藥品名稱
drug name | 公費 五合一疫苗 INFANRIX-IPV + HIB/ Pediacel TM(舊名), 嬰護寧五合一疫苗 (白喉、百日咳、破傷風、小兒麻痺及b型流行性感冒嗜血桿菌疫苗) 0.5 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Diphtheria, Tetanus Toxoids, Acellular Pertussis, Poliovirus, and Haemophilus b conjugate vaccine |
| 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 |
| 外觀描述 | 針劑/小瓶 |
| Appearance | injection/vial |
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.,BELGIUM |
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 |
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by H. influenzae type b in children 6 weeks through 4 years of age.
|
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。
|
| Dose |
Deep IM.
Primary immunization: 0.5 mL/dose×3 doses usually at 2, 4, and 6 months old; and booster dose given 1yr after 3rd dose.
|
懷孕分級
Pregnancy Risk Factor |
C
|
| 禁忌症 |
1. 若已知對本疫苗之任何成份產生過敏反應，或先前使用本疫苗（或使用和本疫苗有一或多種相同成份之疫苗）後出現危及生命的反應，則禁止使用本疫苗。
2. 進展中的腦病變
3. 七天內因接種百日咳疫苗(非細胞或全細胞)引發腦病變者
4. 發燒或罹患急性疾病(疫苗接種必須延後)
|
| Contraindications |
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)
|
| 常見副作用 | 注射部位紅腫疼痛、輕微發燒、煩躁不安、倦怠、食慾降低，通常2-3天後會恢復。 |
| Common adverse drug reactions | Injection site pain and swelling, mild fever, agitation, fatigue and loss of appetite.Will be restored usually in 2-3 days. |
| Adverse Reactions |
>10%:
Central nervous system: Irritability (≦54% to 77%; >3 hours: ≦4% to 5%), uncontrolled crying (36% to 60%; >3 hours: ≦2%), lethargy (≦24% to 46%; severe: ≦3%), hypoactivity (≦24% to 46%; severe: ≦3%)
Endocrine & metabolic: Increased arm circumference (>5 mm: 34%; >40 mm: <1%)
Local: Tenderness at injection site (39% to 56%; severe: 1% to 5%), erythema at injection site (>5 mm: 7% to 17%)
Miscellaneous: Fussiness (≦54% to 77%; >3 hours: ≦4% to 5%), fever (≧38°C: 6% to 16%)
1% to 10%:
Local: Swelling at injection site (>5 mm: 5% to 10%)
|
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 | 請遵照醫師或藥師指示使用；不可口服.111.11.21換廠Infanrix |
| Warnings & precautions | |
| 針劑溶解條件 |
不需溶解。
|
| 針劑稀釋條件 |
不需稀釋。
|
| 針劑不相容性 |
仿單無資料。
|
| 針劑施打條件 |
肌肉注射。
|
| 針劑保存安定性 |
2-8℃ 冷藏避光儲存。
|
最近修改日期時間
Updated | 11/21/2022 5:29:22 PM |