Bovilis IBR Marker Live, Lyophilisate and Solvent for Suspension for Cattle

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Infectious bovine rhinotraceitis virus

Saadav alates:

Intervet International BV

INN (Rahvusvaheline Nimetus):

Infectious bovine rhinotraceitis virus

Ravimvorm:

Nasal drops, suspension

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Cattle

Terapeutiline ala:

Live Viral Vaccine

Volitamisolek:

Authorized

Loa andmise kuupäev:

2002-02-13

Toote omadused

Revised: June 2017
AN: 00480/2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis IBR marker Live lyophilisate and solvent for suspension for
cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml reconstituted vaccine contains:
ACTIVE SUBSTANCE(S)
Live bovine herpesvirus type 1 (BHV-1), strain GK/D (gE¯ )
*
: 10
5.7
- 10
7.3
TCID
50
**
.
*
gE¯: glycoprotein E negative
**
TCID
50
: tissue culture infective doses 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension.
Lyophilisate: off-white to light pink-coloured pellet.
Solvent: colourless solution.
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 immunity lasts at
least until the
age of 3-4 months. In the presence of maternally derived antibodies,
the protection
of the vaccine may not be complete until a second vaccination. This
second
vaccination should be administered at 3-4 months of age and will
result in protective
immunity that lasts for at least 6 months.
Single intranasal or intramuscular vaccination of 3 months old animals
provides
protective immunity (reduction of clinical signs and reduction of
viral excretion),
which was demonstrated via challenge 3 weeks after vaccination.
Reduction of viral
excretion is maintained for at least 6 months after single
vaccination.
Page 1 of 7
Revised: June 2017
AN: 00480/2016
Revaccination to ensure protection after the initial 6 month
protection period has
elapsed will result in protective immunity that lasts for 12 mon