藥品名稱
drug name | Tetraxim 0.5mL/syringe (Tetanus, diphtheria, pertussis, poliomyelitis vaccine), 巴斯德四合一疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Tetanus, diphtheria, pertussis, poliomyelitis vaccine |
| 單位含量 | 0.5mL/syringe |
| Dosage Forms | Injection, suspension [preservative free]: 0.5mL/syringe |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | 賽諾菲股份有限公司 |
製 造 商
Manufacturer | SANOFI PASTEUR S.A. |
字 號
Product ID | 衛部菌疫輸字第000998號 |
藥理分類
Pharmacologic Category | Vaccine; Vaccine, Inactivated (Bacterial); Vaccine, Inactivated (Viral) |
作用機轉
Mechanism of action | Promotes active immunity to diphtheria, tetanus, pertussis, and poliovirus (types 1, 2 and 3) by inducing production of specific antibodies and antitoxins. |
| 用途/適應症 | |
| Use |
Diphtheria, tetanus, pertussis, and poliovirus disease prevention
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衛福部核准適用症狀
MOHW approved indications |
適用於出生2個月至未滿13歲孩童的主動免疫接種，以預防白喉、破傷風、百日咳及小兒麻痺。
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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 |
【Pediatric】
Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≦4 days before minimum interval or age are considered valid; however local or state mandates may supersede this timeframe (ACIP [Kroger 2021]).
仿單：
‧ 基礎接種：由2個月大開始，共接種3劑，每劑至少間隔1個月。
‧ 追加接種：基礎接種之後1年追加注射1劑，意即，通常在出生後18個月。
‧ 5~7歲之間的追加接種：1劑。
【Renal Impairment】
There are no dosage adjustments provided in the manufacturer`s labeling.
【Hepatic Impairment】
There are no dosage adjustments provided in the manufacturer`s labeling.
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懷孕分級
Pregnancy Risk Factor |
依文獻內容判定系統稽核懷孕分級建置為：C
Lexicomp:
Kinrix and Quadracel are not approved for use in patients >7 years of age.
Adacel-Polio [Canadian product] is approved for use during pregnancy to provide passive immunization against pertussis in infants. Based on available data, adverse maternal or fetal outcomes have not been observed following maternal vaccination (most exposures occurred during the third trimester). Vaccination should be done during third trimester or as recommended by the National Advisory Committee on Immunization guidelines.
仿單：無相關資料。
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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 |
1.對任何疫苗成分曾有嚴重過敏反應，包括：
‧ Tetraxim中的任何活性成分。
‧ 內含之任一賦形劑。
‧ 戊二醛（Glutaraldehyde）、新黴素（Neomycin）、鏈黴素（Streptomtycin）及多黏菌素B（Polymyxin B）（製程中使用且可能微量殘留）。
‧ 百日咳疫苗（非細胞性或全細胞性）。
2.先前接種本疫苗或與接種與本疫苗含有相同成分的疫苗曾出現危及生命反應者。
3.先前接種任何含有百日咳抗原（全細胞性或非細胞性百日咳疫苗）的疫苗後，於7天內出現沒有可辨識原因所造成的腦病變者。
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| Contraindications |
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine, or to any component of the vaccine, including neomycin and polymyxin B; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
>10%:
-Endocrine & metabolic: Hot flash (prostate cancer: 59% to 73%; central precocious puberty: 2% to 5%), increased serum glucose (prostate cancer)
-Hematologic & oncologic: Decreased hemoglobin (prostate cancer), decreased red blood cells (prostate cancer)
-Hepatic: Increased serum alanine aminotransferase (prostate cancer), increased serum aspartate aminotransferase (prostate cancer), increased serum transaminases (prostate cancer)
-Local: Pain at injection site (central precocious puberty: 45%; prostate cancer: 4%), erythema at injection site (central precocious puberty: 14%)
-Nervous system: Headache (2% to 14%)
-Neuromuscular & skeletal: Skeletal pain (prostate cancer: 12% to 13%)
-Renal: Increased blood urea nitrogen (prostate cancer)
-Respiratory: Nasopharyngitis (central precocious puberty: 14%)
1% to 10%:
-Cardiovascular: Lower extremity edema (prostate cancer: 6%), hypertension (prostate cancer:≦4%; central precocious puberty), chest pain (prostate cancer: 2%), peripheral edema (prostate cancer: 1%)
