5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution according to directions: 2 hours.
5.3 Special precautions for storage
Store and transport refrigerated (2 ºC - 8 ºC).
Do not freeze.
Protect from light.
5.4 Nature and composition of immediate packaging
Type I glass vials of 10 ml containing 1 000 doses, 5 000 doses and 10 000 doses of the freeze-dried vaccine, Type I bromobutyl rubber stoppers and sealed with aluminum caps.
Pack size:
Cardboard box with 1 lyophilisate vial containing 1 000 doses
Cardboard box with 1 lyophilisate vial containing 5 000 doses
Cardboard box with 1 lyophilisate vial containing 10 000 doses
Cardboard box with 10 lyophilisate vials containing 1 000 doses
Cardboard box with 10 lyophilisate vials containing 5 000 doses
Cardboard box with 10 lyophilisate vials containing 10 000 doses
Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.