SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Poulvac IB QX lyophilisate for suspension for spray for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose contains:

Active substance:

Live attenuated Avian Infectious Bronchitis Virus, strain L1148 10^3.0–10^5.0EID₅₀^*.

* EID50 = 50% Embryo Infective Dose.

Excipient:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension for spray.

Off-white, beige coloured. Upon reconstitution, transparent to white opaque suspension (depending on the volume of diluent used).

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

Do not vaccinate future layers/breeders before 1 week of age.

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.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

All chickens on the site should be vaccinated at the same time.

As there is a small range between the efficacious vaccine dose and a non-efficacious dose, take care to administer the right dose.

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.

4.6 Adverse reactions (frequency and seriousness)

In very rare cases, respiratory signs have been reported after vaccination: these signs are generally mild and last a few days.

The frequency of adverse reactions is defined using the following convention:

- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).

- Common (more than 1 but less than 10 animals in 100 animals).

- Uncommon (more than 1 but less than 10 animals in 1,000 animals).

- Rare (more than 1 but less than 10 animals in 10,000 animals).

- Very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of Poulvac IB QX has been demonstrated when administered during lay. The efficacy of Poulvac IB QX 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 Amounts 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.

Administration

Poulvac IB QX 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 manufacterer 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.

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

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Active immunisation against avian Infectious Bronchitis virus variant strain IB QX-like which causes infectious bronchitis in chickens

ATCvet code: QI01AD07

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

D-mannitol Gelatine

Myo-Inositol

Peptone

Water for injection

6.2 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 bottles.

Chlorobutyl rubber stoppers sealed with aluminium crimp caps.

Pack Sizes:

Box of 10 x 2000 doses

Box of 10 x 5000 doses

Box of 10 x 10 000 doses.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4175

9. DATE OF FIRST AUTHORISATION

27 June 2013

10. DATE OF REVISION OF THE TEXT

February 2016

Approved: 23 February 2016