藥品名稱
drug name | 莫德納次世代BA.1 (Spikevax) COVID-19 雙價疫苗 0.5ml/dose (12歲以上) |
| 藥檔狀態 | 停用 |
成 份
Ingredient | COVID-19 vaccine (mRNA) |
| 單位含量 | 0.5ml/dose |
| Dosage Forms | 每劑0.5ml含有25mcg原病毒株mRNA及25mcg變異株(Omicron,B.1.1.529)mRNA |
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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 protects against COVID-19 disease. |
| 用途/適應症 | 預防COVID-19 |
| Use |
Spikevax 雙價疫苗(原病毒株/Omicron BA.1)適用於12歲以上青少年及成人之主動免疫接種，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 |
Spikevax 雙價疫苗(原病毒株/Omicron BA.1)適用於12歲以上青少年及成人之主動免疫接種，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0.5cc
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
追加劑(可使用在Spikevax或其他授權的COVID-19原病毒株疫苗之基礎接種後或追加劑後，間隔至少3個月施打)
12歲以上青少年及成人：
50mcg (0.5mL)
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懷孕分級
Pregnancy Risk Factor |
懷孕：
懷孕期間可以接種Spikevax原病毒株疫苗。
哺乳：
哺乳期間可以接種Spikevax原病毒株疫苗。
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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 |
History of a severe allergic reaction (eg, anaphylaxis) after a previous dose or to a component of the formulation.
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| 常見副作用 | 注射部位疼痛、疲倦。 |
| Common adverse drug reactions | Injection site pain, Fatigue. |
| Adverse Reactions |
>10%:
Gastrointestinal: Decreased appetite (infants and children: 20% to 32%), , nausea and vomiting (Moderna: 5% to 24%)
Local: Erythema at injection site (2% to 20%), pain at injection site (27% to 95%), swelling at injection site (3% to 21%)
Nervous system: Chills (2% to 49%), drowsiness (infants and children: 20% to 37%), fatigue (25% to 68%), headache (5% to 70%), irritability (and/or crying; infants and children: 44% to 68%)
Neuromuscular & skeletal: Arthralgia (Moderna: 6% to 46%), axillary swelling (Moderna: Including axillary tenderness; 5% to 25%), myalgia (Moderna: 10% to 62%)
Miscellaneous: Fever (?24%)
1% to 10%:
Gastrointestinal: Abdominal pain (Moderna: 1%)
Hematologic & oncologic: Lymphadenopathy (?5%; unsolicited)
Hypersensitivity: Hypersensitivity reaction (Moderna: 2% to 5%; including rash at injection site, urticaria at injection site, and severe hypersensitivity reaction)
Local: Injection-site reaction (Moderna: Delayed-onset: 1% to 3%)
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監測
Monitoring |
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2022]; CDC 2022c). Observe patients for 30 minutes after vaccination in those patients with the following: a history of nonsevere, immediate (within 4 hours) allergic reaction after receipt of a COVID-19 vaccine; a history of anaphylaxis following receipt of a non–COVID-19 vaccine or injectable therapy; or a person with an allergy-related contraindication to a different type of COVID-19 vaccine (CDC 2022c). 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 |
不得與任何其他疫苗或藥品混合於同一注射器內施打。
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| 針劑施打條件 |
以肌肉注射方式施打，理想注射部位為上臂三角肌。
請勿以血管內注射、皮下注射或皮內注射方式施打本疫苗。
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| 針劑保存安定性 |
未開封多劑量藥瓶：
-50°C至-15°C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 | 11/22/2022 4:23:35 PM |