MMWR Morb Mortal Wkly Rep. 2011 Oct 21;60(41):1427.
The Food and Drug Administration (FDA) has approved revised prescribing information and patient labeling from GlaxoSmithKline Biologicals for the monovalent rotavirus vaccine (RV1, marketed as Rotarix) and revised prescribing information and patient labeling from Merck & Co. for the pentavalent rotavirus vaccine (RV5, marketed as RotaTeq) to include history of intussusception as a contraindication. FDA approved the revisions for RV1 in February 2011 and for RV5 in July 2011. In its rotavirus vaccination recommendations, CDC is updating the contraindications for rotavirus vaccine (RV1 and RV5) to include history of intussusception. Previously, CDC had considered history of intussusception a precaution but not a contraindication.
美国食品和药物管理局(FDA)已批准葛兰素史克生物制品公司修订的单价轮状病毒疫苗(RV1,商品名为 Rotarix)和默克公司修订的五价轮状病毒疫苗(RV5,商品名为 RotaTeq)的处方信息和患者标签,将肠套叠病史作为禁忌症纳入其中。FDA 于 2011 年 2 月批准了 RV1 的修订版,于 2011 年 7 月批准了 RV5 的修订版。在其轮状病毒疫苗接种建议中,CDC 更新了轮状病毒疫苗(RV1 和 RV5)的禁忌症,将肠套叠病史纳入其中。此前,CDC 将肠套叠病史视为一种预防措施,但不是禁忌症。