List of excipients
Lyophilisate: BDA (bursal disease antibody), Cyclodextrin, Sucrose, Monosodium glutamate, Potassium dihydrogen phosphate, Dipotassium hydrogen phosphate.
Solvent (PBS): Sodium chloride, Potassium chloride, Disodium phosphate dihydrate, Potassium dihydrogen phosphate, Water for injections
Solvent (Saline solution): Sodium chloride, Water for injections.
Solvent (Cevac Solvent Poultry): Sucrose, Casein hydrolysate, Sorbitol, Dipotassium hydrogen phosphate, Potassium dihydrogen phosphate, Phenol red, Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except Vectormune ND and the solvents supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the lyophilisate as packaged for sale: 2 years.
Shelf life of the solvent (PBS) as packaged for sale: 43 months.
Shelf life of the solvent (Saline solution) as packaged for sale:
•Polyolefin based plastic bags equipped with infusion port, rubber stopper with flip off cap: 33 months
•Polyolefin based plastic bags equipped with single or double tubes, closed with injection port or rubber stopper with flip off cap: 2 years.
Shelf life of the solvent (Cevac Solvent Poultry) as packaged for sale: 30 months.
Shelf-life after reconstitution (in PBS, Saline solution or Cevac Solvent Poultry) according to directions: 2 hours.
Special precautions for storage
Lyophilisate: store and transport refrigerated (2oC-8oC).
Protect from light.
Solvents: store below 25oC
Do not freeze.
Nature and composition of immediate packaging
Lyophilisate:
Cardboard box with single or 20 glass vials (Type I) of 10 ml containing 2000, 2500, 4000 or 5000 doses, and of 13.5 ml containing 8000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
Solvent (PBS):
Cardboard box with single, 5 or 20 plastic bottles (LDPE), of 100, 200, 250, 400 or 500 ml solvent, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
Solvent (Saline solution):
•Polyolefin based plastic bags equipped with infusion port, rubber stopper with flip off cap: 500 ml, 1000 ml, 5 x 500 ml, 5 x 1000 ml.
•Polyolefin based plastic bags equipped with single or double tubes, closed with injection port or rubber stopper with flip off cap: 250 ml, 500 ml, 1000 ml, 5 x 250 ml, 5 x 500 ml, 5 x 1000 ml.
Solvent (Cevac Solvent Poultry):
Polyvinylchloride bag containing 200 ml, 400 ml, 800 ml, 1000 ml, 1200 ml, 1600 ml in individual over-pouch.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products 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.