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U.S. Department of Health and Human Services

Safety

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Remicade (Infliximab) Lyophilized Concentrate for Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2013

Summary View

WARNINGS AND PRECAUTIONS

Live Vaccine/Therapeutic Infectious Agents
  • In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines…