ 冷藏於2-8℃下，最長保存期限為30天。
‧ 室溫保存於8-25℃，保存期限為12天。
‧ 一旦解凍之疫苗，便不可再次冷凍
解凍後已抽液藥瓶：
‧ 冷藏或室溫下，最長保存期限為6小時。
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最近修改日期時間
Updated | 9/26/2022 9:02:13 AM |