Poulvac IB QX Lyophilisate for Oculonasal Suspension for Chickens

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Infectious bronchitis virus

متاح من:

Zoetis UK Limited

ATC رمز:

QI01AD07

INN (الاسم الدولي):

Infectious bronchitis virus

الشكل الصيدلاني:

Lyophilisate for oculonasal suspension

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Chickens

المجال العلاجي:

Live Viral Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2013-06-27

خصائص المنتج

Revised: April 2023
AN: 01321/2022
Page 1 of 5
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:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension.
Off-white, beige coloured lyophilisate.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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.
4.3
CONTRAINDICATIONS
None.
Revised: April 2023
AN: 01321/2022
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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