Poulvac IB QX
Active substance
ATC code
Species
Chickens.
Indications
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.
Dose to be administered and administration route
Vaccination schedule
Broilers: one dose of vaccine from 1 day of age by spray vaccination.
Future layers or breeders: one dose of vaccine from 7 days of age by spray vaccination. The vaccine may be administered as early as 1 day of age to future layers or breeders with MDAs against IBV.
Administration
The veterinary medicinal product can be used in most types of spray equipment. The equipment should provide coarse spray (droplets greater than 100 μm). The distance from the spraying head to the bird is dependent upon the type of sprayer used. It is recommended to consult the instructions from the manufacturer of the spraying device before use. Resuspension volumes vary based upon the type of spray equipment as well. The recommended resuspension volume for 1 dose is between 0.15 and 0.5 ml.
Remove the aluminium seal from the vaccine vial. To dissolve the vaccine pellet, the rubber stopper should be removed whilst the vial is immersed in a plastic measuring jug containing 1 litre of clean cool water. Half fill the vial with water, replace the stopper and shake to dissolve any remaining vaccine. The vaccine concentrate should then be added to the water in the spray tank and thoroughly mixed.
Administer at a rate of one dose of prepared vaccine per bird.
Upon reconstitution, transparent to white opaque suspension (depending on the volume of diluent used).
Adverse reactions
Chickens:
|
Very rare (< 1 animal / 10,000 animals treated, including isolated reports) |
respiratory signs1 |
1Generally mild and last a few days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
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 103.0 – 105.0 EID50*. *EID50 = 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.
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 vaccine dose and a non-efficacious dose, take care to administer the right dose.
Vaccinate healthy animals only.
4.5 Special precautions for use
i) Special precautions for use in animals
All chickens on the site should be vaccinated at the same time.
When vaccination is planned in future layers or breeders younger than 7 days, the parent flock should be vaccinated with an IB vaccine to ensure progeny with MDAs against IBV.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken when reconstituting and administering the vaccine. Wear a suitable respiratory mask and eye protection to avoid direct contact with the aerosolized vaccine. Wash and disinfect hands after use.
iii) Special precautions for the protection of the environmentNot applicable.
4.6 Adverse reactions (frequency and seriousness) Chickens:
|
Very rare (< 1 animal / 10,000 animals treated, including isolated reports) |
respiratory signs[1] |
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.
4.7 Use during pregnancy, lactation or lay
Laying birds:
The safety of the veterinary medicinal product has been demonstrated when administered during lay. The efficacy of the veterinary medicinal product has not been demonstrated when administered during lay.
A decision to use this vaccine during lay should be made on a case by case basis.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amount(s) to be administered and administration route
Vaccination schedule
Broilers: one dose of vaccine from 1 day of age by spray vaccination. Future layers or breeders: one dose of vaccine from 7 days of age by spray vaccination. The vaccine may be administered as early as 1 day of age to future layers or breeders with MDAs against IBV.
Administration
The veterinary medicinal product can be used in most types of spray equipment. The equipment should provide coarse spray (droplets greater than 100 μm). The distance from the spraying head to the bird is dependent upon the type of sprayer used. It is recommended to consult the instructions from the manufacturer of the spraying device before use. Resuspension volumes vary based upon the type of spray equipment as well. The recommended resuspension volume for 1 dose is between 0.15 and 0.5 ml.
Remove the aluminium seal from the vaccine vial. To dissolve the vaccine pellet, the rubber stopper should be removed whilst the vial is immersed in a plastic measuring jug containing 1 litre of clean cool water. Half fill the vial with water, replace the stopper and shake to dissolve any remaining vaccine. The vaccine concentrate should then be added to the water in the spray tank and thoroughly mixed.
Administer at a rate of one dose of prepared vaccine per bird.
Upon reconstitution, transparent to white opaque suspension (depending on the volume of diluent used).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Renal lesions (paleness, microscopic lesions) can be observed after administration of a 10-fold overdose.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
ATCvet Code: QI01AD07
Active immunisation against avian Infectious Bronchitis virus variant strain IB QX-like which causes infectious bronchitis in chickens.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
D-mannitol
Gelatine
Myo-Inositol
Peptone
Water for injection
6.2 Major Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after reconstitution according to directions: 2 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Glass vial closed with chlorobutyl rubber stopper and sealed with an aluminium crimp cap.
Pack Sizes:
Box of 1 x 2000 doses
Box of 1 x 5000 doses
Box of 1 x 10 000 doses
Box of 10 x 2000 doses
Box of 10 x 5000 doses
Box of 10 x 10 000 doses
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/5103
9. DATE OF FIRST AUTHORISATION
27 June 2013
10. DATE OF REVISION OF THE TEXT
April 2023
PROHIBITION OF SALE, SUPPLY AND/OR USE
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Approved 21 April 2023
