Bovilis Bovipast RSP

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

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

थमां उपलब्ध:

MSD Animal Health UK Limited

ए.टी.सी कोड:

QI02AL04

INN (इंटरनेशनल नाम):

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

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Cattle

चिकित्सीय क्षेत्र:

Inactivated Viral and Bacterial Vaccine

प्राधिकरण का दर्जा:

Authorized

प्राधिकरण की तारीख:

1999-06-25

उत्पाद विशेषताएं

Revised: March 2023
AN:
00299/2022
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-3 virus, 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.
Revised: March 2023
AN:
00299/2022
Page 2 of 5
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
Do not vaccinate animals that have intercurrent diseas