藥品名稱
drug name | Tetanus Toxoid 1 mL/vial (明礬沉澱破傷風類毒素) |
| 藥檔狀態 | |
成 份
Ingredient | Tetanus Toxoid |
| 單位含量 | 10Lf/ml, 1ml/vial |
| Dosage Forms | Injection, suspension: 10 Lf units/1 mL (1 mL) [contains aluminum and thimerosal] |
| 外觀描述 | 針劑/小瓶 |
| Appearance | injection/vial |
廠商名稱
Manufacturer | 國光生物科技股份有限公司 |
製 造 商
Manufacturer | 國光生物科技股份有限公司 |
字 號
Product ID | 衛署菌疫製字第000089號 |
藥理分類
Pharmacologic Category | Biologic and immunologic agents/Toxoids/ |
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; duraction 10 years. |
| 用途/適應症 | 破傷風類毒素疫苗 |
| 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
|
| 常用劑量 | 立刻使用0.5mL
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
Adult : 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: I.M.: 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.
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懷孕分級
Pregnancy Risk Factor |
XM，FDA：C。仿單說明:如認為被接種者有感染破傷風之危險，而且由於接種本疫苗認為並無產生顯著障礙時，即不在此限。
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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。]
|
| 禁忌症 |
1.有發燒，或有顯著營養障礙者。
2.罹患有心臟血管系統疾病、腎臟疾病、糖尿病或腳氣病者，當該疾病在急性期或增惡期及活動期中者。
3.為本劑之成分所引起過敏者。
4.為接種本劑，曾有呈顯著異常副作用反應者。
5.在接種前一年以內，曾發生痙攣者。
6.妊產婦。
7.除上所記載外，不適宜預防接種狀態者。
|
| Contraindications |
Hypersensitivity to tetanus toxoid or any component of the formulation.
|
| 常見副作用 | 可能發生：注射部位疼痛、噁心、關節痛、發燒、身體不適。 |
| Common adverse drug reactions | Injection site pain, nausea, arthralgia, fever and malaise. |
| Adverse Reactions |
Frequency not defined.
Cardiovascular: Hypotension
Central nervous system: Brachial neuritis, fever, malaise, pain
Gastrointestinal: Nausea
Local: Edema, induration (with or without tenderness), rash, redness, urticaria, warmth
Neuromuscular: Arthralgia, Guillain-Barre syndrome
Miscellaneous: Anaphylactic reaction, Arthus-type hypersensitivity reaction.
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★高警訊藥品
監測建議 |
|
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 | 使用前請務必充分震盪，限肌肉或皮下注射。冷藏儲存避光。仿單建議孕婦不可使用。開封後，當日剩餘者需丟棄 |
| Warnings & precautions | 使用前請務必充分震盪，限肌肉或皮下注射。冷藏儲存避光。仿單建議孕婦不可使用。開封後，當日剩餘者需丟棄 |
| 針劑溶解條件 |
仿單無提及。(1020307仿單資料)
|
| 針劑稀釋條件 |
仿單無提及。(1020307仿單資料)
|
| 針劑不相容性 |
仿單無提及。(1020307仿單資料)
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| 針劑施打條件 |
限肌肉或皮下注射。(1020307仿單資料)
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| 針劑保存安定性 |
2-10度C冷暗處儲存。經插入注射針吸取疫苗的瓶中疫苗，應當日使用完畢，當日未用完者，應丟棄不用。(1020307仿單資料)
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最近修改日期時間
Updated | 1/25/2019 3:22:32 PM |