藥品名稱
drug name | Diphtheria, Tetanus Toxoids & Acellular Pertussis (Adacel TM, “巴斯德”三合一補追疫苗) 0.5 mL/dose/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Diphtheria, Tetanus Toxoids & Acellular Pertussis |
| 單位含量 | 0.5 mL/dose/vial |
| Dosage Forms | Injection: 0.5 mL [0.5 mL dose contains: Diphtheria 2 Lf units, tetanus 5 Lf units, and acellular pertussis 2.5 mcg] |
| 外觀描述 | 針劑/小瓶 |
| Appearance | injection/vial |
標 示
outward | 白色標籤，橘色蓋子 |
廠商名稱
Manufacturer | 賽諾菲股份有限公司 |
製 造 商
Manufacturer | SANOFI PASTEUR LIMITED,CANADA |
字 號
Product ID | 衛署菌疫輸字第000840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 |
Active booster immunization against diphtheria, tetanus, and pertussis in persons 10 to 64 years of age
|
衛福部核准適用症狀
MOHW approved indications |
適用於4歲(含)以上之追加疫苗接種，以預防白喉、破傷風、百日咳。
|
| Dose |
Administration Route: IM
Adults:
Booster immunization: 0.5 mL as a single dose, administered 5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine
Pediatrics:
Children ≧4 years and Adolescents: Booster immunization: 0.5 mL as a single dose, administered 5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine
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懷孕分級
Pregnancy Risk Factor |
C
Lactation: Excretion in breast milk unknown/use caution.
|
| 禁忌症 |
1.已知對 Adacel之任何成分或者先前接種含本疫苗相同物質之某疫苗後產生全身性過敏反應。
2.在施打前一劑含百日咳抗原之任合疫苗 (全細胞或非細胞型百日咳疫苗) 後7日內，發生不可將之歸因於另一可識別病因的腦病變為接種之禁忌症。
3.患者若有進行性神經疾患、未控制的癲癇或進行性腦病即不應接種百日咳疫苗。
|
| Contraindications |
progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy or progressive epilepsy (postpone until condition stabilized); encephalopathy occurring within 7 days of administration 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 reactions | injection site pain；headache, fatigue, GI discomfort |
| Adverse Reactions |
>10%:
Central nervous system: Headache (12% to 44%; grade 3/severe: 1% to 4%), fatigue (24% to 37%; grade 3/severe: 1% to 4%), chills (8% to 15%; severe <1%)
Endocrine & metabolic: Increased arm circumference (28%; >40 mm: 0.5%)
Gastrointestinal: Gastrointestinal disease (includes abdominal pain, diarrhea, nausea, and/or vomiting; 3% to 26%; grade 3/severe≦3%)
Local: Pain at injection site (22% to 78%; grade 3/severe:≦5%), erythema at injection site (11% to 25%;≧50 mm: 2% to 4%), swelling at injection site (8% to 21%;≧50 mm:≦3%)
Neuromuscular & skeletal: Myalgia (22% to 30%; severe: 1%), arthralgia (9% to 11%; severe: <1%)
1% to 10%:
Dermatologic: Skin rash (2% to 3%)
Hematologic & oncologic: Adenopathy (7%)
Miscellaneous: Fever (≧38°C [≧100.4°F]: 1% to 5%)
|
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 | 肌肉注射；三角肌為較佳的注射部位。使用前應適當搖晃藥瓶直到藥液變成均勻、混濁的懸浮液。 |
| Warnings & precautions | IM only. |
| 針劑溶解條件 |
不需溶解。(1090702仿單資料)
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| 針劑稀釋條件 |
不需稀釋。(1090702仿單資料)
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| 針劑不相容性 |
請勿將ADACEL與其他注射劑混合在同一注射器內。(1090702仿單資料)
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| 針劑施打條件 |
1.只能肌肉注射 (IM only!)，比較適當的接種部位是三角肌；不應在臀部注射，接種時請確認針頭未穿透血管。
2..不可靜脈或皮內注射。
3.使用前應適當搖晃藥瓶直到藥液變成均勻、混濁的懸浮液。(1090702仿單資料)
|
| 針劑保存安定性 |
1.藥品應置於2-8℃冷藏儲存(勿冷凍)；如發生變質或過期，不可再使用。(1090702仿單資料)
2.自批號C5654AC起外盒包裝變更(1090702公告)。
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最近修改日期時間
Updated | 1/30/2024 9:18:03 AM |