ActHIB是赛诺菲巴斯德，领先的疫苗生产商在世界之一，具有可用于医疗实践的ActHIB疫苗
ActHIB是早期儿童疫苗提供，防止因细菌特定疾病的保护。它可以与另一种疫苗，以防止更多的条件下，如白喉和破伤风组合。
疫苗是最初在冷冻干燥状态并与注射生理盐水给药。常见反应包括发热和发红或在注射部位肿胀。
批准日期：2016年4月 公司：赛诺菲巴斯德
ActHIB®嗜血杆菌b结合物疫苗（破伤风类毒素结合）的解决方案肌内注射
最初美国批准：1993年
目前的主要变化
警告和注意事项，乳胶 [3/2016]
作用机理
流感嗜血杆菌（流感嗜血杆菌）是一种革兰氏阴性球杆菌。引起侵袭性疾病（例如，败血症和脑膜炎）流感嗜血杆菌的大多数菌株是流感嗜血杆菌b型。
到ActHIB疫苗的反应是典型的抗原依赖的T-免疫应答。通过ActHIB疫苗诱导的抗荚膜PRP抗体的突出的同种型为IgG。 抗体进行加强免疫反应已被证明在儿童12月龄以上的老年人谁以前收到的两个或三个剂量ActHIB疫苗。针对B型流感的杀菌活性在免疫后血清证实，并与由ActHIB疫苗诱导的抗-PRP抗体应答相关。
抗体滴度与比24月龄年龄较大的儿童侵袭性B型流感病长期保护相关的未结合疫苗PRP> 1.0微克/毫升以下接种流感嗜血荚膜多糖（抗PRP）。虽然这个阈临床保护与结合疫苗免疫后的相关性是未知的，尤其是在诱导免疫记忆的光，这种程度仍然被视为指示长期的保护。 在临床研究中，ActHIB疫苗诱导，平均而言，抗-PRP水平≥1.0微克/毫升的婴儿为90％的主要系列后（2，4和6个月）和婴幼儿的98％以上的以下一个助推器剂量在15至19个月的年龄给出。
适应症和用法
ActHIB是用于预防由流感嗜血杆菌b型浸润性疾病的指示的疫苗。ActHIB疫苗是通过5岁批准用作婴儿和儿童2个月4剂量系列。
用法用量
四个剂量系列（各0.5毫升）通过肌内注射：
一个三剂主要扳成2，4和6月龄管理。
单剂量的助推器在15-18个月的年龄给予。
剂型和规格
解决方案注射：冻干粉中提供的0.4％氯化钠稀释剂重建。单剂量，配制后是0.5毫升
禁忌症
任何流感嗜血杆菌b型或破伤风类毒素含有疫苗或ActHIB疫苗的任何组分的先前剂量后严重的过敏反应（例如，过敏性反应）。
警告和注意事项
如果吉兰 - 巴雷综合征6周收到包含破伤风类毒素事先接种疫苗后内发生的潜在利益和给予ActHIB疫苗的风险必须进行评估。
不良反应
继儿童2-20个月的婴儿，由剂量数和收件人的年龄而异的不良反应发生率ActHIB疫苗的管理：
在孩子15-20月龄压痛（20％）的是以下的单剂量最常用的局部反应。
任何剂量为儿童2个月至16个月年龄后最常见的全身性反应为烦躁/易怒（75％），伤心哭泣（58％）和活性下降/嗜睡（51％）。
包装规格
ACTHIB SNGL ENTY VACC CON 5  HAEMOPH B POLY CONJ-TET TOX/PF     49281-0545-05     
ACTHIB W/DILUENT SDV 5DOSE 5/EA  HAEMOPH B POLYSAC CONJ-TET TOX     49281-0545-05
ACTHIB SNGL ENTY VACC CON 5  HAEMOPH B POLY CONJ-TET TOX/PF     49281-0545-03 

原研药品的完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8143d01c-4911-40db-95b2-47f3ebea2a7d

ActHIB (haemophilus b conjugate vaccine (tetanus toxoid conjugate)) - Drug SummarySanofi Pasteur Inc.
ActHIB
(haemophilus b conjugate vaccine (tetanus toxoid conjugate))
THERAPEUTIC CLASS
Vaccine
DEA CLASS
RX
PEDIATRIC DOSAGE & INDICATIONS
Haemophilus influenza Type B
Prevention of Invasive Disease:
2 Months-5 Years:
0.5mL IM single dose
Administer as a 4-dose series; series consists of a primary 3-dose series of a single dose at 2, 4, and 6 months of age, followed by 1 booster dose at 15-18 months of age
ADMINISTRATION
IM route
Administer into the anterolateral aspect of the thigh or deltoid.
Do not mix in the same syringe w/ other parenteral products.
Reconstitution
- Reconstitute only w/ accompanying saline diluent.
- Withdraw 0.6mL of saline diluent from accompanying vial.
- Transfer 0.6mL saline diluent into lyophilized vaccine vial; agitate the vial thoroughly.
- Withdraw 0.5mL of reconstituted vaccine and administer.
Administer promptly after reconstitution or store at 2-8°C (35-46°F) and administer w/in 24 hrs; re-agitate stored vaccine before administration.
HOW SUPPLIED
Inj: 0.5mL
CONTRAINDICATIONS
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine.
WARNINGS/PRECAUTIONS
Epinephrine and other appropriate agents must be available if an acute anaphylactic reaction occurs. Evaluate potential benefits and risks if Guillain-Barre syndrome has occurred w/in 6 weeks of receipt of a prior tetanus toxoid-containing vaccine. Expected antibody responses may not be obtained if administered to immunosuppressed persons. May not protect all individuals. Does not substitute for routine tetanus immunization.
ADVERSE REACTIONS
Tenderness, fussiness/irritability, inconsolable crying, decreased activity/lethargy.
DRUG INTERACTIONS
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce immune response to vaccine.
PREGNANCY AND LACTATION
Pregnancy: Category C.
Lactation: Safety not known in nursing.
MECHANISM OF ACTION
Vaccine; produces antibody response to protect against H. influenzae type b.
ASSESSMENT
Assess for history of a severe allergic reaction to previous dose of any H. influenzae type b vaccination, tetanus toxoid-containing vaccine, or any component of the vaccine; history of Guillain-Barre syndrome w/in 6 weeks of receipt of a prior vaccine containing tetanus toxoid; immunosuppression; and for possible drug interactions. Review immunization history.
MONITORING
Monitor for allergic reactions, signs/symptoms of Guillain-Barre syndrome, inj-site reactions, and for any other possible adverse events. Monitor immune response.
PATIENT COUNSELING
Inform parents/guardians of the benefits and risks of vaccination, and of the importance of completing the immunization series. Instruct parents/guardians to report any serious adverse reactions to physician.
STORAGE
Lyophilized Vaccine Vial/After Reconstitution: 2-8°C (35-46°F). Do not freeze lyophilized vaccine.