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Qualitative and quantitative composition
Each 4 ml dose contains:
Active substances:
Lyophilisate
Bovine parainfluenza virus 3 (Pi3V), strain RLB 103, live
105.0 - 108.6 CCID50.
Bovine respiratory syncytial virus (BRSV), strain 375, live
105.0 - 107.2 CCID50.
CCID50 = Cell Culture Infectious Dose 50%.
Adjuvant:
Aluminium hydroxide gel
0.8 ml (equivalent to 24.36 mg of aluminium hydroxide).
Excipients:
Qualitative composition of excipients and other constituents
Lyophilisate:
Lactose Monohydrate
Potassium hydrogen phosphate
Dipotassium phosphate
Monopotassium L-glutamate
Water, purified
Gelatin
Casein hydrolysate solution
HALS medium
Solvent:
HALS medium
Lyophilisate: slightly whitish to yellowish freeze-dried pellet.
Solvent: pinkish to orange-brown turbid liquid, which might contain loose sediment. On shaking well, the sediment is easily resuspended.