藥品名稱
drug name | RZV Recombinant Zoster Vaccine (Shingrix, 欣剋疹帶狀泡疹疫苗) 50mcg/0.5mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Varicella Zoster Virus glycoprotein E |
| 單位含量 | 50mcg/0.5mL/vial |
| Dosage Forms | 50mcg/0.5mL/vial |
| 外觀描述 | 針劑/肌肉注射 |
| Appearance | injection/IM |
標 示
outward | |
廠商名稱
Manufacturer | 荷商葛蘭素史克藥廠股份有限公司台灣分公司 |
製 造 商
Manufacturer | GLAXOSMITHKLINE BIOLOGICALS S.A.,BELGIUM |
字 號
Product ID | 衛部菌疫輸字第001182號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated) |
作用機轉
Mechanism of action | Stimulates active immunity to disease caused by reactivation of the varicella-zoster virus, thereby protecting against zoster disease (shingles) and associated complications (eg, postherpetic neuralgia [PHN]). |
| 用途/適應症 | 預防成人帶狀泡疹。 |
| Use |
Herpes zoster prevention
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衛福部核准適用症狀
MOHW approved indications |
適用於下列對象，以預防帶狀泡疹及其相關併發症，如泡疹後神經痛(post-herpetic neuralgia, PHN)：
- 50歲(含)以上的成人
- 18歲(含)以上且具有罹患帶狀泡疹風險較高的成人
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| Dose |
Administration: IM
preferably in the deltoid muscle. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle)
Shingles prevention:
Adults ≧18 years of age (immunocompromised [current or future]): 0.5 mL administered as a 2-dose series at 0 and 1 to 2 months.
Adults ≧50 years of age (immunocompetent): 0.5 mL administered as a 2-dose series at 0 and 2 to 6 months.
CDC/ACIP recommendations: If the second dose is delayed or interrupted, the series does not need to be restarted. If the interval between dose 1 and 2 is <4 weeks, then the second dose should be repeated (CDC/ACIP [Anderson 2022]; CDC/ACIP [Dooling 2018]).
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懷孕分級
Pregnancy Risk Factor |
已知懷孕的婦女應避免接種Shingrix疫苗。
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| 禁忌症 |
禁用於對疫苗的活性成份或任何組成嚴重過敏者
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| Contraindications |
Severe hypersensitivity (eg, anaphylaxis) to recombinant zoster vaccine or any component of the formulation.
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| 常見副作用 | 注射部位反應、肌肉痛、疲倦、頭痛、發燒、腸胃不適 |
| Common adverse drug reactions | Injection site reaction, myalgia, fatigue, headache, fever, GI adverse effects |
| Adverse Reactions |
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: GI adverse effects (13%-24%)
Local: Erythema at injection site (20%-39%), pain at injection site (69%-88%), swelling at injection site (10%-31%)
Nervous system: Fatigue (37%-57%), headache (15%-51%), shivering (11%-36%)
Neuromuscular & skeletal: Myalgia (35%-57%)
Miscellaneous: Fever (6%-28%; including high fever)
1% to 10%:
Dermatologic: Injection site pruritus (2%)
Gastrointestinal: Nausea (1%)
Nervous system: Chills (4%), dizziness (1%), malaise (2%)
Neuromuscular & skeletal: Arthralgia (2%)
Respiratory: Flu-like illness (1%), pneumonia (2%)
<1%:
Endocrine & metabolic: Gout (including gouty arthritis)
Hematologic & oncologic: Lymphadenitis
Ophthalmic: Optic neuropathy
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監測
Monitoring |
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2022]). 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 | |
| Warnings & precautions | |
| 針劑溶解條件 |
1. 將裝有懸液之小瓶中的全部內容物抽入針筒。
2. 將針筒中的全部內容物加入裝有粉末的小瓶中。
3. 輕輕振搖，直到粉末完全溶解。
泡製後的疫苗為帶有乳白色光澤、無色至淡棕色的液體。
如果發現微粒異物及/或外觀改變的現象，勿施打疫苗。
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| 針劑稀釋條件 |
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| 針劑不相容性 |
本疫苗不能與其他藥品混合使用。
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| 針劑施打條件 |
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| 針劑保存安定性 |
未開封: 保存在冷藏2-8°C，不得冷凍。請置於原始包裝中保存，避光保存。
泡製後: 立即使用；如無法立即使用，應將疫苗存放於冰箱中(2-8°C)，並於6 小時內使用。
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最近修改日期時間
Updated | 1/10/2024 10:10:25 AM |