Poulvac IB QX lyophilisate for oculonasal suspension for chickens

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Live attenuated avian infectious bronchitis virus strain L1148

Beschikbaar vanaf:

Zoetis Belgium S.A.

ATC-code:

QI01AD07

INN (Algemene Internationale Benaming):

Live attenuated avian infectious bronchitis virus strain L1148

Dosering:

. 50% Embryo Infective Dose/dose

farmaceutische vorm:

Lyophilisate for suspension for spray administration

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Chickens

Therapeutisch gebied:

avian infectious bronchitis virus

therapeutische indicaties:

Immunological - Live Vaccine

Autorisatie-status:

Authorised

Autorisatie datum:

2013-09-06

Productkenmerken

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac IB QX lyophilisate for oculonasal suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
Live attenuated Avian Infectious Bronchitis Virus, strain L1148
10
3.0
– 10
5.0
EID
50
*.
*EID
50
= 50% Embryo Infective Dose.
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
D-mannitol
Gelatine
Myo-Inositol
Peptone
Water for injection
Off-white, beige coloured lyophilisate.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For active immunisation of chickens in order to reduce respiratory
signs of Infectious Bronchitis
caused by QX-like variants of Infectious Bronchitis virus.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 63 days after vaccination.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
The vaccine virus is capable of spreading to in contact birds for a
minimum of 14 days after
vaccination and appropriate care should be taken to separate
vaccinated from non-vaccinated chickens.
Precautionary measures should be taken to prevent spreading to
wildlife.
Cleaning and disinfection of the premises after vaccination is
advisable.
This vaccine should only be used after it has been established that
the QX-like IBV variant strain is
epidemiologically relevant.
It is important to avoid introduction of the IB QX vaccine virus into
premises in which the wild type
strain is not present. The IB QX vaccine should only be applied in
hatcheries if adequate controls are
in place to avoid the spread of the vaccine virus to birds that will
be transported to non-IB QX exposed
flocks.
The vaccine has been demonstrated to provide protection against
QX-like variant. The protection
against other circulating IB strains has not been investigated.
As there is a small range between the efficacious vaccine dose and a
non-efficacious dose, take care to
administer the right dose.
Vaccinate healthy animals o