1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis ND C2

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance

Live attenuated Newcastle disease virus (NDV) strain C2: 5.7 - 7.5 log₁₀EID₅₀* per dose.

*EID₅₀= 50% Embryo infective dose: the virus titre required to produce infection in 50% of the embryos inoculated

Excipients:

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Lyophilisate for suspension for oculonasal or spray application.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens

4.2 Indications for use, specifying the target species

Active immunisation of chickens against Newcastle disease virus to reduce clinical signs and mortality.

Onset and duration of immunity: 2 and 5 weeks after vaccination of seronegative animals, respectively.

Onset of protection is demonstrated at 2 weeks after vaccination of animals with maternally derived antibodies.

Duration of immunity is in accordance with the vaccination programme.

4.3 Contraindications

Do not vaccinate clinically ill (especially respiratory disease) or stressed birds.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

The vaccine virus may spread to unvaccinated birds up to 10 days post vaccination. This spread does not induce clinical signs but may lead to seroconversion in unvaccinated chickens.

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

Live Newcastle disease vaccines may cause a mild transient conjunctivitis in the person administering the vaccine. Appropriate measures should be taken to prevent this.

Wash and disinfect hands and equipment after vaccinating. When used by spray, contact of eyes and airways with the vaccine virus should be prevented. Wear a face mask.

4.6 Adverse reactions (frequency and seriousness)

Ice-cold vaccine administered via the eye/nose drop method may cause blinking or headshaking.

4.7 Use during pregnancy, lactation or lay

Not to be used during lay or within 4 weeks before the onset of lay (as the safety of this has not been investigated).

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 vaccine except the live Intervet vaccines against infectious bronchitis (strain H120) and rhinotracheitis (strain 11/94). Marek's disease vaccine (strains CVI988-FC126) and infectious bronchitis vaccine (strain IB Ma 5) are compatible with Nobilis ND C2 when given on day 1 (the efficacy of the Marek and IB Ma5 vaccines has not been investigated). Infectious bursal disease vaccine (strain D78) can be given 7 days after Nobilis ND C2.

A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to made on a case by case basis.

4.9 Amounts to be administered and administration route

Administration via eye- or nose-drop method or via (coarse) spray.

Single vaccination with one dose per animal from 1 day of age onwards.

Eye- or nose-drop administration

Reconstitute the vaccine with the appropriate amount of a suitable diluent and administer by means of a standardised dropper (of which the droplet size is known and consistent). Sterile distilled water or phosphate buffered saline can be used. The amount of diluent required for eye- or nose-drop administration depends on the number of doses and the droplet size, but approximately 35 ml per 1000 doses is used. One drop should be applied into one nostril or one eye. Ensure that the nasal drop is inhaled before freeing the bird.

Spray

Reconstitute the vaccine in cool, clean water, to which 2% skimmed milk may be added. Chlorinated water should not be used. The water and spray apparatus should be free from sediments, corrosion and traces of disinfectants or antiseptics. Ideally the apparatus should be used for vaccination purposes only. The volume of diluent for reconstitution should be sufficient to ensure an even distribution when sprayed onto the birds. This will vary according to the age of the birds being vaccinated and the management system, but 250 to 500 ml of water per 1000 doses is suggested. The vaccine suspension should be sprayed evenly over the birds at a distance of 30-40 cm, preferably when the birds are sitting together in dim light. If applicable, reduce or stop ventilation to prevent loss of spray.

Vaccination programme

Nobilis ND C2 can be given from 1 day of age onwards. Because the immunity which is induced by vaccination with Nobilis ND C2 is not long lasting, an extended vaccination programme should be followed. To maintain a required level of immunity, chickens should receive a secondary vaccination 2-3 weeks after administration of this vaccine, with a live vaccine containing the more invasive Clone 30 strain.

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

No other signs than after a single dose are seen after administration of ten times the maximum dose via the recommended routes.

4.11Withdrawal period

Zero days

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Live Newcastle disease virus vaccine.

ATCvet-code: QI01AD06

To stimulate immunity against Newcastle disease in chickens.

The attenuated C2 strain is lentogenic and of low pathogenicity, and is therefore suitable from 1 day of age.

Priming effect of ND C2 has been demonstrated exclusively by secondary vaccination of chickens with the live NDV vaccine containing the more invasive Clone 30 strain.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitol

Hydrolysed gelatine

Pancreatic digest of casein

Disodium phosphate dihydrate

Water, purified

6.2 Incompatibilities

Do not use with any other veterinary medicinal product, except the products mentioned under section 4.8.

6.3 Shelf life

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

Shelf-life after reconstitution according to directions: 3 hours.

6.4 Special precautions for storage

Store in a refrigerator (2C - 8C). Do not freeze. Protect from light.

Store below 25°C after reconstitution.

6.5 Nature and composition of immediate packaging

Cardboard box containing 1 or 10 vials of glass (hydrolytic type II) with halogenobutyl rubber stopper and metal cap.

Contents per vial: 500, 1000, 2500, 5000, 10 000 or 25 000 doses.

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

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

7. MARKET AUTHORISATION HOLDER

Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton Milton Keynes MK7 7AJ

Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest Road Dublin 24

8. MARKETING AUTHORISATION NUMBER(S)

Vm 06376/4045

VPA 10996/187/1

9. DATE OF RENEWAL OF THE AUTHORISATION

23 March 2010

10. DATE OF REVISION OF THE TEXT

29 July 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of Nobilis ND C2 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use Nobilis ND C2 must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.