藥品名稱
drug name
Tuberculin PPD (Tuberculin PPD RT 23 SSI, 精製結核菌素 RT23SSI) 2 TU/0.1 mL, 30 TU/1.5 mL/vial
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Tuberculin Purified Protein Derivative RT 23 SSI
單位含量2 TU/0.1 mL, 30 TU/1.5 mL/vial
Dosage FormsSolution, Intradermal: 2 units/0.1 mL (1.5 mL)
外觀描述 針劑/皮內注射
Appearanceinjection/ intra-dermal
標  示
outward
紅色瓶蓋
廠商名稱
Manufacturer
國光生物科技股份有限公司
製 造 商
Manufacturer
AJ Vaccines A/S, DENMARK
字  號
Product ID
衛署菌疫輸字第000736號
藥理分類
Pharmacologic Category
Diagnostic agents/ Non- Radiopaque Contrast Agents/ Skin Test
作用機轉
Mechanism of action
Tuberculosis results in individuals becoming sensitized to certain antigenic components of the M. tuberculosis organism. Culture extracts called tuberculins are contained in tuberculin skin test preparations. Upon intracutaneous injection of these culture extracts, a classic delayed (cellular) hypersensitivity reaction occurs. This reaction is characteristic of a delayed course (peak occurs >24 hours after injection, induration of the skin secondary to cell infiltration, and occasional vesiculation and necrosis). Delayed hypersensitivity reactions to tuberculin may indicate infection with a variety of nontuberculosis mycobacteria, or vaccination with the live attenuated mycobacterial strain of M. bovis vaccine, BCG, in addition to previous natural infection with M. tuberculosis.
用途/適應症試驗結核菌素反應
Use Tuberculosis skin test: An aid in the diagnosis of tuberculosis (TB) infection.
衛福部核准適用症狀
MOHW approved indications
試驗結核菌素反應。
Dose Dosing: Adult
仿單:建議以含量為 2T.U./0.1mL 之精製結核菌素 RT 23 SSI,使用一劑量 0.1mL 在前臂三分之二處皮內注射 (而在手腕及手肘關節附近的反應較弱)。

【孟陀氏試驗法之評定】
(一) 判讀時間:注射後 48-72 小時
(二) 判讀方法:
用右手食指輕摸反應硬結(induration)之邊緣,以公釐(mm) 尺測量其橫徑(即與前臂長徑垂直方向之長度)。台灣地區陽性的判讀標準建議:
1.≧5mm:人類免疫不全病毒感染、惡性疾病、器官移植與其他免疫功能不全病患( 包括類固醇治療劑量相當於 15mg/day prednislone以上超過一個月)。
2. ≧10mm:>6歲兒童且與最近卡介苗注射時間間隔>6年、或未曾接種卡介苗、或具有如下述罹患結核病之危險因素者。
(1)最近接觸具傳染性之結核病患。
(2) 有結核病家族史。
(3) 糖尿病、慢性腎衰竭、胃部切除、小腸繞道手術等高危
險臨床狀況。
(4) 生長遲帶、營養不良。
(5) 胸部X光有疑似肺結核感染之變化。
(6) 注射藥癮。
3. ≧15mm:曾經接種卡介苗,並且≦6歲或最近卡介苗注射時間間隔≦6年,並且不具有罹患結核病之危險因素(如前項所述)。
懷孕分級
Pregnancy Risk Factor
C。
仿單:可在懷孕與授乳期間以精製結核菌素 RT 23 SSI 進行測試。
禁忌症 曾經使用 Sensitin PPD 或 Tuberculin PPD 注射於皮膚後,有顯著過敏反應者,不可再度使用這些產品。
Contraindications Hypersensitivity to tuberculin purified protein derivative (PPD) or any component of the formulation; previous severe reaction to tuberculin PPD skin test (TST); documented active TB or clear history of treatment for TB infection or disease; extensive burns or eczema.
常見副作用注射部位疼痛、搔癢或刺激感、水泡、輕微發燒。
Common adverse drug reactionsPain at injection site, local pruritus, localized vesiculation, fever.
Adverse Reactions Frequency not defined:

Cardiovascular: Presyncope, syncope

Dermatologic: Erythematous rash, localized erythema, localized vesiculation, rash at injection site, skin rash, skin ulceration at injection site, urticaria at injection site

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioedema, hypersensitivity reaction

Local: Injection site reactions, discomfort at injection site, hematoma at injection site, injection site scarring, local pruritus, localized edema, local tissue necrosis, pain at injection site

Respiratory: Dyspnea, stridor

Miscellaneous: Fever
監測
Monitoring
Monitor for immediate hypersensitivity reactions for ~15 minutes following injection.
警語與注意事項皮內注射。冷藏保存;不可口服。
Warnings & precautions2-8 °C, protect from light.
針劑溶解條件
針劑稀釋條件
針劑不相容性
針劑施打條件 皮內注射。
避免皮下或肌肉注射,若不慎注射方式錯誤,請於另一隻手臂或同手臂但距離前次注射部位至少 4cm 處再次進行皮內注射。(1080710仿單資料)
針劑保存安定性 未開封:冷藏避光儲存,避免凍結。
抽取第一劑後,要放回攝氏2度到8度之間遮光儲存,並須於24小時內使用完畢。(1080710仿單資料)
最近修改日期時間
Updated
7/10/2019 12:20:34 PM
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