Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Live attenuated vaccine against Infectious Bronchitis (strain CR88 (793B)) in chickens presented as a freeze dried pellet. Each dose contains at least 4.0 log10 EID50 live, attenuated Infectious Bronchitis Coronavirus, strain CR88121(793B).

Contains trace amounts of gentamycin and polymyxin.

Uses

Reduction of clinical signs and lesions of respiratory disease caused by the coronavirus variant, strain CR 88 (793B) in broiler chickens.

Dosage and administration

A single dose of vaccine to be administered by nebulization at 14 days of age.

The vaccine should be reconstituted in demineralised or distilled water (3 to 5 ml) then diluted in a volume appropriate for the type of spraying equipment to be used and the number of doses to be administered. Spray equipment should be used which is capable of consistently producing droplets of average diameter 80 – 150 μm. The vaccine should be sprayed as evenly as possible over the birds to ensure that each bird receives a full dose. Further information on appropriate equipment can be obtained from the manufacturer.

Contra-indications, warnings, etc

For animal treatment only.

Do not vaccinate unhealthy birds.

In the absence of trial data, future layers or breeders and chickens in lay must not be vaccinated.

In the absence of specific studies investigating possible interactions between vaccines, administration of other vaccines simultaneously with GALLIVAC IB88 cannot be recommended.

GALLIVAC IB88 vaccination does not replace the vaccination schedule against classical Infectious Bronchitis.

Vaccination may induce mild upper respiratory signs that may persist for a few days, depending on the health and condition of the chickens. The accidental administration of ten doses of vaccine may induce mild upper respiratory signs that persist for a few days, or a transient reduction in average weight gain, depending on the health and condition of the chickens.

The vaccinal virus can spread to non-vaccinated birds but no trend to reversion to virulence was demonstrated in laboratory trials. Nevertheless, care should be taken to prevent spread of vaccine virus to susceptible birds such as replacement layers and young birds.

Apply usual aseptic procedures.

Do not use “fogger”-type sprayer or equipment producing droplets of less than 50 microns for administration of the vaccine.

The ventilation system of the poultry house should be inoperative during administration of the spray.

Operator warnings

Care should be taken during reconstitution and administration of the vaccine. Operators should wear respiratory and eye protection conforming to current European standards. For further information contact the manufacturer.

Wash and disinfect hands after vaccinating.

Withdrawal period

Zero days.

Pharmaceutical precautions

Store between +2°C and +8°C, protected from light.

Keep out of reach of children.

Use demineralised or distilled water, free of disinfectant and/or antiseptic, for reconstitution of the vaccine.

Use clean equipment, free from any antiseptic and/or disinfectant for the preparation and administration of the vaccine. Do not mix with any other product.

After reconstitution, the vaccine should be used within two hours.

Empty containers or contaminated equipment should be disposed of safely, or sterilised by heat or immersion in approved disinfectant.

Legal category

POM-V

Packaging Quantities

1000 and 2000 dose vials, presented singly and in cartons of 10 bottles.

Further information

The vaccine contains the live attenuated CR88121 strain of Infectious Bronchitis, belonging to the CR88 (793B) group of the variant coronaviruses. After administration, the vaccine induces an active immunisation against the variant coronaviruses of group CR88 (793B). The duration of immunity is at least five weeks.

Marketing authorisation number

Vm 08327/4159.