Chickens and turkeys.

For active immunisation of chickens to reduce mortality and clinical signs due to infection with Newcastle disease virus. Onset of immunity: 21 days post vaccination. Duration of immunity: 35 days post vaccination.

For active immunisation of turkeys to prevent mortality and clinical signs due to infection with Newcastle disease virus. Onset of immunity: 21 days post vaccination. Duration of immunity has not been investigated.

Vaccinate healthy animals only.

The vaccine strain can spread to susceptible, unvaccinated birds for at least 10 days following vaccination. The spread does not induce clinical signs.

Vaccine virus can disseminate to the trachea, spleen, kidneys, lung, caecal tonsils, duodenum and brains of chickens without inducing pathological changes to these organs.

Maternally Derived Antibodies (MDA) can interfere with the development of active immunity.

Where it is likely, for example, that a recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the vaccination programme should be planned accordingly.

It has been shown in laboratory studies that MDA interfere with vaccination by the spray and oral route and can result in up to 55% unprotected birds 3-4 weeks post vaccination. Better protection in these studies was seen by oculonasal delivery but the onset of immunity was delayed by a week.

Influence of MDA on vaccination in turkeys has not been investigated.

All birds in the flock should be vaccinated at the same time.

Care should be taken when handling and administering the vaccine.

Newcastle disease virus can cause a mild transient conjunctivitis in the person administering the vaccine. Personal protective equipment consisting of a mask and eye protection should be worn when handling the veterinary medicinal product. Wash and disinfect hands after administration of the vaccine.

Respiratory disturbances after oculonasal use occur very commonly. These symptoms could last at least two weeks.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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

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.

Chickens: 1 dose by coarse spray or oculonasal use from the age of 1 day. The vaccine can be administered in drinking water at the time when birds are drinking continuously from the drinking system.

Turkeys: 1 dose by coarse spray, oculonasal use or drinking water from the age of 14 days.

Method of application depends on the epizootiological situation, age, category and number of animals. The veterinarian should determine the optimum vaccination schedule according to the local situation taking into account the information provided in Special warnings for each target species.

It is extremely important that all birds receive the full dose of vaccine. Details presented below should be strictly followed to achieve this.

If prolonged immunity is required, chickens can be revaccinated after 35 days. Revaccination in turkeys has not been investigated.

1. Oculonasal use

Reconstitute 1000 doses of the vaccine in 100 ml distilled water.

A dose of reconstituted vaccine is 0.1 ml, i.e. two drops, irrespective of poultry age, weight and type. Instil one drop into the eye and one drop into the nose opening.

2. Drinking water use

Reconstitute the vaccine in cool and clean water without traces of chlorine, other disinfectants or impurities in a number of doses corresponding to the number of birds to be vaccinated.

The vaccine should be reconstituted immediately before use.

The volume of water for reconstitution depends on the age of the birds, the breed, the management practice and weather conditions.

In order to determine the quantity of water in which vaccine will be reconstituted for the vaccination of chickens in a younger age category (until the third week of life), the following guideline applies:

- multiplying the number of birds in the thousands with the day of life (e.g. 1 thousand chickens in the 7th day of life = 1 x 7 = 7 L)

It is important to reconstitute the vaccine in the amount of water which will be drunk within 1.5-2.5 hours (taking into account the different types of drinking systems for poultry).

In order to make the birds thirsty, withdraw the supply of drinking water up to 2 hours prior to vaccination (depending on the air temperature).

Always make sure that there is food available when vaccinating. Birds will not drink if they have no food to eat. The drinking system should be clean, without traces of chlorine, other disinfectants or impurities.

3. Coarse spray

It is recommended to reconstitute 1,000 doses of the vaccine in 150–300 ml of distilled water. The number of doses to be used corresponds to the number of birds in the flock. The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the birds, and will vary according to the age of the birds being vaccinated and the management system.

The reconstituted vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30–40 cm using a coarse spray, preferably when the chickens are sitting together in dim light. The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only. During and after vaccination ventilation should be switched off in order to avoid turbulences.

Slightly open mouth breathing was seen very commonly 5-9 days post vaccination after application of a tenfold overdose by coarse spray; these symptoms disappeared within 10 days.

Zero days.