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 containing Newcastle Disease Vaccine (Living) Hitchner B1 strain, 105.5 - 107.2 EID50 per dose.

Uses

For the primary and booster vaccination of healthy chickens, turkeys and game birds against Newcastle disease (Fowl Pest).

Dosage and administration

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

Drinking Water

For birds 2 weeks of age or older. Never use less than one dose per bird. Discontinue any drinking water medication 24 hours before vaccination.

1.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 by taste it could deactivate the living virus. If so 1 pint (500 ml) of skimmed milk should be thoroughly mixed into every 5 gallons (20 litres) of water before adding the vaccine. Only perfectly clean and rust free utensils and drinkers (preferably plastic) should be used, and disinfectants and detergents 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 the water 1-2 hours before vaccination to stimulate thirst.

2.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.

3.The vaccine concentrate should then be added to and thoroughly mixed with sufficient drinking water to last for approximately 2 hours.

4.The approximate drinking water requirements are given in table 1.

5.Distribute the diluted vaccine evenly in the drinkers.

6.Do not expose prepared drinking water vaccine to sunlight.

7.Return to regular watering only after the vaccine water has been consumed.

8.The vaccine solution is best divided so that the drinkers are charged at least twice with the vaccine to ensure a more widespread uptake.

9.If nipple drinkers are employed, ensure that header tanks are continually refilled with water containing vaccine.

10.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.

Table 1: Approximate drinking water requirements
	Quantity per 1,000 birds
Age of Birds	Gallons	Litres
First week	½–1	2–4
Weeks 2–4	2–2½	8–10
Weeks 5–7	3-4	12–16
8 weeks and over	4½-5	18–20

NB: Check that all birds are never left without water after vaccine treatment.

Spray

For birds 4 weeks of age or older.

Hitchner B1 vaccine, has been successfully used in most types of spray equipment, the droplet sizes varying from coarse (Knapsack) to very fine (aerosol).

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.

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 can result under certain management conditions. Spray vaccination should not be used if inter-current infection is suspected.

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 upward and allow one drop of vaccine to fall into the eye.

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 30 ml 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.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

1.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.

2.Only healthy birds should be vaccinated.

3.Use entire contents of vial when first opened.

4.Keep out of the reach and sight of children.

5.Ensure all vaccine-medicated drinking water is consumed within 2 hours.

6.When administering vaccine by the spray method operators must protect eyes and nose by wearing goggles and a mask.

7.On completion of vaccination all empty or part-used vials should be burnt or immersed in a disinfectant approved for use under the Diseases of Animals (Approved Disinfectants) Orders.

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

9.Withdrawal Period: Zero days.

Pharmaceutical precautions

To be stored at +2°C to +8°C. Do not freeze. Protect from light.

Prepared drinking water vaccine should be protected from sunlight.

Opened vials and water to which vaccine has been added must be used immediately and not stored.

Legal category

POM-VPS

Packaging Quantities

1,000 dose and 5,000 dose vials, in protective outer containing 10 vials.

Not all pack sizes may be marketed.

Further information

An immunity capable of resisting challenge to infection is normally produced in 7 to 10 days following vaccination of susceptible chicks, and lasts for approximately 3 to 4 months. Where necessary revaccination at 3 to 4 month intervals is advisable.

Suggested vaccination programmes are available on request.

In any animal population there will be a small number of individuals which fail to respond 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 01596/4335.