Poulvac NDW, Lyophilisate for reconstitution for eye drops solution, nasal drops solution, oral solution or nebulisation solution, for chickens

Description

Avian infectious bursal disease (Gumboro disease) vaccine (live), freeze-dried.

Active Ingredients	Per dose
Live Newcastle Disease Virus, strain Ulster 2C	10^6.0 – 10^6.6 EID₅₀

INDICATIONS

For active immunisation of chickens to reduce mortality and clinical signs due to infection with Newcastle Disease.

CONTRAINDICATIONS

Do not vaccinate unhealthy birds.

ADVERSE REACTIONS

None

TARGET SPECIES

Chickens from one day of age.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

Vaccination schedule
Broilers:
For spray or eye/nose drop administration.
One dose per broiler chicken to be administered via spray or eye/nose drop from one day of age. An additional dose may be required for broilers or so called heavy roaster birds to be taken beyond 45 days of age at slaughter.
Future layers, Breeders:
One dose by spray or eye drop at one day of age. Revaccination by atomiser at 4 and 10 weeks of age. Where atomiser administration is impossible, revaccination by drinking water may be carried out.
Spray:
The product has been successfully used in most types of spray equipment; the droplet sizes varying from coarse (knapsack) to very fine (aerosol). 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 one litre (approximately 1 quart) of clean cool water. Half fill the vial with water, replace the stopper and shake to dissolve any remaining vaccine. Stir carefully to ensure even dispersal of vaccine. The vaccine concentrate should then be added to the water in the sprayer tank and thoroughly mixed. Use deionised water or cold clean drinking water containing as little chlorine and as few metal ions as possible.
Vaccination should preferably be performed in the hatchery by handspray, automatic spraying equipment or by eye/nose drop. Later vaccination should be given by an atomiser. For spray administration, 250-500 mls of water per 1,000 chicks in the hatchery and 500 mls per 1,000 chicks on the farm is recommended.
Spray Method:
Hand spray and automatic spraying equipment (coarse drop spray):

Spray the birds (the distance from the spraying head to the birds must be approximately 50 cm) and make sure all the birds get the vaccine directly.
Use drops with a diameter of 0.12 – 0.15 mm.
In warm weather, vaccination should preferably take place during the coolest part of the day.

Atomiser:

Use the atomiser preferably in position 5 (drop size +0.05 mm).
The birds should not be touched directly, but the area must be sprayed.
Ensure that the ventilation is switched off and that air intakes and outlets are closed during vaccination and for twenty minutes afterwards.
In warm weather, vaccination should preferably take place during the coolest part of the day.

After atomiser vaccination, intake of the vaccine by the birds is by inhalation. The air volume per bird in 30 minutes is independent of the number of birds per house (per m3). Therefore the vaccine concentration in the air has to be constant and independent of the number of birds per house volume (m3). For a good immune response about 10 doses per m3 (giving at least 107 EID50 per m3) are required. This means that the number of doses needed has to be calculated on the size of the house expressed in m3 and multiplied by 10.
Intranasal:
For use in birds from day of age. Reconstitute the vaccine as directed below. Fit the drop dispenser on the bottle. Place finger over one nostril of the bird, allow one drop of the vaccine to fall into the other nostril. Vaccination is completed when the vaccine is inhaled into the nasal cavity. Do not release the bird until this occurs.
Eye Drop:
For use in birds from one day of age. Reconstitute the vaccine as directed below. Fit the drop dispenser on the bottle. Hold the bird so that one eye is pointed upwards and allow one drop of vaccine to fall into the eye. Birds should swallow during vaccination.
Reconstitution for intranasal and Eye Drop Routes:

Remove the aluminium foil and rubber stopper from the vaccine vial and add sterile water for injections to half fill the vial. Replace the rubber stopper and shake so that all the vaccine material is completely dissolved.
Dissolve the freeze-dried pellet in 30 ml sterile diluent for each 1000 doses. Shake gently until completely dissolved. The sterile water for injections should be at room temperature when used.

Drinking Water:

Make sure that all conduit pipes, tubing, troughs, drinkers etc are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc.
Allow water to be consumed so that levels in drinkers are minimal before vaccine is applied. If water is still present, drain lines before applying vaccine. Apply vaccine over up to 3 hours, ensuring that all birds drink during this time. It may be necessary to withhold water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period.
Open the vaccine ampoule under water. Mix the contents of the vaccine ampoule with cold and fresh drinking water at the rate of 1,000 doses of the vaccine to 1 litre of water per day of age for 1,000 chickens. As the concentrated vaccine is slightly viscous, care should be taken to empty the ampoule and its top completely by rinsing them in water. Low-fat skimmed milk powder (ie <1% fat) may be added to the water (2 – 4 grams per litre) or skimmed milk (1 litre per 23 litres of water) to increase the stability of the virus. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water. Ideally vaccine should be administered in the volume of water consumed by the birds in up to 3 hours. If in doubt, measure water intake the day before administering vaccine.
Use the dissolved vaccine immediately following preparation.
Avoid exposure of the vaccine suspension to sunlight.
Water used for drinking administration of a live virus vaccine must be non-chlorinated and contain as few as possible metal ions

WITHDRAWAL PERIOD

Zero days.
National label conditions must be observed by country.

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Reconstituted vaccine should be used within 2 hours.

SPECIAL STORAGE PRECAUTIONS

Store and transport at +2°C to +8°C.
Protect from light.
Do not freeze.

SPECIAL WARNINGS

Not for use during pregnancy and lactation.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except the live infectious bronchitis and Marek's disease vaccines in the Poulvac range by Fort Dodge. 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 medicinal product except the live infectious bronchitis and Marek's disease vaccines in the Poulvac range by Fort Dodge.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Live Newcastle disease virus may cause conjunctivitis in man. When using the vaccine, operators must protect eyes and nose by wearing goggles and a full-face mask, especially with spray method. An appropriate helmet with filtered air circulation may be used instead of goggles and a mask.
On completion, operators should wash and disinfect hands in an approved disinfectant.
Dispose of waste material by boiling, incineration or immersion in appropriate disinfectant in accordance with national requirements.

OTHER INFORMATION

ATCVet Code: QI01AD06
Nature and composition of immediate packaging
Container: Type I hydrolytic glass vials.
Closures: Butyl rubber (PhEur) and aluminium tear-off cap.
Size: 10 x 2,000, 10 x 5,000 or 10 x 10,000 dose vials.
Not all pack sizes may be marketed.
National label conditions must be observed by country.

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