CEVAC IBird Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bronchitis virus

Available from:

Ceva Animal Health Ltd

ATC code:

QI01AD07

INN (International Name):

Infectious bronchitis virus

Pharmaceutical form:

Lyophilisate for oculonasal suspension/use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2013-08-16

Summary of Product characteristics

Revised: June 2023
AN: 01012/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC IBird lyophilisate for oculonasal suspension/ use in drinking
water for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
Live, attenuated infectious bronchitis (IB) virus, strain 1/96,
2.8 – 4.3 log10 EID50*
*EID50 = 50 %Embryo infective dose: the virus titre required to
produce infection in
50% of the embryos inoculated.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/ use in drinking water.
Yellowish white pellet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of broiler and future layer chickens in
order to reduce the
detrimental effect on the ciliary activity and presence of virus in
trachea resulting from
the infection, which may be manifested in respiratory clinical signs.
Protection was
demonstrated by challenge with the 793/B strain, which is a
representative strain of
the 793/B group.
Onset of immunity: 3 weeks after one vaccination.
Duration of immunity: 6 weeks after one vaccination, except for future
layers in which
duration of immunity is 9 weeks after the first vaccination by
spraying.
Revised: June 2023
AN: 01012/2022
Page 2 of 6
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
All chickens on a site should be vaccinated at the same time and
within the same
premises.
The vaccine strain may spread to non-vaccinated chickens. Vaccinated
chickens may
excrete the vaccine strain for up to 28 days or longer following
vaccination.
During this time, the contact of immunosuppressed and unvaccinated
chickens with
vaccinated chickens should be avoided.
Care should be taken to avoid spread of the vaccine virus from
vaccinated chickens
to pheasants and turkeys.
Ce