藥品名稱
drug name | Zoster virus vaccine live (Oka/Merck), MSD (Zostavax, 伏帶疹 活性帶狀?疹疫苗) 19,400 PFU/0.65 mL/vial |
| 藥檔狀態 | 停用 （需冷藏） |
成 份
Ingredient | (PLAQUE-FORMING UNITS) OF OKA/MERCK STRAIN OF VZV |
| 單位含量 | 19,400 PFU/0.65 mL/vial |
| Dosage Forms | Solution Reconstituted, Subcutaneous : 19,400 units/0.65 mL (1 ea) |
| 外觀描述 | 針劑/注射 |
| Appearance | injection |
標 示
outward | |
廠商名稱
Manufacturer | 美商默沙東藥廠股份有限公司台灣分公司 |
製 造 商
Manufacturer | MERCK SHARP & DOHME LLC, U.S.A. |
字 號
Product ID | 衛署菌疫輸字第000873號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Live) |
作用機轉
Mechanism of action | A decline in VZV-specific immunity increases the risk of developing zoster infection. As a live, attenuated vaccine (Oka/Merck strain of varicella-zoster virus), zoster virus vaccine stimulates active immunity to disease caused by the varicella-zoster virus. Administration has been demonstrated to protect against the development of herpes zoster, with the highest efficacy in patients 60-69 years of age. It may also reduce the severity of complications, including postherpetic neuralgia, in patients who develop zoster following vaccination. |
| 用途/適應症 | 預防成人帶狀泡疹。 |
| Use |
Herpes zoster prevention: Prevention of herpes zoster (shingles) in patients ≧50 years of age
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衛福部核准適用症狀
MOHW approved indications |
預防50~79歲之成人帶狀?疹。
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| Dose |
Administration: SubQ
Adults ≧50 years: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine
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懷孕分級
Pregnancy Risk Factor |
X (仿單：懷孕為禁忌症。)
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| 禁忌症 |
1.曾對此疫苗的任何成分(包括明膠)產生過敏反應。
2.曾對Neomycin(每劑泡製後的疫苗含有微量的Neomycin)產生過敏/類過敏反應。不過，因使用Neomycin而發生接觸性皮膚炎的病史並非接種活性病毒疫苗的禁忌。
3.因下列疾病呈現原發性或後天性的免疫不全狀態：急慢性白血病、淋巴瘤、其他會侵犯骨隨或淋巴系統的疾病、HIV/AIDS所引起的免疫抑制、細胞性的免疫功能不全。
4.免疫抑制治療(包括高劑量的皮質類固醇)不過，Zostavax並不禁用於正在使用局部外用性/吸入性皮質類固醇或低劑量之全身用皮質類固醇的患著，或是正在使用皮質類固醇做為補充治療的患著，如腎上腺功能不全的患著。
5.未經治療的活動性結核病。
6.懷孕。
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| Contraindications |
History of anaphylactic/anaphylactoid reaction to gelatin, neomycin (excluding contact dermatitis to neomycin), or any other component of the vaccine; immunosuppression or immunodeficiency, including individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary and acquired immunodeficiency states; AIDS or clinical manifestations of HIV; those receiving immunosuppressive therapy (including high-dose corticosteroids); pregnancy.
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| 常見副作用 | 注射部位疼痛、發紅 和腫脹
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| Common adverse drug reactions | Injection site pain, redness and swelling |
| Adverse Reactions |
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Local: Pain at injection site (?54%), erythema at injection site (36% to 48%), swelling at injection site (26% to 40%), localized tenderness (?34%), injection site pruritus (7% to 11%)
1% to 10%:
Cardiovascular: Cardiac failure (≦2%)
Central nervous system: Headache (1% to 9%)
Gastrointestinal: Diarrhea (2%)
Local: Warm sensation at injection site (2% to 4%), hematoma at injection site (2%), induration at injection site (1%)
Neuromuscular & skeletal: Asthenia (1%), limb pain (1%)
Respiratory: Pulmonary edema (≦2%), respiratory tract disease (1%)
<1%, postmarketing, and/or case reports: Anaphylaxis, arthralgia, exacerbation of asthma, facial nerve paralysis, fever, Guillain-Barre syndrome, herpes zoster infection, hypersensitivity reaction, lymphadenopathy (transient), myalgia, nausea, necrotizing retinitis (patients on immunosuppressive therapy), polymyalgia rheumatica, rash at injection site, skin rash, urticaria at injection site, varicella zoster infection (in immunocompromised patients)
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監測
Monitoring |
Parameters Fever, rash; monitor for syncope for 15 minutes following administration. 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 | 配製後應立即使用。 |
| Warnings & precautions | Store in the refrigerator. |
| 針劑溶解條件 |
僅可使用原廠提供的稀釋液溶解。將針筒中稀釋液全部注入裝有冷凍乾燥疫苗的小瓶中，然後輕輕搖動使其混和均勻。
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| 針劑稀釋條件 |
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| 針劑不相容性 |
不可與任何其他藥物混用於同一支針筒中。
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| 針劑施打條件 |
1.僅供皮下注射使用。最好是注入上臂(以三角肌部位為佳)。
2.Zostavax可與去活性流感疫苗同時接種。
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| 針劑保存安定性 |
未開封：冷藏(2-8℃)儲存。自冰箱取出後應立即泡製。泡製後應立即施打，以免效價減弱。泡製後的疫苗若未在30分鐘內使用，應予拋棄。
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最近修改日期時間
Updated | 7/12/2023 10:23:23 AM |