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Pharmaceutical particulars
List of excipients
Lyophilisate: Trometamol, Edetic acid, Sucrose, Dextran 70
Solvent (phosphate buffered saline): Sodium chloride, Potassium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium dihydrogen phosphate, Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product, except solvent recommended for use with the veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years. Shelf-life of the solvent as packaged for sale: 4 years. Shelf life after reconstitution according to directions: 2 hours
Special precautions for storage
Lyophilisate and solvent: Store and transport refrigerated (2°C – 8°C). Do not freeze. Protect from direct sunlight.
Reconstituted vaccine: Store below 25°C. Do not freeze
Nature and composition of immediate packaging
Lyophilisate: type I glass bottle (1, 5 or 10 doses) with a rubber stopper and aluminium cap.
Solvent: 3 ml (1 dose) or 10 ml (5 doses) type 1 glass bottle, or 20 ml (10 doses) type II glass bottle with a rubber stopper and an aluminium cap.
Pack size:
Cardboard box: 1 x 5 doses of lyophilised vaccine + 1x10 ml of solvent; 1 x 10 doses of lyophilised vaccine + 1 x 20 ml of solvent
Plastic box with a lid: 5 x 1 dose of lyophilised vaccine + 5 x 2 ml of solvent; 5 x 5 doses of lyophilised vaccine + 5 x 10 ml of solvent
Intranasal applicators are packaged separately. Applicators are distributed together with the vaccine.
Not all pack sizes may be marketed.
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 products should be disposed of in accordance with local requirements.