BRONIPRA 1

Freeze-dried tablet for suspension

QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE ACTIVE SUBSTANCE(S):

One dose (0,03 ml) contains:

Active substance:

Attenuated live Infectious Bronchitis Virus, strain H120: 103 - 105.4 EID50** Egg infective doses 50%.

INDICATIONS FOR USE:

To prevent avian Infectious Bronchitis in broilers, breeders and layers.

CONTRAINDICATIONS: Not applicable.

UNDESIRABLE EFFECTS:

None has been described. If you notice any serious effects not mentioned in this lea_et, please inform your veterinarian.

TARGET SPECIES: Poultry (broilers, breeders and layers).

POSOLOGY FOR EACH TARGET SPECIES, METHOD AND ROUTES OF ADMINISTRATION:

Poultry: 1 dose/bird.

The veterinary surgeon will establish the most suitable vaccination programme according to the health conditions of each farm and area.

ADVICE ON CORRECT ADMINISTRATION:

Ocular-nasal: Mix the solvent with the freeze-dried tablet using the delivered decanted and gently stir.

Administer one drop of the vaccine (0.03 ml) per bird, in the eye or nostril, using a standard dropper (normally 32 ml per 1,000 doses).

Drinking water: Dissolve the freeze-dried powder by _lling the _ask in which it is contained to half volume withfresh tap water (do not use chlorinated water or with disinfectants and avoid high temperatures in coater), shake and pour it into an adequate container up to a volume of drinking water that can be ingested within ½ or 1 hour at most, keeping in mind that:

            Age of the bird                                 Approximate amount of water for 1,000 birds

             1 to 3 weeks                                                                5 to 10 litres

             4 to 9 weeks                                                               12 to 23 litres

           10 to 16 weeks                                                             27 to 37 litres

Spray: Validate the apparatus to be used to check the necessary amount of water. To do this, _ll the apparatus with fresh tap water and spray the surface which birds occupy, in a manner so that the heads of all the birds are covered with droplets of water. Check the quantity of water used, and this will be the amount that will have to be used to mix with the necessary doses, depending on the number of birds to be vaccinated.

The following volumes could be used as guidance values:

           No. of doses                         1-day-old chicks (large drops)                     Older birds (fine drops)

                  1000                                             200-250 ml                                                500-1000 ml

WITHDRAWAL PERIOD:

Zero days.

SPECIAL PRECAUTIONS FOR STORAGE:

Keep out of the reach and sight of children. Store and transport refrigerated (+2 to +8 ºC). Do not freeze. Protected from light. Once reconstitued, use immediately.

SPECIAL WARNINGS:

Special warnings for each target species

Vaccinate only healthy animals. If the number of birds does not coincide with the number of doses of available vials, never administer less than the recommended dosage.

 Special precautions for use in animals

Check the shelf life of the product. Do not expose the vaccine to disinfectants, detergents, heat or sunlight, as it is sensitive to them. Avoid high temperatures in water where the freeze-dried fraction is diluted.

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

Spray administration requires the use of protective mask and glasses.

Use during pregnancy, lactation or lay

 Not applicable.

 Interactions with other vaccines and medicinal products when administered in combination with the product

No information is available on the safety and ef_cacy 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.

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

 None has been described when administered 10 times the recommended dose.

Incompatibilities

Do not mix with any other veterinary medicinal product.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS

DERIVED FROM THE USE OF SUCH PRODUCTS:

Medicines should not be removed in sewage pouring or by household waste. Ask your veterinarian or pharmacist how to dispode unused medicines. These measures are designed to

protect the environment.

OTHER INFORMATION:

Pack sizes:

Cardboard box with 10 vials of 1000, 2500 or 5000 doses.