Mumps Virus Vaccine Live
» Mumps Virus Vaccine Live conforms to the regulations of the FDA concerning biologics (630.50 to 630.57) (see Biologics 1041). It is a bacterially sterile preparation of live virus derived from a strain of mumps virus tested for neurovirulence in monkeys, and for immunogenicity, free from all demonstrable viable microbial agents except unavoidable bacteriophage, and found suitable for human immunization. The strain is grown for the purpose of vaccine production on chicken embryo primary cell tissue cultures derived from pathogen-free flocks, meets the requirements of the specific safety tests in adult and suckling mice; the requirements of the tests in monkey kidney, chicken embryo and human tissue cell cultures and embryonated eggs; and the requirements of the tests for absence of Mycobacterium tuberculosis and of avian leucosis, unless the production cultures were derived from certified avian leucosis-free sources and the control fluids were tested for avian leucosis. The strain cultures are treated to remove all intact tissue cells. The Vaccine meets the requirements of the specific tissue culture test for live virus titer, in a single immunizing dose, of not less than the equivalent of 5000 TCID50 (quantity of virus estimated to infect 50% of inoculated cultures × 5000) when tested in parallel with the U.S. Reference Mumps Virus, Live. It may contain suitable antimicrobial agents.
Packaging and storage Preserve in single-dose containers, or in light-resistant, multiple-dose containers, at a temperature between 2 and 8. Multiple-dose containers for 50 doses are adapted for use only in jet injectors, and those for 10 doses for use by jet or syringe injection.
Expiration date The expiration date is 1 to 2 years, depending on the manufacturer's data, after date of issue from manufacturer's cold storage (20, 1 year).
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 8 hours.