Calf Paratyphoid Vaccine, Living
DEFINITION
Salmonella Dublin Vaccine, Living is a suspension of a suitably modified rough strain of Salmonella Dublin. The vaccine is prepared immediately before use by reconstitution from the freeze-dried vaccine with a suitable liquid.
PRODUCTION
The vaccine may be prepared using suitable cultures grown in solid or liquid media.
Safety
Carry out a test in each category of animal for which the vaccine is to be recommended. Vaccinate at least five animals that, as far as possible, are free from antibodies to Salmonella spp. Administer to each animal a quantity of bacteria containing not less than ten times the maximum titre likely to be contained in a dose of the vaccine. Observe the animals for 2 weeks. No abnormal local or systemic reactions occur.
The reconstituted vaccine complies with the requirements stated under Veterinary Vaccines, with the following modifications.
IDENTIFICATION
Consists of a suspension of Gram-negative bacilli having the morphological, cultural and serological characteristics of rough strains of S. Dublin.
TESTS
Bacteria and fungi
Carry out the test by microscopic examination and by inoculation of suitable media, or verify the absence of micro- organisms other than the vaccine strain present in the vaccine as described in the test for sterility prescribed in the monograph Veterinary Vaccines. The vaccine complies with the test if it does not contain extraneous micro-organisms.
Viable count
The batch complies with the test if the titre of the batch is not less than the titre stated on the label, determined by plate counts.
