Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Freeze dried vaccine of living attenuated infectious bronchitis virus strain H120, 103.0 - 104.9 EID50/dose.

Uses

For the vaccination of chickens to prevent respiratory disease caused by Massachusetts strains of avian infectious bronchitis virus and to act as a live primer for inactivated Massachusetts strain vaccines. The onset of immunity is from 25 days post vaccination. Protection of chicks will be of approximately 16 weeks duration at which age the chickens may be vaccinated with an appropriate inactivated IBV vaccine.

Dosage and administration

One dose per chicken to be administered by eye drop, with drinking water or by spray. The quantity of water to be used depends on the method of administration. Never use less than 1 dose per chicken.

Eye Drop:

For chickens at one day of age. Reconstitute vaccine by dissolving in deionised water for eye drop at the rate of 30 ml per 1,000 doses. The deionised water should be at room temperature when used. Administer by dropper at the rate of one drop per chick on to one eye. Hold the chicken so that one eye is pointing upwards and allow one drop of vaccine to fall into the eye. Chickens should swallow during vaccination.

Drinking water:

Discontinue any drinking water medication 24 hours before vaccination. Water containing a high level of free chlorine should not be used. A general indication is that if chlorine can be detected in the water by smell or taste it could deactivate the living virus. If so, half a litre (1 pint) of skimmed milk should be thoroughly mixed into every 20 litres (5 gallons) of water or skimmed milk powder added at a rate of two grams per litre of water before adding vaccine. Only perfectly clean and rust free utensils and drinkers (preferably plastic) free of any trace of disinfectants, detergents, soap, etc should be used. Ensure that there is enough drinking trough space to allow all chickens immediate access to the vaccine. No untreated water should be made available until the treated water has been consumed.

Withhold drinking water for 2 hours before vaccination to stimulate thirst. Remove the aluminium seal from the vaccine vial. To dissolve the vaccine pellet, the rubber stopper should then be removed whilst the vial is immersed in a plastic measuring jug containing 1 litre (approximately 1 quart) 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 and thoroughly mixed with sufficient drinking water to last for approximately 2 hours. The approximate drinking water requirements for vaccination can be calculated from the age of the chickens. Use as many litres of water as the age of the chickens in days, per 1000 chickens, up to a maximum of 40 litres per 1,000 chickens. Distribute the diluted vaccine evenly in the drinkers. Do not expose prepared drinking water vaccine to sunlight.

Return to regular watering only after the vaccine water has been consumed. The vaccine solution is best divided so that the drinkers are charged at least twice with vaccine to ensure a more widespread uptake.

If nipple drinkers are employed, ensure that header tanks are continually refilled with water containing vaccine.

The vaccine may be used in automatic watering equipment. However, the main supply should only be turned on when all the vaccine treated water has been consumed.

NB: Check that chickens are never left without water after vaccine treatment.

Coarse Spray:

This method may be used in the hatchery or on the farm.

Use a suitable sprayer and restrict use for vaccine only. If the Falcon 5S sprayer (5 litre capacity) is used replace the standard nozzle on this sprayer with a flat fan tip model - Lurmark tip - colour coded pink - reference no. 01F80. A black plastic lance adaptor will also be needed for this nozzle. The Cooper Pegler Knapsack sprayer, model CP3 is already equipped with the plastic lance adaptor, but the Lurmark flat fan tip nozzle should be fitted. The equipment should provide a droplet size of 0.12 to 0.15 mm diameter.

Pump sprayer up to 2 atmospheres and do not allow the pressure to drop below 1 atmosphere, when it should be recharged back to 2. The vaccine should be dissolved as described under drinking water administration. The vaccine concentrate should then be added to the water in the sprayer tank and thoroughly mixed. Use 0.15 to 0.5 litres of water per 1,000 chickens depending upon the type of spray equipment to be used. Spray the sides of the box first from a height of 30-50 cm (12-18 inches). Ensure no water spillage by rotating the sprayer end to spray into the box at each turn. The operator may need to stand on a box to correctly spray two boxes at the right angle. Hold chickens in boxes for approximately 30-45 minutes following vaccination.

Ensure the temperature in the holding area is 21-27ºC (70-80ºF) and draught free, to avoid chilling. Chickens should be neither overheated nor chilled following coarse spray vaccination.

Use clean vaccination materials.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in sick birds.

Can be used before the onset of lay in chickens intended for breeding.

Do not administer to birds in lay or within 4 weeks of point of lay.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.

Do not mix with any other vaccine/immunological product.

Adverse reactions:

A mild vaccination reaction can be observed in the form of transient, slight respiratory symptoms.

Special warnings:

Maternally derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the

timing of the vaccination programme should be planned accordingly. In any animal population there will be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal’s ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress, etc.

Special precautions for use in animals:

Care should be taken in the planning and implementation of vaccination programmes as vaccine virus may spread from vaccinates to non-vaccinated chickens. It is recommended that all chickens on a site be vaccinated with this product.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

If the vaccine is administered by spray, the eyes must be protected by safety goggles and the nose and mouth by a dust mask. A helmet with filtered air circulation may be used instead of goggles and a mask.

Withdrawal period: Zero days

Pharmaceutical precautions

Store and transport at +2°C - +8°C. Protect from light. Do not freeze. Keep out of reach and sight of children.

Shelf-life after dilution or reconstitution according to directions: 4 hours.

Legal category

POM-VPS

Packaging Quantities

10 x 2500 Doses

10 x 5000 Doses

Not all pack sizes may be marketed.

Further information

Disposal:

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

Marketing authorisation number

Vm 01596/4157.