-Dermatologic: Injection site pruritus (central precocious puberty: 2%), skin rash (prostate cancer: 2%), pruritus (prostate cancer: 1%)
-Endocrine & metabolic: Decreased libido (prostate cancer: 2%), dependent edema (prostate cancer: 2%), gynecomastia (prostate cancer: 2%)
-Gastrointestinal: Gastroenteritis (central precocious puberty: 7%), nausea (prostate cancer: 3%), anorexia (prostate cancer: 2%), constipation (prostate cancer: 2%), dyspepsia (prostate cancer: 2%), vomiting (prostate cancer: 2%), abdominal pain (prostate cancer: 1%), diarrhea (prostate cancer: 1%)
-Genitourinary: Erectile dysfunction (prostate cancer: 10%), menstruation (central precocious puberty: 8%), testicular atrophy (prostate cancer: 8%), impotence (prostate cancer: 2% to 7%), dysuria (prostate cancer: 5%), mastalgia (prostate cancer: 2%), urinary retention (prostate cancer: 1%), urinary tract infection (prostate cancer: 1%)
-Hematologic & oncologic: Anemia (prostate cancer: 1%)
Hepatic: Increased serum alkaline phosphatase (≧2%), hepatic insufficiency (prostate cancer: 1%)
-Infection: Influenza (central precocious puberty: 5%)
-Local: Swelling at injection site (central precocious puberty: 2%)
-Nervous system: Pain (prostate cancer: 2% to 3%), dizziness (prostate cancer: 1% to 3%), anxiety (central precocious puberty: 2%), fatigue (prostate cancer: 2%), mood changes (central precocious puberty: 2%), insomnia (prostate cancer:≦2%), emotional lability (≦1%)
-Neuromuscular & skeletal: Lower extremity pain (prostate cancer: 2% to 5%), back pain (prostate cancer:≦3%), lower limb cramps (prostate cancer: 2%), arthralgia (prostate cancer:≦2%), asthenia (prostate cancer: 1%), myalgia (prostate cancer: 1%)
-Ophthalmic: Conjunctivitis (prostate cancer: 1%), eye pain (prostate cancer: 1%)
-Otic: Otitis externa (central precocious puberty: 5%)
-Respiratory: Upper respiratory tract infection (central precocious puberty: 9%), cough (central precocious puberty: 7%; prostate cancer: 2%), bronchitis (central precocious puberty: 5%), pharyngitis (central precocious puberty: 5%; prostate cancer: 1%), sinusitis (central precocious puberty: 5%), dyspnea (prostate cancer: 1%)
-Miscellaneous: Postoperative pain (reproductive studies: 3% to 4%), missed abortion (reproductive studies: 2%)
-Frequency not defined: Endocrine & metabolic: Increased testosterone level
<1%,
postmarketing, and/or case reports: Altered gonadal hormone levels (pituitary-gonadal axis suppression), anaphylactic shock, anaphylactoid shock, angioedema, cerebrovascular accident, deep vein thrombosis, hypersensitivity reaction, interstitial pulmonary disease, intracranial hypertension (Tan 2019), limb pain, myocardial infarction, pituitary apoplexy, pulmonary embolism, seizure, thrombophlebitis, transient ischemic attacks, urticaria, visual disturbance, visual impairment
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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 (ACIP [Kroger 2021]). 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 |
本疫苗可以與b型嗜血桿菌接合疫苗(Act-HIB)混合後一起使用。除外不得與其他藥物混合使用。(1100524仿單資料)
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| 針劑施打條件 |
以肌肉注射方式接種。最好注射在未滿2歲嬰幼兒的大腿前外側（中間三分之一範圍）及滿2歲兒童的上臂三角肌。(1100524仿單資料)
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| 針劑保存安定性 |
儲存於冰箱(2- 8℃)。不可冷凍。(1100524仿單資料)
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最近修改日期時間
Updated | 6/21/2021 10:19:51 AM |
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現用藥品
Available
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停用藥品
Old item
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藥品仿單
DrugLabeling
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