Measles,Mumps,and Rubella Virus Vaccine Live
»Measles,Mumps,and Rubella Virus Vaccine Live conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a bacterially sterile preparation of a combination of live measles virus,live mumps virus,and live rubella virus such that each component is prepared in conformity with and meets the requirements for Measles Virus Vaccine Live,for Mumps Virus Vaccine Live,and for Rubella Virus Vaccine Live,whichever is applicable.Each component provides an immunizing dose and meets the requirements of the corresponding Virus Vaccine in the total dosage prescribed in the labeling.It may contain suitable antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,or light-resistant,multiple-dose containers,at a temperature between 2and 8.Multiple-dose containers for 50doses are adapted for use only in jet injectors,and those for 10doses for use by jet or syringe injection.
Expiration date— The expiration date is 1to 2years,depending on the manufacturer's data,after date of issue from manufacturer's cold storage (-20,1year).
Labeling— Label the Vaccine in multiple-dose containers to indicate that the contents are intended solely for use by jet injector or for use by either jet or syringe injection,whichever is applicable.Label the Vaccine in single-dose containers,if such containers are not light-resistant,to state that it should be protected from sunlight.Label it also to state that constituted Vaccine should be discarded if not used within 8hours.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 1187
Phone Number:1-301-816-8397