Bovilis Bovipast RSP

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

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

から入手可能:

MSD Animal Health UK Limited

INN（国際名）:

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

医薬品形態:

Suspension for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Cattle

治療領域:

Inactivated Viral and Bacterial Vaccine

認証ステータス:

Authorized

承認日:

1999-06-25

製品の特徴

Revised: August 2020
AN: 00299/2020
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
5.5
– 10
6.4
TCID
50
*
Inactivated Parainfluenza-3Virus, strain SF-4 Reisinger
10
7.3
– 10
8.3
TCID
50
*
Inactivated _Mannheimia haemolytica _A1_, _strain M4/1_ _9 x 10
9
cells
* Antigen concentration that induces antibody levels in rabbits not
significantly lower
than that of a standard preparation; TCID
50
= tissue culture infective dose 50%
ADJUVANTS:
Aluminium hydroxide
37.5 mg
Quil A (Saponin)
0.625 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.
Revised: August 2020
AN: 00299/2020
Page 2 of 5
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