————美国FDA批准5合1儿童新复方疫苗Pentacel上市 美国FDA批准首个5合1儿童新复方疫苗Pentacel上市，用于婴儿和出生6周～4岁儿童对白喉、破伤风、百日咳、脊髓灰质炎及Hib流感的免疫。本品由赛诺菲·安万特集团（sanofi-aventis Group）疫苗子公司赛诺菲巴斯德公司（Sanofi Pasteur）开发，以白喉、破伤风类毒素、吸附的无细胞百日咳、灭活的脊髓灰质炎和与破伤风类毒素结合的Hib流感病毒制成的疫苗。 本品获准采用4剂给药方案：在出生后2、4、6和15～18月各1次。按照目前美国疾病预防和控制中心推荐的儿童免疫方案，出生后18个月使用单种疫苗需注射多达23次。本品通过减少注射次数简化免疫给药方案。 美国FDA批准本品上市基于在美国和加拿大纳入5 000多例儿童、每个儿童至少注射1剂Pentacel疫苗的多中心临床研究结果。本品的免疫性和安全性可与分别接种5种相应的单一疫苗相媲美。 在临床研究中，注射本品后报告的局部和全身性不良反应很少，与分别注射单一疫苗相近。本品最常见的不良反应是注射部位红肿和触痛，发热，激动和哭叫。 Pentacel Generic Name: diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine Dosage Form: injection ----------------------------------------------------------------------------- Pentacel® contains lyophilized ActHIB that is reconstituted with a liquid DTaP/IPV solution. Pentacel® is approved by FDA for doses 1 through 4 of the DTaP and IPV series among children 6 weeks through 4 years of age. Pentacel® should not be used for the fifth dose of the DTaP series and is not indicated for children 5 years or older. ------------------------------------------------------------------------------- Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday). Safety Information The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination. The decision to give Pentacel vaccine should be based on the potential benefits and risks; if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel vaccine may not protect all individuals. Before administering Pentacel vaccine, please see the full Prescribing Information. Pentacel vaccine is manufactured by Sanofi Pasteur Limited and Sanofi Pasteur SA and distributed by Sanofi Pasteur Inc. a DTaP = Diphtheria, tetanus, and acellular pertussis; IPV = Inactivated poliovirus.  b Hib = Haemophilus influenzae type b.  c DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).  d PT = Pertussis toxin detoxified.  e FHA = Filamentous hemagglutinin.  f ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]).  g IPOL (Poliovirus Vaccine Inactivated).