Excipients
Thiomersal 0.065 mg
Tris
Maleic acid
Sodium chloride
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product except Innovax-ILT, Innovax-ND-IBD or Innovax-ND-ILT and the solvent supplied for use with the veterinary medicinal product.
Shelf-life
Shelf life of the cell concentrate as packed for sale: 5 years.
Shelf life after reconstitution according to directions: 2 hours.
Shelf life of the solvent (multilayer plastic bags) as packaged for sale: 3 years.
Special precautions for storage
Concentrate:
Store and transport frozen in liquid nitrogen at a temperature below ≤ -150 °C.
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
Concentrate:
1 000, 2 000, 4 000 and 5 000 dose ampoules of hydrolytic 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 multilayer plastic bag of 200 ml, 400 ml, 500 ml, 600 ml, 800 ml, 1 000 ml, 1 200 ml or 1 600 ml.
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.
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.