藥品名稱
drug name
Diphtheria, Tetanus Toxoids & Pertussis Toxoid (Boostrix, 補施追疫苗) 0.5 mL/syringe
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Diphtheria, Tetanus Toxoids & Pertussis Toxoid
單位含量0.5 mL/syringe
Dosage FormsInjection: 0.5 mL
外觀描述 針劑/肌肉注射
Appearanceinjection/IM
標  示
outward
廠商名稱
Manufacturer
荷商葛蘭素史克藥廠股份有限公司台灣分公司
製 造 商
Manufacturer
GLAXOSMITHKLINE BIOLOGICALS S.A.,BELGIUM
字  號
Product ID
衛署菌疫輸字第000751號
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Toxoids and Vaccine
作用機轉
Mechanism of action
Promotes active immunity to diphtheria, tetanus, and pertussis by inducing production of specific antibodies.
用途/適應症三合一補追疫苗
Use Boostrix: Active booster immunization against diphtheria, tetanus, and pertussis in persons ≧4 years
衛福部核准適用症狀
MOHW approved indications
Boostrix適用於四歲以上者之追加疫苗接種,以預防白喉、破傷風及百日咳。
Dose IM, 0.5 mL as a single dose

【仿單】:
本疫苗的建議施打劑量為單劑 0.5 毫升。
須追加接種百日咳疫苗時,可根據當地現行減量白喉-破傷風混合疫苗追加接種計劃來接種 Boostrix。 對疫苗接種狀態不明或未完成白喉、破傷風、百日咳及小兒麻痺免疫接種系列中之白喉、破傷風與百日咳疫苗 接種的青少年與成人,可施打 Boostrix。
根據成人的資料,建議於施打第一劑的一個月後與六個月後分別再施打一劑含有白喉與破傷風類毒素成分的疫苗,藉以增強對抗白喉與破傷風的疫苗反應。
過去曾完成破傷風類毒素疫苗基礎接種的病人,在處置因受傷而有感染破傷風之虞可接種 Boostrix。是否同時施打破傷風免疫球蛋白應遵照政府建議。
懷孕分級
Pregnancy Risk Factor
B/C (manufacturer specific)

Lactation: Excretion in breast milk unknown/use caution.
禁忌症 1.不應用於已知對此疫苗任何成分嚴重過敏者,或先前曾於接種白喉、破傷風或百日咳疫苗之後出現嚴重過敏徵兆者。如果接種者曾經在接種含有百日咳抗原之疫苗後的七天內,發生病因不明的腦病變,則應禁用 Boostrix。在這些情況下,應停止接種百日咳疫苗,並應繼續接種白喉及破傷風疫苗。
2.對先前接種白喉及(或)破傷風疫苗後發生暫時性血小板減少。
Contraindications Hypersensitivity to diphtheria, tetanus toxoids, pertussis, or any component of the formulation; progressive neurologic disorder, including infantile spasms; encephalopathy occurring within 7 days of a previous dose of a pertussis-containing vaccine and not attributable to another cause
常見副作用注射部位疼痛;頭痛、疲倦、腸胃不適
Common adverse drug reactionsInjection site pain;headache, fatigue, GI discomfort.
Adverse Reactions Adverse reactions may be reported with use of other concomitant vaccines. Adverse reactions occurred with adolescents and adults unless otherwise specified.

>10%:
Cardiovascular: Hypoactivity (children: ≦51%)
Central nervous system: Headache (30% to 44%; older adults: 12%), fatigue (24% to 37%; older adults: 13%), malaise (33%), body pain (≦30%), myasthenia (≦30%), chills (8% to 15%)
Endocrine & metabolic: Increased arm circumference (adolescents: 28%; adults: <1%)
Gastrointestinal: Gastrointestinal symptoms (adolescents: 26%; adults: 8% to 16%), nausea (9% to 13%)
Local: Pain at injection site (61% to 87%; older adults: 22%), erythema at injection site (6% to 25%; older adults: 11%), swelling at injection site (7% to 21%; older adults: 8%)
Neuromuscular & skeletal: Myalgia (58%), arthralgia (≦15%), joint swelling (≦15%)
Miscellaneous: Fever (≦14%; older adults: 2%)

1% to 10%:
Dermatologic: Skin rash (2% to 3%)
Gastrointestinal: Diarrhea (10%), vomiting (3% to 5%)
Hematologic & oncologic: Benign lymph node hyperplasia (7%)
監測
Monitoring
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.
警語與注意事項適用於4歲以上者之追加疫苗接種,肌肉注射。
Warnings & precautions適用於4歲以上者之追加疫苗接種,肌肉注射。
針劑溶解條件 不需溶解。
針劑稀釋條件 不需溶稀釋。
針劑不相容性 不應與其他疫苗混合於同一針筒中使用。
針劑施打條件 肌肉注射。(1080426仿單資料)
針劑保存安定性 藥品應置於攝氏 2 ~ 8 度冰箱內(勿冷凍);如發生變質或過期,不可再使用。(1080426仿單資料)
最近修改日期時間
Updated
4/26/2019 5:21:10 PM
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