藥品名稱
drug name | Zoster virus vaccine live (Oka/Merck), MSD (Zostavax®, 伏帶疹 活性帶狀疱疹疫苗) |
| 藥檔狀態 | 使用中 |
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 Forms | 19,400 units/0.65 mL (1 ea) |
| 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 | 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 | Immunologic Agents and Vaccines, Live (Viral)/Agents for Active Immunity / |
作用機轉
Mechanism of action | Adults ≥50 years: SubQ: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine |
| 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歲之成人帶狀疱疹。
|
| 常用劑量 | 立刻使用1vial
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| 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 |
Hypersensitivity to any component of the vaccine; individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary and acquired immunodeficiency states including AIDS or clinical manifestations of HIV; those receiving immunosuppressive therapy (including high-dose corticosteroids); pregnancy
|
| 常見副作用 | 發燒，注射部位紅腫痛。 |
| Common adverse drug reactions | fever, injection site pain/erythema/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 | 請冷藏存放。接種後2-4週內若發生水泡型紅疹（類似水痘），身體不適或發燒請盡速回診就醫 |
| Warnings & precautions | should be refrigerated between 2-8 ℃. |
| 針劑溶解條件 |
預充針筒稀釋液：將針筒中的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，使其混合均勻。
|
| 針劑稀釋條件 |
|
| 針劑不相容性 |
|
| 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。
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最近修改日期時間
Updated | 2/4/2015 6:21:53 PM |