List of excipients
Concentrate:
Dimethyl sulfoxide
Dilution medium.
Solvent:
Sucrose
Casein hydrolysate
Phenol red 1% solution
Salts.
Major incompatibilities
Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product and except those mentioned in section "Clinical particulars"
Shelf life
Shelf life of the non-reconstituted vaccine: 3 years at -196 °C.
Shelf life after reconstitution according to instructions: up to 2 hours at a temperature below 25° C.
Shelf life of the solvent in polypropylene bottles as packaged for sale: 1 year at a temperature below 30° C.
Shelf life of the solvent in polyvinylchloride bags as packaged for sale: 2 years at a temperature below 30°C.
Special precautions for storage
Store the vaccine in liquid nitrogen.
Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.
Store the reconstituted vaccine at a temperature below 25 °C.
Do not re-use opened containers of diluted vaccine.
Store the solvent below 30 °C. Do not freeze. Protect from light.
Nature and composition of immediate packaging
Concentrate
•(glass) ampoule of 1,000 doses of vaccine (5-ampoule carrier).
•(glass) ampoule of 2,000 doses of vaccine (4-ampoule carrier).
Ampoule carriers are stored in canisters, and liquid nitrogen containers.
Solvent
•(polypropylene) bottle of 200 ml of diluent
•(polyvinylchloride) bag of 200 ml, 400 ml, 600 ml, 800 ml, 1000 ml, 1200 ml, 1400 ml, 1600 ml, 1800 ml or 2400 ml of diluent.
Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.