Avishield IB GI-13, lyophilisate for oculonasal suspension/use in drinking water for chickens

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Avian infectious bronchitis virus, live

Fáanlegur frá:

GENERA Inc

ATC númer:

QI01AD07

INN (Alþjóðlegt nafn):

Avian infectious bronchitis virus, live

Skammtar:

.

Lyfjaform:

Lyophilisate for oculonasal suspension/use in drinking water

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

avian infectious bronchitis virus

Leyfisstaða:

Authorised

Leyfisdagur:

2020-05-29

Vara einkenni

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield IB GI-13, lyophilisate for oculonasal suspension/use in
drinking water for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
Live avian infectious bronchitis virus, variant strain V-173/11: 10
2.7
- 10
4.6
EID
50
*
* EID
50
= 50% Embryo infective dose.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/use in drinking water.
Cream to yellow 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 in order to reduce the
detrimental effect on the ciliary activity
resulting from infection by avian infectious bronchitis virus,
serotype 793B (GI-13 lineage), which
may be manifested in respiratory clinical signs.
Onset of immunity:
10 days after vaccination.
Duration of immunity:
56 days after vaccination.
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.
Chickens can be vaccinated in the presence of MDA: immunity in
chickens with MDA will be
developed 21 days after vaccination.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
All birds in the flock should be vaccinated at the same time.
The vaccine strain is excreted from respiratory and intestinal tract
_._
Appropriate measures should be
taken to prevent contact between vaccinated and non-vaccinated
animals. Measures should be taken to
prevent spread to wild animals. Housing should be cleaned and
disinfected after each production
cycle.
The vaccine strain can spread to susceptible, unvaccinated chickens
for a minimum of 28 days
following vaccination. It is possible that the vaccine virus can be
spread to non-target susceptible
species.
Avishield IB GI-13 is intended to protect chickens against respiratory
signs of disease cau