Each dose contains:

Live attenuated Avian Infectious Bronchitis Virus, strain L1148 103.0 –105.0 EID50*.

* EID50 = 50% Embryo Infective Dose.

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.

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.

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).

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.

Vaccinate only healthy animals.

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.

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.

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.

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 the national competent authority via the national reporting system. See also section 16 of the packaging leaflet for respective contact details.

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.

Do not mix with any other veterinary medicinal product.

Zero days

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.

Store and transport refrigerated (2 °C – 8 °C)

Do not freeze.

Protect from light.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after reconstitution according to directions: 2 hours.

Keep out of the sight and reach of children.

For animal treatment only.

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 10000 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.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

GB: Vm 42058/5103