白喉和破伤风类毒素及无细胞百日咳吸附、灭活脊髓灰质炎病毒和B型流感嗜血杆菌结合疫苗的许可及婴幼儿使用指南。
Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, and haemophilus B conjugate vaccine and guidance for use in infants and children.
出版信息
MMWR Morb Mortal Wkly Rep. 2008 Oct 3;57(39):1079-80.
On June 20, 2008 the Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus vaccine (IPV), and Haemophilus influenzae type b conjugate (tetanus toxoid [TT] conjugate) vaccine, DTaP-IPV/Hib (Pentacel, Sanofi Pasteur, Swiftwater, Pennsylvania), for use as a four-dose series in infants and children at ages 2, 4, 6, and 15-18 months. This report summarizes the indications for Pentacel and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.
2008年6月20日，美国食品药品监督管理局（FDA）批准了白喉和破伤风类毒素及无细胞百日咳吸附疫苗（DTaP）、灭活脊髓灰质炎病毒疫苗（IPV）和b型流感嗜血杆菌结合（破伤风类毒素[TT]结合）疫苗DTaP-IPV/Hib（Pentacel，赛诺菲巴斯德公司，宾夕法尼亚州斯威夫特沃特），用于2、4、6和15 - 18月龄婴幼儿的四剂次接种程序。本报告总结了Pentacel的适应证，并提供了免疫实践咨询委员会（ACIP）关于其使用的指导意见。
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