藥品名稱
drug name | Tetana 0.5mL/amp (Tetanus toxoid , 破傷風類毒素疫苗) |
| 藥檔狀態 | 停用 |
成 份
Ingredient | Tetanus Toxoid |
| 單位含量 | 0.5 mL/amp |
| Dosage Forms | Suspensions,injection :0.5mL |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | 國光生物科技股份有限公司 |
製 造 商
Manufacturer | IBSS BIOMED S.A. |
字 號
Product ID | 專案進口 |
藥理分類
Pharmacologic Category | Vaccine, Inactivated (Bacterial) |
作用機轉
Mechanism of action | Tetanus toxoid preparations contain the toxin produced by virulent tetanus bacilli (detoxified growth products of Clostridium tetani). The toxin has been modified by treatment with formaldehyde so that it has lost toxicity but still retains ability to act as antigen and produce active immunity; the aluminum salt, a mineral adjuvant, delays the rate of absorption and prolongs and enhances its properties; duration ~10 years. |
| 用途/適應症 | |
| Use |
Active immunization against tetanus when combination antigen preparations are not indicated; tetanus prophylaxis in wound management. Note: Tetanus and diphtheria toxoids for adult use (Td) is the preferred immunizing agent for most adults and for children after their seventh birthday. Young children should receive trivalent DTaP (diphtheria/tetanus/acellular pertussis) as part of their childhood immunization program, unless pertussis is contraindicated, then DT is warranted.
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衛福部核准適用症狀
MOHW approved indications |
預防破傷風
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| 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 |
Dosing: Adult
Note: Tetanus Toxoid (adsorbed) has been discontinued in the US for more than 1 year.
Note: In most patients, Td is the recommended product for primary immunization, booster doses, and tetanus immunization in wound management (refer to Diphtheria and Tetanus Toxoid monograph).
Primary immunization: IM: 0.5 mL; repeat 0.5 mL at 4-8 weeks after first dose and at 6-12 months after second dose
Routine booster dose: Recommended every 10 years
Tetanus prophylaxis in wound management: Tetanus prophylaxis in patients with wounds should consider if the wound is clean or contaminated, the immunization status of the patient, proper use of tetanus toxoid and/or tetanus immune globulin (TIG), wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.
Tetanus Prophylaxis in Wound Management
History of Tetanus Immunization Doses:
1. Uncertain or <3 doses:
a. Clean, Minor Wounds:
Tetanus Toxoid(2):Yes；TIG: No
b. Other Wounds(1):
Tetanus Toxoid(2):Yes；TIG: No
2. 3 or more doses
a. Clean, Minor Wounds:
Tetanus Toxoid(2): No(3)；TIG: No
b. All Other Wounds(1):
Tetanus Toxoid(2): No(4)；TIG: No
(1)Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite.
(2)Tetanus toxoid in this chart refers to a tetanus toxoid-containing vaccine. For children <7 years of age, DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≧7 years and Adults, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.
(3)Yes, if ≧10 years since last dose.
(4)Yes, if ≧5 years since last dose.
Dosing: Pediatric
Note: Tetanus Toxoid (adsorbed) has been discontinued in the US for more than 1 year.
Children ≧ 7 years: Refer to adult dosing.
Dosing: Geriatric
Refer to adult dosing.
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懷孕分級
Pregnancy Risk Factor |
C
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[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。]
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| 禁忌症 |
仿單無。對本藥成分或所含賦形劑過敏者禁用。
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| Contraindications |
Hypersensitivity to tetanus toxoid or any component of the formulation
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Frequency not defined.
Cardiovascular: Hypotension
Central nervous system: Guillain-Barre syndrome, malaise, neuritis (brachial), pain
Dermatologic: Rash at injection site, skin sclerosis (with or without tenderness), urticaria at injection site
Gastrointestinal: Nausea
Hypersensitivity: Anaphylaxis, Arthus phenomenon
Local: Erythema at injection site, swelling at injection site, warm sensation at injection site
Neuromuscular & skeletal: Arthralgia
Miscellaneous: Fever
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★高警訊藥品
監測建議 |
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監測
Monitoring |
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.
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| 警語與注意事項 | |
| Warnings & precautions | |
| 針劑溶解條件 |
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| 針劑稀釋條件 |
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| 針劑不相容性 |
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| 針劑施打條件 |
深層皮下注射，一般於高位上臂肌肉(三角肌)接受注射。本品嚴禁血管內注射。(1071224仿單資料)
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| 針劑保存安定性 |
儲存於2-8℃，嚴禁凍結，若有凍結須丟棄。避光儲存。(1071224仿單資料)
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最近修改日期時間
Updated | 7/21/2020 11:59:49 AM |