Bovilis Bovipast RSP suspension for injection for cattle

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Inactivated bovine respiratory syncytial virus strain ev908; Inactivated Parainfluenza-3-virus, strain SF-4 Reisinger; Inactivated mannheimia (pasteurella) haemolyticaA1, strain M4/1

Boleh didapati daripada:

Intervet Ireland Limited

Kod ATC:

QI02AL04

INN (Nama Antarabangsa):

Inactivated bovine respiratory syncytial virus strain ev908; Inactivated Parainfluenza-3-virus, strain SF-4 Reisinger; Inactivated mannheimia (pasteurella) haemolyticaA1, strain M4/1

Dos:

.

Borang farmaseutikal:

Suspension for injection

Jenis preskripsi:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Kumpulan terapeutik:

Cattle

Kawasan terapeutik:

bovine parainfluenza virus + bovine respiratory syncytial virus + pasteurella

Tanda-tanda terapeutik:

Immunological - Inactivated Vaccine

Status kebenaran:

Authorised

Tarikh kebenaran:

2000-06-06

Ciri produk

Registration file / April 2022
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
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
Registration file / April 2022
Do not vaccinate animals that have intercurrent disease, heavy
parasitic infestation or are in poor
general condit