SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Poulvac IB H120

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance per dose:

Live, attenuated Avian Infectious Bronchitis Virus Strain H120: 10^3.0 – 10^4.9EID₅₀

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension

4. CLINICAL PARTICULARS

4.1 Target species

Chickens

4.2 Indications for use, specifying the target species

For the active immunisation of chickens in order to reduce the detrimental effect on the ciliary activity resulting from infection with Infectious Bronchitis virus serotype Massachusetts, which is related to the development of respiratory clinical signs

Onset of immunity: 25 days

Duration of immunity: 16 weeks

4.3 Contraindications

Do not use in sick animals.

4.4 Special warnings for each target species

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.

4.5 Special precautions for use

Special precautions for use in animals

The vaccine virus spread from vaccinated to non-vaccinated chickens. Care should be taken in the planning and implementation of vaccination programmes and 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.

4.6 Adverse reactions (frequency and seriousness)

A mild vaccination reaction can be observed very rarely (less than 1 animal in 10,000 animals) in the form of transient, slight respiratory symptoms

4.7 Use during pregnancy, lactation or lay

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

Do not use in birds in lay and within 4 weeks before the onset of the laying period.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

Vaccination Schedule

One dose per chicken to be administered by eye drop, with drinking water or by coarse 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. Use 30 to 50 ml of deionized water per 1000 doses (birds) depending of the type of eye-dropper to be used. One drop equal to one dose (0.03 to 0.05 ml depending on the reconstituted volume) of the vaccine solution is administered into one eye per chicken. The deionised water should be at room temperature when used. 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 of skimmed milk should be thoroughly mixed into every 20 litres 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.

The product can be used in most types of spray equipment. The equipment should provide coarse spray (droplets between 80 to 160 μm). The distance from the spraying head to the bird must be approximately 50 cm. Use 0.15 to 0.5 litres of water per 1000 birds depending of the type of spray equipment to be used.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Reactions after administration of an overdose are not different from those after a single dose application.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against Massachusetts strain of infectious bronchitis virus.

ATCvet code: QI01AD07

Environmental properties

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

D-Mannitol

Gelatin

Myo-inositol

Casein enzymatic hydrolysate

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

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

6.4. Special precautions for storage

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

Protect from light.

Do not freeze.

6.5 Nature and composition of immediate packaging

Nature: Hydrolytic Type I glass (Ph. Eur.) vial

Closure: Type I butyl rubber elastomer (Ph. Eur.) stoppers and aluminium overseal.

Pack sizes: 1,000, 2,500, 5,000 or 10,000 doses per vial in boxes of 1 or 10 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4101

9. DATE OF FIRST AUTHORISATION

17 October 2005

10. DATE OF REVISION OF THE TEXT

January 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 09/01/2014