藥品名稱
drug name | BCG Vaccine 0.5 mg/amp (公費卡介苗疫苗) |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | BCG Vaccine 0.5 mg/amp (公費) |
| 單位含量 | 0.5 mg/amp |
| Dosage Forms | Injectable, Injection: 0.5mg/amp |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | 衛生福利部疾病管制署 |
製 造 商
Manufacturer | 財團法人國家衛生研究院生物製劑廠 |
字 號
Product ID | 衛署菌疫製字第000085號 |
藥理分類
Pharmacologic Category | Vaccine; Vaccine, Live (Bacterial) |
作用機轉
Mechanism of action | BCG vaccine is an attenuated, live bacterial culture of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis and induces active immunity against Mycobacterium tuberculosis. |
| 用途/適應症 | |
| Use |
Mycobacterium tuberculosis disease prevention: Active immunization against Mycobacterium tuberculosis in persons not previously infected and who are at high risk for exposure
|
衛福部核准適用症狀
MOHW approved indications |
預防結核病
|
| 常用劑量 |
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
[1090831仿單資料]：0.1ml (0.05mg)
【Geriatric】
Refer to adult dosing.
【Renal-impairment】
There are no dosage adjustments provided in the manufacturer`s labeling.
【Hepatic-impairment】
There are no dosage adjustments provided in the manufacturer`s labeling.
|
懷孕分級
Pregnancy Risk Factor |
依文獻內容判定系統稽核懷孕分級建置為：C
Animal reproduction studies have not been conducted. BCG vaccine is not recommended for use in pregnant women. Because of the theoretical risk to the fetus, women known to be pregnant generally should not receive live, attenuated virus vaccines (ACIP [Ezeanolue 2020]).
-----------------------------------------------------------
[FDA(美國食品及藥物管理局)懷孕分級說明:
A：對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B：動物試驗無法證實對胎兒有害，但缺乏人類對照試驗；或動物試驗有副作用報告，但無法證實對懷孕初期及後期之胎兒有害。
C：動物實驗中對胎兒有害但缺乏孕婦對照實驗；或無動物及孕婦試驗。
D：證實對胎兒有害，但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X：證實對胎兒有害，且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
|
| 禁忌症 |
1. 結核菌素測試陽性者。可疑之結核病患者勿直接接種卡介苗，應先做結核菌素測驗，另服用抗結核病藥物患者不適合注射卡介苗。
2. 早產兒或體重在2500克(g)以下之新生兒。
3. 患急性熱病、水痘感染與麻疹及其復原期者，全身性皮膚炎患者須暫緩接種。
4. 有免疫機能不全或有其家族史及其他經醫師診斷為不適於預防接種者。
5. 曾注射本品有過敏反應者。
6. 服用類固醇或受免疫抑制治療者(輻射治療者)、罹患淋巴瘤、白血病、帕金氏症或其他網狀內皮系統癌或具有免疫缺陷患者(如愛滋病，包含愛滋帶原母親所生嬰兒)。這些患者在BCG接種後可能會引起強烈的反應，甚至引發瀰漫性卡介苗感染症。
|
| Contraindications |
Prior hypersensitivity to the vaccine or any component of the formulation; immunosuppressed patients or persons with congenital or acquired immune deficiencies (eg, HIV infection, leukemia, lymphoma, cancer therapy, immunosuppressive therapy such as corticosteroids); active tuberculosis
|
| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Local reactions may persist for up to 3 months; more severe manifestations may occur up to 5 months after vaccination and persist for several weeks.
Frequency not defined:
Dermatologic: Pustules (at injection site), skin ulceration at injection site
Hematologic & oncologic: Cervical lymphadenopathy, lymphadenitis (includes local and suppurative), lymphadenopathy (axillary)
Infection: BCG infection (BCG osteomyelitis; may occur from 4 months to 2 years after vaccination)
Local: Induration at injection site, injection site lesion, itching at injection site, tenderness at injection site
Respiratory: Flu-like symptoms
|
★高警訊藥品
監測建議 |
|
監測
Monitoring |
PPD test prior to vaccination. Flu-like symptoms ≧72 hours, fever ≧103°F, acute local reactions lasting >2 to 3 days. Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). 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 | |
| Warnings & precautions | |
| 針劑溶解條件 |
[1090831仿單資料]
用滅菌乾燥注射器，取適量稀釋液，徐徐注入疫苗安瓿中，輕搖數次直到裡頭的凍乾卡介苗粉末完全回溶為止，成為0.5mg/mL之懸浮液。每次抽取前應輕輕搖動安瓿，使之均勻分佈並呈現乳白不透明狀。
|
| 針劑稀釋條件 |
|
| 針劑不相容性 |
|
| 針劑施打條件 |
[1090831仿單資料]
肱骨上方三角肌末端位置(位置接近上手臂算起1/3處進行皮內注射)
|
| 針劑保存安定性 |
[1090831仿單資料]
本品應置於滅菌之中性茶褐色安瓿內，於8℃以下遮光保存，高溫放置效價驟減。
每安瓿一經打開稀釋後應立即使用，必須二小時內用完並持續保冷(2~4℃)及避光儲存。
稀釋液亦應低溫保存，因其溫變若超過25℃易使疫苗凝集及效價降低。
|
最近修改日期時間
Updated | 8/31/2020 3:37:17 PM |