Excipients
Lyophilisate: culture medium, chemically defined stabiliser CD#279 (patented)
Solvent: dl-α-tocopheryl acetate, polysorbate 80, sodium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, simethicone, water for injection.
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied with the product or with Porcilis M Hyo.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale.
Lyophilisate: 2 years.
Solvent: In glass vials 4 years, in PET vials 2 years.
Shelf life after reconstitution according to directions: 3 hours.
After mixing with Porcilis M Hyo: 1 hour.
Special precautions for storage
Vaccine or combined packaging: store in a refrigerator (2 °C – 8 °C).
Protect from light.
Solvent: store below 25 °C.
Immediate packaging
Lyophilisate container:
Glass Type I vial (Ph.Eur.), closed with a halogenobutyl rubber stopper (Ph.Eur.) and
sealed with a coded aluminium cap.
Solvent container:
Glass Type I vial (Ph.Eur.) or PET-flask, closed with a halogenobutyl rubber stopper
(Ph.Eur.) and sealed with a coded aluminium cap.
IM presentation:
Cardboard box with 1 vial of lyophilisate (10 doses)
Cardboard box with 1 vial of lyophilisate (25 doses)
Cardboard box with 1 vial of lyophilisate (50 doses)
Cardboard box with 1 vial of lyophilisate (100 doses)
Cardboard box with 10 vials of lyophilisate (10 doses)
Cardboard box with 10 vials of lyophilisate (25 doses)
Cardboard box with 10 vials of lyophilisate (50 doses)
Cardboard box with 10 vials of lyophilisate (100 doses)
Cardboard box with 1 vial of lyophilisate (10 doses) and 1 vial of solvent (20 ml).
Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of solvent (50 ml).
Cardboard box with 1 vial of lyophilisate (50 doses) and 1 vial of solvent (100 ml).
Cardboard box with 1 vial of lyophilisate (100 doses) and 1 vial of solvent (200 ml).
Cardboard box with 10 vials of lyophilisate (10 doses) and 10 vials of solvent (20 ml).
Cardboard box with 10 vials of lyophilisate (25 doses) and 10 vials of solvent (50 ml).
Cardboard box with 10 vials of lyophilisate (50 doses) and 10 vials of solvent (100 ml).
Cardboard box with 10 vials of lyophilisate (100 doses) and 10 vials of solvent (200 ml).
Cardboard box with 1 vial of lyophilisate (10 doses) and a cardboard box with 1 vial of solvent (20 ml).
Cardboard box with 1 vial of lyophilisate (25 doses) and a cardboard box with 1 vial of solvent (50 ml).
Cardboard box with 1 vial of lyophilisate (50 doses) and a cardboard box with 1 vial of solvent (100 ml).
Cardboard box with 1 vial of lyophilisate (100 doses) and a cardboard box with 1 vial of solvent (200 ml).
Cardboard box with 10 vials of lyophilisate (10 doses) and a cardboard box with 10 vials of solvent (20 ml).
Cardboard box with 10 vials of lyophilisate (25 doses) and a cardboard box with 10 vials of solvent (50 ml).
Cardboard box with 10 vials of lyophilisate (50 doses) and a cardboard box with 10 vials of solvent (100 ml).
Cardboard box with 10 vials of lyophilisate (100 doses) and a cardboard box with 10 vials of solvent (200 ml).
ID presentation:
Cardboard box with 1 vial of lyophilisate (10 doses) and 1 vial of solvent (2 ml).
Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of solvent (5 ml).
Cardboard box with 1 vial of lyophilisate (50 doses) and 1 vial of solvent (10 ml).
Cardboard box with 1 vial of lyophilisate (100 doses) and 1 vial of solvent (20 ml).
Cardboard box with 5 vials of lyophilisate (10 doses) and 5 vials of solvent (2 ml).
Cardboard box with 5 vials of lyophilisate (25 doses) and 5 vials of solvent (5 ml).
Cardboard box with 5 vials of lyophilisate (50 doses) and 5 vials of solvent (10 ml).
Cardboard box with 5 vials of lyophilisate (100 doses) and with 5 vials of solvent (20 ml).
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.