Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A freeze-dried pellet or powder containing live infectious bronchitis vaccine virus strains H120, 103.0 - 105.4 EID50 and D274 clone, 103.0 - 105.4 EID50 per dose.

Uses

For active immunisation of chickens to reduce upper respiratory tract infections caused by strains of the Massachusetts serotype and Dutch variant strains D207/D274.

The onset of immunity is from 27 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 product.

Dosage and administration

One dose per chicken to be administered 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 bird.

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) should be used, and disinfectants must not be used for cleaning. Ensure that there is enough drinking trough space to allow all birds immediate access to the vaccine. No untreated water should be 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 birds. Use as many litres of water as the age of the birds in days, per 1000 birds, up to a maximum of 40 litres per 1000 birds.

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 birds are never left without water after vaccine treatment.

Spray:

Poulvac IB primer has been used in most types of spray equipment. The equipment should provide a droplet size of 0.12 to 0.15mm diameter. The distance from the spraying head to the bird must be approximately 50 cm. Use 0.15 to 0.5 litre of water per 1000 birds depending upon the type of spray equipment to be used.

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.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in sick chickens.

Do not use in birds in lay or breeding birds.

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

The safety of the veterinary medicinal product has not been established during lay.

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

No information is available on the safety and efficacy from the concurrent use of Poulvac IB Primer with any other except Poulvac NDW and Poulvac SHS, administered by the spray route to maternal antibody positive chicks. It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with the product.

Do not mix with any other vaccine/immunological product.

It is recommended to spray vaccinate in a sealed cabinet. Alternately, the eyes and face of vaccination staff should be protected by a full face mask approved to BS2091 (e.g. a Siebe-Gorman vista type) and eye goggles should be worn. A helmet with filtered air circulation may be used instead of goggles and mask.

On completion, operators should wash and disinfect hands in an Approved Disinfectant.

Adverse Reactions:

A mild vaccination reaction can be observed in the form of transient, slight respiratory symptoms such as occasional sneezing and coughing. No harmful clinical effects have been observed. Tracheal histopathology revealed very low scores in the post vaccination period.

Special Warnings:

It is accepted that spray administration offers benefits over water administration in terms of ease of application and percentage of birds vaccinated. Nevertheless, greater secondary problems may result under certain management conditions. Spray vaccination should not be used if intercurrent infection is suspected. It is important to consult your veterinary adviser or Fort Dodge Animal Health technical staff before using the spray technique.

Efficacy against infectious bronchitis caused by the 4/91 (793B) UK variant IB strain has not been demonstrated.

Pharmaceutical precautions

Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.

Keep out of the reach and sight of children.

Keep the container in the outer carton.

Reconstituted vaccine should be used within 4 hours.

Legal category

POM-V

Packaging Quantities

1000 dose and 5000 dose vials, in protective outers containing 10 vials.

Not all pack sizes may be marketed.

Further information

Following vaccination of susceptible chicks, immunity lasts up to approximately 3 to 4 months. Thereafter vaccination using other vaccine based on M41 or D207/D274 strains may be advisable.

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 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.

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.

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 01596/4217.