Excipients
Vaccine: Sorbitol, Gelatin, Pancreatic digest of casein, Disodium phosphate dehydrate, Water for injections.
Solvent: Disodium phosphate dihydrate, Potassium dihydrogen phosphate. Water for injections.
Major incompatibilities
Do not mix with any other vaccine except the diluent supplied with the product or with the lepto and/or rabies vaccines of the Nobivac series (where these products and their combined use are authorised).
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
2 years at 2 – 8°C (after storage by the manufacturer for 29 months at -20°C).
Shelf-life after dilution or reconstitution according to directions: Use within 30 minutes.
Shelf life of the solvent: 4 years.
Special precautions for storage
Vaccine:
Store in a refrigerator (2 – 8°C).
Do not freeze.
Protect from light.
Care should be taken to avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
Solvent:
Store below 25°C if stored independently from the vaccine.
Immediate packaging
Vaccine:
Vial of hydrolytical class type I (Ph. Eur.) glass closed with a halogenobutyl rubber stopper and a colour coded aluminium cap.
Solvent:
Vial of hydrolytical class type I (Ph. Eur.) glass closed with a halogenobutyl rubber stopper and a colour coded aluminium cap.
Pack sizes: Carton or plastic box with 5, 10, 25 or 50 single dose vials.
Solvent may be packed together with the vaccine or separately.
Not all pack sizes may be marketed
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.