BOVILIS IBR

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INFECTIOUS BOVINE RHINOTRACHEITIS VIRUS STRAIN INT 1

Available from:

Intervet Ireland Limited

ATC code:

QI02A

Pharmaceutical form:

Pdr+Solv for Soln for Inj

Therapeutic group:

Immunological - Live Vaccine

Therapeutic area:

Bovine

Authorization date:

2003-06-06

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
per dose (2 ml)
_Active Substance(s):_
IBR virus, strain INT 1
> 5.6 log
10
TCID
50
grown in BEL 26 cells.
_Other ingredient(s):_
Traces of neomycin, polymixin, or gentamycin and amphotericin may be present in the product.
_Diluent:_
No ingredients knowledge of which is essential for the safe use of the product.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of cattle to reduce both clinical signs of disease and virus excretion after infection with
infectious bovine rhinotracheitis. The degree of protection afforded by use of the intramuscular route is slightly less
than following intranasal administration.
Cattle have been shown to be protected from the worst clinical effects of IBR within 2 days of intranasal and 7 days of
intramuscular vaccination with Bovilis IBR.
Where an outbreak of IBR occurs, in-contact animals may be vaccinated immediately with Bovilis IBR in an attempt to
prevent or reduce the severity of the disease. The vaccine should be used intranasally for this purpose.
Annual revaccination is recommended.
4.3 CONTRAINDICATIONS
None known
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/11/2006_
_CRN 7002474_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy animals should be vaccinated.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING