Influenza Virus Vaccine
»Influenza Virus Vaccine conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile,aqueous suspension of suitably inactivated influenza virus types Aand B,either individually or combined,or virus sub-units prepared from the extra-embryonic fluid of influenza virus-infected chicken embryo.The strains of influenza virus used in the preparation of this Vaccine are those designated by the U.S.Government's Expert Committee on Influenza and recommended by the Surgeon General of the U.S.Public Health Service.Influenza Virus Vaccine has a composition of such strains and a content of virus antigen of each,designated for the particular season,of not less than the specified weight (in micrograms)of influenza virus hemagglutinin determined in specific radial-immunodiffusion tests relative to the U.S.Reference Influenza Virus Vaccine.It may contain a suitable antimicrobial agent.If formalin is used for inactivation,it contains not more than 0.02percent of residual free formaldehyde.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 18months after date of issue from manufacturer's cold storage (5,1year).
Labeling— Label it to state that it is to be shaken before use and that it is not to be frozen.Label it also to state that it was prepared in embryonated chicken eggs.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 1019
Phone Number:1-301-816-8397