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Pharmaceutical particulars
Excipients
Vaccine:
Gelatin
Sucrose
Solvent:
Sodium chloride
di-sodium hydrogen phosphate 2H2O
Potassium di-hydrogen phosphate
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:
Vaccine: 2 years
Solvent: 3 years
Shelf life after dilution or reconstitution according to directions
Reconstituted vaccine should be used within the shortest time period necessary without exceeding a 4 hour period.
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light
Immediate packaging
Cardboard box with 1 x 5 calf doses and 1 x 10 ml solvent in glass bottles closed with a rubber stopper/aluminium combination cap.
Cardboard box with 1 x 20 calf doses and 1 x 40 ml solvent in glass bottles closed with a rubber stopper/aluminium combination cap.
For both presentations the vaccine is contained into 10 ml glass vials of Ph.Eur. Type I quality, while the solvent is contained into 10 ml (5-dose presentation) or 50 ml (20-dose presentation) glass vials of Ph.Eur. Type II quality. Both the vaccine and the solvent vials are closed with bromobutyl rubber stoppers of Ph.Eur. Type I quality.
Not all presentation may be marketed.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities