SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Avishield ND, lyophilisate for suspension, for chickens and turkeys

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose contains:

Active substance:

Live, lentogenic virus of Newcastle disease, strain La Sota 10^6.0to 10^7.0TCID₅₀

TCID₅₀= 50% Tissue culture infective dose

Excipients

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension.

Cream coloured lyophilisate.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens and turkeys.

4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

None.

4.4 Special warnings for each target species

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 recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA,vaccination programme should be planned accordingly.

It has been shown in laboratory studies that MDA interferes 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 is delayed by a week.

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

4.5 Special precautions for use

Special precautions for use in animals

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

Vaccinate only healthy birds.

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

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. Well-fitting masks and eye protection to European standards should be worn when handling the product. Hands should be washed and disinfected after vaccinating.

4.6 Adverse reactions (frequency and seriousness)

Respiratory disturbances after intranasal/ocular route of administration 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 displaying adverse reactions during the course of one treatment)

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

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

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

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

4.7 Use during pregnancy, lactation or lay

Laying birds:

Do not use in birds in lay.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

Vaccination

Chickens: 1 dose by coarse spray or oculonasal route 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 route 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 and taking the information provided in section 4.4 into account.

It is extremely important that all birds receive the full dose of vaccine and the 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 administration

Suspend 1000 doses of the vaccine in 100 ml distillate 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 administration

Suspend 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.

Vaccine should be suspended immediately before use.

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

In order to determine the quantity of water in which vaccine will be suspended

for the vaccinationof chickensina youngerage category (until third week of life),the following are guidelines:

It is important todissolvethe vaccinein theamountof water which will be drunk within1.5 - 2.5hours(taking into account thedifferent types of drinkingsystemsfor poultry).

In order to make the birds thirsty, withdraw the supply of drinking water up to 2 hours prior to immunisation (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. By spraying

It is recommended to resuspend 1000 doses of the vaccine in 150 - 300 ml of distilled water. The number of doses diluted corresponds to the number of birds in a 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.

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

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

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals, immunologicals for aves, domestic fowl, live viral vaccines, Newcastle disease virus/paramyxovirus

ATCvet code: QI01AD06

To stimulate active immunity against Newcastle disease virus. In the absence of a field infection with Newcastle Disease, efficacy by challenge was not demonstrated in field conditions.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Povidone K-25

Bacto peptone

Monosodium glutamate

Potassium dihydrogen phosphate

Potassium hydroxide

Dextran 40000

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after reconstitution: 3 hours.

6.4 Special precautions for storage

Store in a refrigerator (2 ºC - 8 ºC).

Protect from light.

6.5 Nature and composition of immediate packaging

The vaccine is filled into colourless glass vials (type I), which are closed with rubber stoppers and sealed with aluminium caps.

Carton or plastic box with 10 vials of 1000 doses of vaccine.

Carton or plastic box with 10 vials of 2500 doses of vaccine.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

GENERA Inc.

Svetonedeljska 2, Kalinovica,

10436 Rakov Potok

Croatia

Tel: +385 1 33 88 888

Fax: +385 1 33 88 650

E-mail: info@genera.hr

8. MARKETING AUTHORISATION NUMBER

Vm 43676/4000

9. DATE OF FIRST AUTHORISATION

26 April 2016

10. DATE OF REVISION OF THE TEXT

April 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 26 April 2016