藥品名稱
drug name | 阿斯特捷利康(AstraZeneca) COVID-19疫苗 5mL/vial (18歲以上) |
| 藥檔狀態 | 停用 |
成 份
Ingredient | COVID-19 vaccine |
| 單位含量 | 0.5mL/dose |
| Dosage Forms | 5mL/vial，0.5mL/dose |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | 針劑/注射 |
| Dose Form | |
大 小
Size | |
標 示
outward | |
廠商名稱
Manufacturer | 阿斯特捷利康(AstraZeneca) |
製 造 商
Manufacturer | 阿斯特捷利康(AstraZeneca) |
字 號
Product ID | 專案進口 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Adenovirus Vector |
作用機轉
Mechanism of action | Promotes active immunity against COVID-19 caused by SARS-CoV-2 virus. The adenovirus vector in the vaccine is a recombinant, replication-incompetent adenovirus vector that expresses the SARS-CoV-2 spike (S) antigen without virus propagation. The vaccine then elicits an immune response to the S antigen, which contributes to protection against COVID-19 disease (FDA 2021; AstraZeneca Canadian product monograph). The Janssen vaccine contains a human adenovirus type 26 (Ad26) vector (FDA 2021). The AstraZeneca vaccine and Covishield [Canadian products] contain a chimpanzee adenovirus (ChAdOx1) vector (AstraZeneca Canadian product monograph; Covishield Canadian product monograph). |
| 用途/適應症 | 預防COVID-19 |
| Use |
Active immunization to prevent COVID-19 in persons ≧18 years of age.
|
衛福部核准適用症狀
MOHW approved indications |
阿斯特捷利康(AstraZeneca) 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 |
仿單：
- 先後施打兩次(肌肉注射)，每劑0.5mL；第一劑注射與第二劑應間隔4至12週 (28至84天)。
- 嚴重特殊傳染性肺炎中央流行疫情指揮中心建議二劑間隔8-12週。
【Pediatric】:
仿單：
- 尚未確立阿斯特捷利康(AstraZeneca) COVID-19 疫苗用於兒童和青少年 (<18歲) 的安全性及效力，目前尚無資料。
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懷孕分級
Pregnancy Risk Factor |
仿單：阿斯特捷利康(AstraZeneca) COVID-19 疫苗用於懷孕女性的經驗有限。
動物生殖毒性試驗尚未完成。根據初步試驗結果，未觀察到對胎兒發育的影響。
除非可能效益高於對母親和胎兒的潛在風險，否則懷孕期間不應施打阿斯特捷利康(AstraZeneca) COVID-19 疫苗。
Lactation:目前並不清楚阿斯特捷利康(AstraZeneca) COVID-19 疫苗是否會分泌到人類乳汁中。
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| 禁忌症 |
對有效成分或任何賦型劑過敏
|
| Contraindications |
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| 常見副作用 | 施打部位疼痛，頭痛，疲倦 |
| Common adverse drug reactions | Pain at injection site,Headache,Fatigue |
| Adverse Reactions |
>10%:
- Gastrointestinal: Nausea (6% to 24%)
- Local: Pain at injection site (10% to 60%), tenderness at injection site (32% to 79%), warm sensation at injection site (4% to 17%)
- Nervous system: Chills (2% to 37%), fatigue (27% to 65%), headache (20% to 61%), malaise (10% to 48%)
- Neuromuscular & skeletal: Arthralgia (7% to 28%), myalgia (14% to 52%)
- Miscellaneous: Fever (≦12%; feverishness: 4% to 39%)
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監測
Monitoring |
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). Observe patients for 30 minutes after vaccination in 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 2021a). 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 2021a).
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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 | Pain and erythema at injection site are the most probably side effects which usually disappear in few days. |
| 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 |
不可與其他疫苗或藥品在同一注射器內混合使用。
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| 針劑施打條件 |
肌肉注射(最好注射於上臂的三角肌)。不可在血管內、皮下或皮內注射。
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| 針劑保存安定性 |
未開封：儲存於2~8°C月。不可冷凍。將藥瓶置於外盒內，避光儲存。
開封後：應立即使用。若未立即使用，應確保疫苗在不超過30°C狀況下，不超過6小時)。
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最近修改日期時間
Updated | 9/26/2022 9:04:06 AM |