Bovilis IBR marker Live
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
27-04-2012
Summary of Product characteristics
(SPC)
27-04-2012
Active ingredient:
BHV-1 strain GK/D 0
Available from:
Intervet Intenational BV
ATC code:
QI02AD01
Pharmaceutical form:
Suspension for injection
Therapeutic group:
bovine rhinotracheitis virus (IBR)
Therapeutic area:
Cattle
Authorization date:
2011-12-20
Patient Information leaflet
NL/V/0105/001/II/002 Day 90 label-leaflet
– 10-5-2007 Concurrent Use
1/7
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR Marker Live
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose (2 ml):
BHV-1, strain GK/D (gE¯ ): 10
5.7
- 10
7.3
TCID
50
.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for i.m. injection. / intranasal application.
4.
PACKAGE SIZE
1, 2, 5, 10, 25, 50 or 100 doses / 10x 1, 2, 5, 10, 25, 50 or 100 doses
5.
TARGET SPECIES
Cattle
6.
INDICATION(S)
Active immunisation against BHV-1 infection in cattle
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
I.M. / intranasal
1 dose of 2 ml.
Read the package leaflet before use. (_This sentence will only be mentioned once_)
8.
WITHDRAWAL PERIOD
Withdrawal period: zero days
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use. (_This sentence will only be mentioned once_)
10.
EXPIRY DATE
Use within 3 hours after reconstitution.
NL/V/0105/001/II/002 Day 90 label-leaflet
– 10-5-2007 Concurrent Use
2/7
11.
SPECIAL STORAGE CONDITIONS
Store at 2-8°C in the dark
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use. (_This sentence will only be mentioned once_)
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only
Subject to medical prescription (_to be replaced
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Summary of Product characteristics
Bovilis IBR marker Live SPC End of procedure NL/V/0105/001/II/003-004 13-12-2007
1
Final SPC 13-12-07
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR marker Live
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml reconstituted vaccine:
ACTIVE SUBSTANCE(S)
BHV-1, strain GK/D (gE¯ ): 10
5.7
- 10
7.3
TCID
50
.
ADJUVANT(S)
None
SOLVENT (Unisolve)
Isotonic phosphate buffered saline.
For a list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for intramuscular injection or intranasal
application.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle to reduce the intensity and duration of the clinical
respiratory signs induced by an infection with BHV-1 and to reduce nasal excretion of
field virus.
Onset of immunity:
An increase in immunity was demonstrated 4 days after intranasal vaccination and 14
days after intramuscular vaccination of 3 month old seronegative animals.
Duration of immunity:
After intranasal administration to 2 week old calves without maternal antibodies,
immunity lasts at least until the age of 3-4 months, when the animals should be
revaccinated. In the presence of maternally derived antibodies, the protection of the
vaccine may not be complete until this revaccination.
Revaccination at 3-4 months of age results in protective immunity that lasts for at least
6 months.
Bovilis IBR marker Live SPC End of procedure NL/V/0105/001/II/003-004 13-12-2007
2
Si
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