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Qualitative and quantitative composition
Each 4 ml dose contains:
Active substances:
Lyophilisate:
Parainfluenza 3 virus, modified live strain RLB 103
105.0 - 108.6 CCID50
Bovine Respiratory Syncytial Virus, modified live strain 375
105.0 - 107.2 CCID50
Suspension:
Bovine Virus Diarrhoea Virus Type 1, inactivated strains 5960 (cytopathic) and 6309 (non‑cytopathic), to induce a GMT seroneutralisation titre in guinea pigs of at least 3.0 log2
CCID50 = Cell Culture Infectious Dose 50%.
Adjuvant:
Alhydrogel 2%
0.8 ml (equivalent to 24.36 mg of aluminium hydroxide)
Excipients:
Qualitative composition of excipients and other constituents
Lyophilisate:
Buffered lactose solution
Gelatin solution
Casein hydrolysate solution
Suspension:
HALS medium
Lyophilisate: slightly coloured freeze-dried pellet.
Suspension: slightly coloured turbid liquid which might contain a loose sediment. On shaking well, the sediment is easily resuspended.