6.1 List of excipients
Lyophilisate:
Glycine
L-histidine
Sucrose
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Potassium chloride
Sodium chloride
HIPRAHATCH solvent, for poultry vaccines:
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Potassium chloride
Sodium chloride
Water for injections
Revised: May 2024
AN: 02680/2023
Page 8 of 9
6.2 Major Incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product or EVANOVO.
6.3 Shelf life
Shelf life of the lyophilisate as packaged for sale: 24 months.
Shelf life of the HIPRAHATCH solvent as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 2 hours.
Shelf life after mixing with EVANOVO: 2 hours.
6.4 Special precautions for storage
Lyophilisate:
Store and transport refrigerated (2 ºC – 8 ºC).
Do not freeze.
Protect from light.
HIPRAHATCH solvent, for poultry vaccines:
Do not store above 25 ºC.
6.5 Nature and composition of immediate packaging
Lyophilisate:
Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing 1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses, 5,000 doses, 8,000 doses or 10,000 doses of the freeze-dried vaccine.
HIPRAHATCH solvent, for poultry vaccines:
Polypropylene bags containing 200 ml, 400 ml, 500 ml, 800 ml or 1,000 ml.
Package sizes:
In ovo and subcutaneous use:
Cardboard box with 10 lyophilisate vials containing 1,000 doses.
Cardboard box with 10 lyophilisate vials containing 2,000 doses.
Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Cardboard box with 10 lyophilisate vials containing 4,000 doses.
Cardboard box with 10 lyophilisate vials containing 5,000 doses.
In ovo use only:
Cardboard box with 10 lyophilisate vials containing 8,000 doses.
Cardboard box with 10 lyophilisate vials containing 10,000 doses.
Cardboard box with 10 bags containing 200 ml HIPRAHATCH solvent.
Cardboard box with 10 bags containing 400 ml HIPRAHATCH solvent.
Cardboard box with 10 bags containing 500 ml HIPRAHATCH solvent.
Cardboard box with 10 bags containing 800 ml HIPRAHATCH solvent.
Cardboard box with 10 bags containing 1,000 ml HIPRAHATCH solvent.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.