藥品名稱
drug name
Zoster virus vaccine live (Oka/Merck), MSD (ZostavaxR, 伏帶疹 活性帶狀泡疹疫苗)
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
(PLAQUE-FORMING UNITS) OF OKA/MERCK STRAIN OF VZV
單位含量19,400 units/0.65 mL (1 ea)
Dosage FormsSolution Reconstituted, Subcutaneous : 19,400 units/0.65 mL (1 ea)
外觀描述 針劑/注射
Appearanceinjection
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 CORP.,UNITED STATES
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 Prevention of herpes zoster in patients ?50 years of age.
衛福部核准適用症狀
MOHW approved indications
預防50~79歲之成人帶狀泡疹。
Dose Adults ≧50 years: SubQ: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine
懷孕分級
Pregnancy Risk Factor
懷孕為仿單禁忌症。
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。
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.
常見副作用注射部位疼痛、發紅 和腫脹
Common adverse drug reactionsInjection site pain, redness and swelling
Adverse Reactions >10%:
Local: Injection site reaction (48% to 64%; includes erythema, tenderness, pain, swelling, hematoma, pruritus, and/or warmth)

1% to 10% (Note: Rates similar to placebo):
Central nervous system: Fever (2%), headache (1% to 9%)
Dermatologic: Skin disorder (1%)
Gastrointestinal: Diarrhea (2%)
Neuromuscular & skeletal: Weakness (1%)
Respiratory: Respiratory tract infection (2%), rhinitis (1%)
Miscellaneous: Flu-like syndrome (2%)
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.
警語與注意事項配製後應立即使用。
Warnings & precautionsStore 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。
針劑稀釋條件
針劑不相容性 不可與任何其他藥物混用於同一支針筒中。
針劑施打條件 僅供皮下注射使用。最好是注入上臂(以三角肌部位為佳)。
針劑保存安定性 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。
最近修改日期時間
Updated
1/11/2019 3:02:48 PM
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