Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A live attenuated Newcastle Disease Virus, strain Ulster 2C: 106.0-106.6 EID50 per dose.

Lyophilisate for reconstitution for eye drops solution, nasal drops solution, oral solution or nebulisation solution.

Uses

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

Dosage and administration

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

Poulvac NDW 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.

It is important to consult your veterinary adviser or Fort Dodge Animal Health technical staff before using the spray technique. Vaccination staff should always cover eyes and nose with protective equipment. A full face mask is recommended.

Intranasal

For use in birds from one 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 diluent to half fill the vial. Replace the rubber stopper and shake so that all the vaccine material is completely dissolved.

A convenient Diluent-Pak can be purchased from Fort Dodge Animal Health. Alternatively, you may purchase your sterile diluent and drop dispenser separately, in which case you will require 30ml of sterile diluent (in which the 1,000 doses of freeze-dried vaccine must be completely dissolved) and a drop dispenser calibrated to deliver at least three hundredths of a ml per drop. Pour the dissolved vaccine into the remaining diluent and shake again until completely mixed. The sterile diluent 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 (i.e. <1% fat) may be added to the water (2 – 4 grams per litre) or skimmed milk (1 litre per 5 gallons 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 nonchlorinated and contain as few as possible metal ions.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

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 Mareks 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 Mareks disease vaccines in the Poulvac range by Fort Dodge.

Do not vaccinate unhealthy birds.

Not for use during pregnancy and lactation.

Reconstitute vaccine immediately prior to use.

Use entire contents of vial within 2 hours.

Live Newcastle Disease Virus may cause conjunctivitis in man. When using this vaccine operators must protect eyes and nose by wearing goggles and a mask, especially with spray method.

When administering vaccine by the spray method operators must protect eyes and nose by wearing goggles and a full face mask. An appropriate helmet with filtered air circulation may be used.

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

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

As with any vaccine local and/or general reactions can occasionally occur. Such reactions are usually transient and incorrect vaccination technique may be involved.

Withdrawal period

Zero days.

Pharmaceutical precautions

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

Keep out of reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

Packs of 2,000, 5,000 and 10,000 in protective outers containing 10 vials.

Not all pack sizes may be marketed.

Further information

Poulvac NDW may be used with infectious bronchitis vaccine.

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 bird'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.

Marketing authorisation number

Vm 01596/4218.