藥品名稱
drug name
公費 五合一疫苗 Pediacel TM/ Pentaxim(舊名) ((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 FormsInjection: 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
Appearanceinjection/vial
標  示
outward
廠商名稱
Manufacturer
賽諾菲股份有限公司
製 造 商
Manufacturer
SANOFI PASTEUR LIMITED, CANADA
字  號
Product ID
衛署菌疫輸字第000821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
可使出生後二個月至七歲的孩童對白喉、破傷風、百日咳、小兒麻痺症及侵襲性b型流行性感冒嗜血桿菌感染症產生免疫力。
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 reactionsInjection 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.105.1.21換廠Pediacel
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
4/29/2019 5:25:37 PM
花蓮
現用藥品
現用藥品 Available

停用藥品
停用藥品 Old item

View 藥品仿單
藥品仿單 DrugLabeling

View 衛福部仿單連結
衛福部仿單連結 DrugLabelingURL


二維條碼 QR code