藥品名稱
drug name | Tetanus Toxoid (Tetanus Toxoid Alum Precipitated Injection, 明礬沈澱破傷風類毒素) 1 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Tetanus Toxoid Adsorbed |
| 單位含量 | 10 Lf/mL, 1 mL/vial |
| Dosage Forms | Injection, suspension: 10 Lf units/1 mL (1 mL) [contains aluminum and thimerosal] |
| 外觀描述 | 針劑/注射 |
| Appearance | injection/vial |
標 示
outward | 藍色瓶蓋 |
廠商名稱
Manufacturer | 國光生物科技股份有限公司 |
製 造 商
Manufacturer | 聯亞藥業股份有限公司新竹廠, TAIWAN |
字 號
Product ID | 衛署菌疫製字第000089號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Toxoid |
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.
|
衛福部核准適用症狀
MOHW approved indications |
預防破傷風。
|
| Dose |
Children > 6 months and Adults: IM, 0.5 mL/dose.
Primary immunization: 3 doses, the 2nd dose is given 4-8 wk after the 1st dose, the 3rd dose is given 6-12 mo after the 2nd dose.
Booster dose: Once every 10 years or at the time of injury or exposure when history of immunization is < 3 doses.
|
懷孕分級
Pregnancy Risk Factor |
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。
Lactation: No human data/ probably compatible
|
| 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 |
Acute febrile illness; acute infection; acute tetanus infection; defer during a poliomyelitis outbreak.
|
| 常見副作用 | 注射部位紅腫、疼痛；關節痛、發燒、噁心。 |
| Common adverse drug reactions | Injection site inflamed, pain, joint pain, fever, nausea. |
| 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.
|
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.
|
| 警語與注意事項 | 開封後請於當日使用完。 |
| Warnings & precautions | 開封後請於當日使用完。 |
| 針劑溶解條件 |
仿單無提及。(1071128仿單資料)
|
| 針劑稀釋條件 |
仿單無提及。(1071128仿單資料)
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| 針劑不相容性 |
仿單無提及。(1071128仿單資料)
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| 針劑施打條件 |
肌肉或皮下注射。(1071128仿單資料)
|
| 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。(1071128仿單資料)
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最近修改日期時間
Updated | 11/28/2018 10:40:03 AM |