Pharmaceutical particulars
Qualitative and quantitative composition
Each dose of 2 ml contains:
Active substances:
Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 105.2 - 106.5 CCID50*
Live gE- tk- double-gene deleted bovine herpesvirus type 1 (BoHV-1), strain CEDDEL 106.3 - 107.6 CCID50*
Inactivated bovine parainfluenza 3 virus (PI-3), strain SF4 ≥ 206.2 EU**
E2 recombinant protein from bovine viral diarrhoea virus type 1 (BVDV-1) ≥ 31.6 EU**
E2 recombinant protein from bovine viral diarrhoea virus type 2 (BVDV-2) ≥ 21.0 EU**
gE-: deleted glycoprotein E; tk-: deleted thymidine kinase E2: E2 structural glycoprotein
* Cell Culture Infectious Dose 50 %
** ELISA Units
Adjuvant:
Montanide IMS 1.010 g
Excipients: Qualitative composition of excipients and other constituents
Lyophilisate: Dipotassium phosphate, Gelatin, Glycine, Potassium dihydrogen phosphate, Sorbitol, Sucrose
Solvent: Disodium phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Sodium chloride, Water for injections
Lyophilisate: white-to-yellow colour. Solvent: white translucent emulsion.
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life of the solvent as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 2 hours.
Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C). Do not freeze.
Protect from light.
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.