Poulvac IB H120

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

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Herunterladen Fachinformation (SPC)
04-05-2024

Wirkstoff:

Infectious bronchitis virus

Verfügbar ab:

Zoetis UK Limited

ATC-Code:

QI01AD07

INN (Internationale Bezeichnung):

Infectious bronchitis virus

Darreichungsform:

Lyophilisate for suspension

Verschreibungstyp:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapiegruppe:

Chickens

Therapiebereich:

Live Viral Vaccine

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2005-10-17

Fachinformation

                                Revised: May 2024
AN: 00294/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac IB H120 lyophilisate for suspension for oculonasal use, ocular
use or use in
drinking water for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
Live attenuated avian infectious bronchitis virus, strain H120:
10
3.0
– 10
4.9
EID
50
*
*EID
50
= 50% embryo infective dose.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for oculonasal use, ocular use or use in
drinking water.
Off-white to cream coloured lyophilisate.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens (broilers, future layers or
breeders) in order
to reduce the detrimental effect on the ciliary activity resulting
from infection with
infectious bronchitis virus (IBV) Massachusetts serotype strains,
which is related to
the development of respiratory clinical signs.
Onset of immunity: 25 days after vaccination.
Duration of immunity: 16 weeks.
Revised: May 2024
AN: 00294/2023
Page 2 of 7
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Maternally derived antibodies (MDA) can interfere with the development
of active
immunity. Where it is likely that recent field infection or
vaccination of the parent flock
has stimulated a high antibody titre and consequently a high level of
MDA, the timing
of the vaccination programme should be planned accordingly.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The vaccine strain can spread to unvaccinated chickens. Special
precautions should
be taken to avoid spreading of the vaccine strain to unvaccinated
chickens. It is
recommended to vaccinate all birds on a site at the same time.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Personal protective equi
                                
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