Rubella Virus Vaccine Live
» Rubella Virus Vaccine Live conforms to the regulations of the FDA concerning biologics (630.60 to 630.67) (see Biologics 1041). It is a bacterially sterile preparation of live virus derived from a strain of rubella virus that has been tested for neurovirulence in monkeys, and for immunogenicity, that is free from all demonstrable viable microbial agents except unavoidable bacteriophage, and that has been found suitable for human immunization. The strain is grown, for purposes of vaccine production, on primary cell cultures of duck embryo tissue, derived from pathogen-free flocks, or on primary cell cultures of a designated strain of human tissue, provided that the same cell culture system is used as that in which the strain was tested. The strain meets the requirements of the specific safety tests in adult and suckling mice; and the requirements of the tests in monkey kidney, chicken embryo, and human tissue cell cultures and embryonated eggs. In the case of virus grown in duck embryo cell cultures, the strain meets the requirements of the test by inoculation of embryonated duck eggs, and of the tests for absence of Mycobacterium tuberculosis and of avian leucosis. In the case of virus grown in rabbit kidney cell cultures, the strain meets the requirements of the tests by inoculation of rabbits and guinea pigs, and of the tests for absence of Mycobacterium tuberculosis and of known adventitious agents of rabbits. In the case of virus grown in human tissue cell cultures, the strain meets the requirements of the specific safety tests and tests for absence of Mycobacterium tuberculosis or other adventitious agents tests by inoculation of rabbits and guinea pigs and the requirements for karyology and of the tests for absence of adventitious and other infective agents, including hemadsorption viruses and Mycoplasma, in human diploid cell cultures. 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 1000 TCID50 (quantity of virus estimated to infect 50 percent of inoculated cultures × 1000) when tested in parallel with the U.S. Reference Rubella Virus, Live.
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.