藥品名稱
drug name | DTaP, IPV, Haemophilus influenzae type B, hepatitis B conjugate vaccine 0.5mL/syringe(Hexaxim ,公費六合一 |
| 藥檔狀態 | |
成 份
Ingredient | Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type B, hepatitis B conjugate vaccine |
| 單位含量 | 0.5mL/syringe |
| Dosage Forms | Injection, suspension: 0.5mL/syringe |
| 外觀描述 | 針劑/針筒 |
| Appearance | injection/syringe |
廠商名稱
Manufacturer | Sanofi Pasteur SA |
製 造 商
Manufacturer | Sanofi Pasteur SA |
字 號
Product ID | 專案進口,無藥字號 |
藥理分類
Pharmacologic Category | Vaccine, Inactivated (Bacterial, Viral) |
作用機轉
Mechanism of action | Promotes active immunity to diphtheria, tetanus, pertussis, hepatitis B, poliovirus (types 1, 2, and 3), and Haemophilus influenzaetype B by inducing production of specific antibodies and antitoxins. |
| 用途/適應症 | 六合一疫苗 |
| Use |
Active primary immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b in infants and children 6 weeks to 2 years of age; booster immunization (at 18 months) in infants who previously received a full primary vaccination course of each component of the vaccine
|
衛福部核准適用症狀
MOHW approved indications |
專案進口，用於預防白喉、破傷風、百日咳、小兒麻痺、b型嗜血桿菌與B型肝炎感染。
|
| 常用劑量 | 每天一次，早飯後使用0.5mL
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
Dosing: Pediatric
Note: Vaccinate preterm infants according to their chronological age from birth. Children 6 weeks to 2 years:
Primary immunization: IM: 0.5 mL; repeat in 8-week intervals for a total of 3 doses. Vaccination usually begins at 2 months, but may be started at 6 weeks of age. Do not administer to infants <6 weeks of age.
Use in children previously vaccinated with one or more doses of hepatitis B vaccine: Children who received 1 dose of hepatitis B vaccine at birth may receive a 3 dose series of Infanrix Hexa™ beginning no earlier than at 6 weeks of age. Use in infants who received more than 1 dose of hepatitis B vaccine has not been studied.
Where immunization against poliovirus is desired, Infanrix Hexa™ may be administered instead to infants scheduled to receive concurrent Infanrix™ (diphtheria, tetanus and acellular pertussis vaccine) and hepatitis B vaccine.
Booster immunization: IM: 0.5 mL administered at 18 months (in infants who have received a full primary vaccination course of each component of Infanrix Hexa™)
Note: Dosing delays should not interfere with the final immunity achieved with Infanrix Hexa™. Regardless of the time that elapses between doses, it is not necessary to restart the vaccination series.
|
懷孕分級
Pregnancy Risk Factor |
Not indicated for use in pregnant women.
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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。]
|
| 禁忌症 |
1.對本藥或其中的任何成分過敏者;或對製程中使用的物質如:glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B過敏
2.曾施打過Hexaxim疫苗或任何含本藥活性成分的疫苗有過敏者
3.使用含百日咳疫苗接種後，7天內發生未知病因的腦病變
4.如有未控制或重度的腦部或神經疾病
5.未受控制的癲癇
|
| Contraindications |
Hypersensitivity to any component of vaccine or formulation; encephalopathy of unknown etiology within 1 week following prior vaccination with a pertussis-containing vaccine; moderate or severe acute febrile illness or acute infection; children >7 years of age
|
| 常見副作用 | 可能發生：躁動、嗜睡、食慾不振、注射部位紅斑或疼痛、發燒 |
| Common adverse drug reactions | Irritability, hypersomnia, anorexia, erythema or pain at injection site and fever. |
| Adverse Reactions |
>10%:
Central nervous system: Irritability (83%), hypersomnia (63%), sleep disorder (sleeping decreased: 51%), emotional lability (crying: 43%), fatigue, restlessness
Gastrointestinal: Anorexia (49%), diarrhea (36%), vomiting (25%)
Local: Erythema at injection site (49%), pain at injection site (43%), swelling at injection site (36%)
Miscellaneous: Fever (≥38°C [100.4°F]: 56%; >39.5°C [103.1°F]*)
1% to 10%:
Central nervous system: Nervousness
Local: Induration at injection site
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★高警訊藥品
監測建議 |
|
監測
Monitoring |
Signs/symptoms of hypersensitivity for 30 minutes after administration; respiratory function for 2-3 days following vaccination of infants born prematurely. 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 | 冷藏，儲存避光，肌肉注射。 |
| Warnings & precautions | 冷藏，儲存避光，肌肉注射。 |
| 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。不可注射到血管內或皮下注射。(1060427仿單資料)
|
| 針劑保存安定性 |
2-8度C儲存，放置原包裝中以避光。不可冷凍。(1060427仿單資料)
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最近修改日期時間
Updated | 5/1/2017 10:22:37 AM |