Bovilis Bovipast RSP

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Mannheimia haemolytica

Commercializzato da:

MSD Animal Health UK Limited

INN (Nome Internazionale):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Mannheimia haemolytica

Forma farmaceutica:

Suspension for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cattle

Area terapeutica:

Inactivated Viral and Bacterial Vaccine

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

1999-06-25

Scheda tecnica

Revised: March 2023
AN: 00297/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Bovipast
RSP, suspension for injection for cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (5 ml) contains:
ACTIVE SUBSTANCES:
Inactivated Bovine Respiratory Syncytial virus, strain EV908 10
4.77
– 10
5.45
U/dose
*
Inactivated Parainfluenza-3Virus, strain SF-4 Reisinger
10
3.54
– 10
4.85
U/dose
*
Inactivated _Mannheimia haemolytica _A1_, _strain M4/1
10
4.24
– 10
5.00
U/dose
*
*Results obtained with AlphaLISA assays
ADJUVANTS:
Aluminium hydroxide
37.5 mg
Quil A (Saponin)
0.189 – 0.791 mg
EXCIPIENTS:
Thiomersal
0.032 – 0.058 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The product is pale yellow to red-pink with whitish sediment. By
shaking the sediment
is easily suspended to an opaque, whitish to red/pink suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of cattle against:
- Parainfluenza-3 virus, to reduce infection,
- Bovine Respiratory Syncytial virus, to reduce infection and clinical
signs,
- _Mannheimia haemolytica _serotype A1, to reduce infection,
mortality, clinical signs,
lung lesions and bacterial invasion of the lung caused by serotypes A1
and A6.
Cross-reactive immunity to the A6 serotype of _Mannheimia haemolytica_
has been
demonstrated in a challenge experiment under laboratory conditions
after primary
course of vaccination.
Approximately two weeks after completion of the basic immunisation
programme, the
humoral immune response against Bovine Respiratory Syncytial virus and
Revised: March 2023
AN: 00297/2022
Page 2 of 5
Parainfluenza-3 virus is at its highest level. The duration of
protective immunity has
not been established in challenge experiments.
Onset of immunity: 2 weeks.
Duration of immunity: not established.
4.3
CONTRAINDICATIONS
Do not vaccinate animals that have intercurrent disease