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Pharmaceutical particulars
Excipients
Lyophilisate:
Sodium chloride
Potassium Chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Solvent:
Light mineral oil
Aluminium hydroxide
Sorbitan oleate
Polysorbate 80
Ethyl alcohol
Glycerol
Sodium chloride
Sodium hydroxide
Water for injections
Major incompatibilities
Do not mix the lyophilisate with any other veterinary medicinal product, except the recommended “Solvent for Porcilis Lawsonia” or Porcilis PCV M Hyo.
Shelf-life
Shelf life of the lyophilisate as packaged for sale: 3 years.
Shelf life of the solvent as packaged for sale: 3 years.
Shelf-life after reconstitution according to directions: 6 hours
Special precautions for storage
Lyophilisate and solvent:
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
Immediate packaging
Lyophilisate:
Hydrolytic glass Type I vial of 50 doses or 100 doses closed with halogenobutyl rubber stoppers and sealed with aluminium caps.
Solvent:
PET (polyethylene terephthalate) vials of 100 ml (50 doses) or 200 ml (100 doses), closed with nitryl rubber stoppers and sealed with aluminium caps.
Presentations:
Cardboard box with 1 x 50 doses of vaccine and cardboard box with 1 x 100 ml solvent
Cardboard box with 10 x 50 doses of vaccine and cardboard box with 10 x 100 ml solvent
Cardboard box with 1 x 100 doses of vaccine and cardboard box with 1 x 200 ml solvent
Cardboard box with 10 x 100 doses of vaccine and cardboard box with 10 x 200 ml solvent
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.