藥品名稱
drug name | Infanrix-IPV + HIB 0.5 ml/vial 嬰護寧五合一疫苗(白喉\破傷風\無細胞性百日咳\去活性小兒麻痹\b型流行性感冒嗜血桿菌混合疫苗)【公費】 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | pertussis toxoid, diphtheria toxoid, tetanus toxoid, inactivated polio virus -type 1, inactivated polio virus - type 2, inactivated polio virus -type 3, conjugated of haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid (t), |
| 單位含量 | 0.5 ml/dose/vial |
| Dosage Forms | Injection: 0.5 ml [A 0.5 ml dose contains: diphtheria toxoid not less than 30 IU, tetanus toxoid not less than 40 IU, pertusis toxoid 25 mcg, filamentous haemagglutinin (FHA) 25 mcg, pertactin 8 mcg, Polio virus type 1 (Mahoney) 40 D antigen units, type 2 |
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大 小
Size | |
標 示
outward | |
廠商名稱
Manufacturer | 荷商葛蘭素史克藥廠股份有限公司台灣分公司 |
製 造 商
Manufacturer | GLAXOSMITHKLINE BIOLOGICALS S.A. |
字 號
Product ID | 衛署菌疫輸字第000702號 |
藥理分類
Pharmacologic Category | Vaccine, Inactivated (Bacterial)/Vaccine, Inactivated (Viral) |
作用機轉
Mechanism of action | Promotes active immunity to diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenza type b by inducing production of specific antibodies and antitoxins. |
| 用途/適應症 | 五合一疫苗 |
| Use |
針對二個月以上嬰幼兒白喉、百日咳、破傷風、小兒麻痺及B型流行性感冒嗜血桿菌之主動免疫。
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衛福部核准適用症狀
MOHW approved indications |
針對二個月以上嬰幼兒白喉、百日咳、破傷風、小兒麻痺及B型流行性感冒嗜血桿菌之主動免疫。
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| 常用劑量 | 立刻使用1vial
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
IM: 0.5 ml of vaccine. The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 2 months. An interval of at least 1 month should be maintained between subsequent doses. A booster dose is recommended in the second year of life.
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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 |
Infanrix-IPV+Hib不可用於已知對此疫苗中之任何成分過敏者，或先前曾於接種白喉/破傷風/百日咳疫苗、去活性小兒麻痺疫苗或Hib疫苗之後出現過敏現象者。
先前曾於接種含有百日咳成分之疫苗後的7天內發生病因不明之腦病變的兒童應禁用Infanrix-IPV+Hib。
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| Contraindications |
Severe allergic reaction to any vaccine containing diphtheria toxoid, tetanus toxoid, pertussis, poliovirus, or Haemophilus b, or any component of this vaccine; encephalopathy occurring within 7 days of a previous pertussis vaccine not (not attributable to another identifiable cause); progressive neurologic disorders (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy).
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
>10%:
Central nervous system: Fussiness/irritability (54% to 77%; >3 hours 4% to 5%), inconsolable crying (36% to 60%; >3 hours ¯2%), lethargy/decreased activity (24% to 46%; severe ¯3%), fever ￣38足C (6% to 16%)
Local: Injection site reactions: Tenderness (39% to 56%; severe 1% to 5%), arm circumference increase >5 mm (34%; >40 mm <1%), redness >5 mm (7% to 17%)
1% to 10%: Local: Injection site reaction: Swelling >5 mm (5% to 10%)
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監測
Monitoring |
Periodic renal function tests, urinalysis, serum vancomycin concentrations, WBC, audiogram
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| 警語與注意事項 | 請遵照醫師或藥師指示使用；不可口服。 |
| 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 |
肌肉注射。
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| 針劑保存安定性 |
2-8℃ 冷藏避光儲存。
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最近修改日期時間
Updated | 9/15/2022 9:52:18 AM |