Chickens (broilers).

For the active immunisation of broilers to reduce the severity of upper respiratory tract infections caused by Massachusetts and 793/B/91-type strains of avian infectious bronchitis virus.

Onset of immunity: 21 days after vaccination.

Duration of immunity: 6 weeks after vaccination.

Protection has also been demonstrated in the presence of maternally derived antibodies.

None.

Vaccinate healthy animals only.

The vaccine should not be used if an intercurrent infection is suspected.

The vaccine should not be used at sites where both broilers and breeders are kept.

Chickens should not be re-vaccinated.

The vaccine should only be used after it has been established that 793/B/91 like avian infectious bronchitis virus serotypes are epidemiologically relevant.

The vaccine strains can spread to in contact birds for up to 30 days after vaccination.

Special precautions should be taken to avoid spreading of the vaccine strain to pheasants.

It is recommended to vaccinate all chickens on a site with this product.

Personal protective equipment consisting of goggles and dust mask or a helmet with filtered air circulation should be worn when handling the veterinary medicinal product.

Not applicable.

Not applicable.

Chickens (broilers):

Common (1 to 10 animals / 100 animals treated):

Respiratory signs (including gasping, snicking and raling)1

1Generally mild; may be observed for approximately three 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 package leaflet for contact details.

Do not use in birds intended for laying or breeding.

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.

One dose of vaccine per bird by spray administration (oculonasal use) from one day of age.

This vaccine has been used in most types of spray equipment handsprayers (e.g. ASL Polyspray 2), knapsack sprayers (e.g. Birchmeyer with 0.55 or 1.6 mm spray nozzle, Gloria with 1.0 mm nozzle) or automatic spraying equipment (e.g. Bimex). The apparatus should be set to deliver a coarse spray (droplet size of 80-160 micrometres), allowing a dose of 0.5 ml per bird.

The lyophilised vaccine should be reconstituted with water of good quality at room temperature e.g. deionised water or good quality drinking water.

The lyophilised vaccine should be reconstituted as follows:

Remove the aluminium cap from the vial. To reconstitute the lyophilised vaccine, the rubber stopper should be removed whilst the vial is immersed in a plastic measuring jug containing 0.5 litre of clean cool water.

Half fill the vial with water, replace the stopper and shake to remove any remnants in the vial.

The content of the vial should then be added to the water in the jug, mixed well and transferred to the sprayer tank and thoroughly mixed. For the 5,000 dose vial a total amount of 2.5 l water is required and for the 10,000 dose vial a total amount of 5 l water should be used.

The chickens should be sprayed in chick boxes or brooding rings in the house to avoid loss of vaccine virus.

Upon reconstitution, transparent to white opaque suspension (depending on the volume of water used).

Administration of a 10-fold overdose does not result in symptoms different from those mentioned in section "Adverse reactions".

Zero days.