藥品名稱
drug name | Tetanus Toxoid (Bio-TT, /Adsorbed tetanus toxoid vaccine B.P. (舊名), 破傷風類毒素疫苗) 0.5 mL/amp |
| 藥檔狀態 | 停用 （需冷藏） |
成 份
Ingredient | Tetanus Toxoid Adsorbed |
| 單位含量 | 0.5 mL /amp |
| Dosage Forms | 0.5 mL/amp (含純化的破傷風類毒素 10 Lf, 磷酸鋁 1.5 mg, 硫柳汞 0.05mg) |
| 外觀描述 | 針劑/安瓿 |
| Appearance | injection/ampoule |
標 示
outward | |
廠商名稱
Manufacturer | 安特羅生物科技股份有限公司 |
製 造 商
Manufacturer | PT Bio Farma (Persero), Indonesia |
字 號
Product ID | 專案進口 |
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.
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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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| Dose |
Administration Route: IM
仿單：
預防破傷風/新生兒破傷風需施打三次接種，每次劑量0.5mL肌肉注射，第一次與第二次至少間隔4週，而第三次接種需於第二次接種6個月後進行。
為維持生育期間育齡婦女對破傷風之免疫力，建議接種5劑。第四次接種須至少於第三次接種後1年施打，第五次接種須至少於第四次接種後1年進行。
BIO-TT在懷孕期間給藥是安全的，施打時間最好於中期妊娠之後。對於以前未接種過疫苗的婦女，建議在懷孕期間接種兩劑，並至少間隔 4 週，第二劑應至少在分娩前兩週接種，以預防孕婦和新生兒破傷風。
BIO-TT當存在可能引發破傷風的風險因子情況下(如:受傷)，仍建議接種本產品。於事發一個月內至少接種兩劑以提供以前未接種過此疫苗的人基本保護力，當超過保護期限時須接種追加免疫一劑。國際接種時程表可提供更多詳細資訊。
BIO-TT可與卡介苗(BCG)、麻疹、風疹、腮腺炎、脊髓灰質炎（OPV或IPV）、B型肝炎、B型流感嗜血桿菌、黃熱病疫苗和維生素A補充劑同時接種。
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懷孕分級
Pregnancy Risk Factor |
BIO-TTR 在懷孕期間給藥是安全的，施打時間最好於中期妊娠之後
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| 禁忌症 |
1.對破傷風類毒素產生嚴重反應。
2.對破傷風或疫苗內其他成份過敏。
3.高燒或急性感染期間(破傷風除外)。可用於有輕微發熱疾病的患者，例如上呼吸道輕度感染。
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| Contraindications |
Hypersensitivity to tetanus toxoid vaccine or any component of the formulation; neurological disorder after a previous injection of vaccine
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| 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.
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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 | 肌肉注射給藥，使用前請充分搖動。開封後請於當日使用完。1120925換廠 |
| Warnings & precautions | 肌肉注射給藥，使用前請充分搖動。開封後請於當日使用完。 |
| 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 |
1.應以肌肉注射方式施打
2.疫苗應在使用前充分搖動，並只能使用無菌針頭和注射器施打疫苗。
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| 針劑保存安定性 |
應避光儲存於2-8℃乾燥的環境，運輸過程也應保持在2-8℃。禁止冷凍保存。
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最近修改日期時間
Updated | 9/25/2023 10:01:12 AM |