Excipients
Cell Concentrate:
Bovine serum
Veggie medium
Dimethyl sulfoxide
Solvent:
Sucrose
Sodium Chloride
Disodium hydrogen phosphate dihydrate
Phenolsulfonphtalein (Phenol red)
Potassium dihydrogen phosphate
Water for injections
Major incompatibilities
Do not mix with other veterinary medicinal products.
Shelf-life
Vaccine
Shelf life of the cell concentrate as packed for sale: 4 years.
Shelf life after dilution or reconstitution according to directions:
2 hours when kept at +2°C to +8°C.
Solvent
Shelf life of the solvent (multilayer plastic bags) as packaged for sale: 3 years.
Special precautions for storage
Cell concentrate:
Store in liquid nitrogen at a temperature below ≤ -150ºC.
Thawed ampoules must not be refrozen.
Do not expose reconstituted vaccine to direct sunlight or heat.
Solvent:
Store below 30°C.
Container:
Store liquid nitrogen container securely in an upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room.
Immediate packaging
Cell concentrate:
1000, 2000, 4000 and 5000 dose ampoules of hydrolytical class type I (Ph.Eur) glass containing the cell suspension. The ampoules are heat sealed.
The ampoules are inserted in metal canes and shipped and stored in a liquid nitrogen container.
Solvent:
- One 200 ml multilayer plastic bag.
- One 400 ml multilayer plastic bag.
- One 500 ml multilayer plastic bag.
- One 600 ml multilayer plastic bag.
- One 800 ml multilayer plastic bag.
- One 1000 ml multilayer plastic bag.
- One 1200 ml multilayer plastic bag.
- One 1600 ml multilayer plastic bag.
Not all pack sizes may be marketed.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, approved for use by the competent authorities.