SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cevac IBD 2512 L

avian infectious bursal disease vaccine for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Live infectious bursal disease (IBD) virus strain, Winterfield 2512, G-61 2.0 log10 to 3.2 log10 EID50*/dose

* EID50 (embryo infectious dose 50%)

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for oral suspension.

Blue lyophilisate, to be reconstituted in the drinking water.

4. CLINICAL PARTICULARS

4.1 Target species

Chicken (broilers, from 10 days of age).

4.2 Indications for use, specifying the target species

For the active immunization of broiler chickens with maternally-derived antibodies against infectious bursal disease (IBD, gumboro disease), to reduce mortality, clinical disease, weight loss and acute lesions in bursa of Fabricius, caused by very virulent infectious bursal disease virus.

The onset of immunity is 14 days post-vaccination.

The duration of immunity is: until 27 days post-vaccination.

4.3 Contraindications

Do not use in unhealthy birds.

Do not use in infected flocks with clinical symptoms.

Do not use for immunisation of flocks without maternally derived antibodies (MDA). (See section 4.5.)

4.4 Special warnings for each target species

The vaccine contains an “intermediate-plus” virus strain that is known to cause immunosuppression and bursal damage (see sections 4.5, 4.6 and 5). Consequently, the vaccine is only indicated for immunisation of chicken having maternal antibodies and exposed to very virulent IBD virus strains.

4.5 Special precautions for use

Special precautions for use in animals

It is not recommended to vaccinate birds younger than 10 days of age, regardless of the level of maternally derived antibodies (see section 4.9).

The vaccine contains an “intermediate-plus” virus strain, causing significant immunosuppression and bursal damage when inoculated into birds without MDA. Vaccinated birds may excrete the vaccine virus that may subsequently spread to susceptible birds. To prevent spread of vaccine virus, vaccinating equipment and chicken houses should be disinfected between flocks.

The product should be only used after it has been demonstrated that very virulent IBDV strains are epidemiologically relevant in the area of vaccination.

Vaccinate all the birds in a flock at the same time.

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

Personnel performing vaccination should wash and disinfect hands and equipment after use.

4.6 Adverse reactions (frequency and seriousness)

Data from safety studies involving administration of a single dose to the target species (10 day old chickens withMDA to IBDV) are not available.

4.7 Use during pregnancy, lactation or lay

Do not use for layers and breeders.

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

Dosage: 1 dose / chicken.

For oral administration, via reconstitution in drinking water.

For vaccination of broiler chickens from a minimum of 10 days of age to approximately 18 days of age, depending on the level of maternally derived antibodies.

The optimal timing of vaccination should be determined on the basis of virus neutralisation (VN) titres measured in 1- to 7-day-old chickens. The flock to be vaccinated should have a geometric mean VN titre of <1:450 at vaccination.

To estimate MDA level of the flock to be vaccinated: 20, preferably 1-day-old chicks (maximum 7 day old) originating from the same breeding flock should be sampled to measure their serological status to IBDV by VN. From the results of this sampling and based on the 3 days half-life-time for the IBDV MDA, the most suitable time for vaccination can be determined.

Preparation and administration of the vaccine:

The number of vaccine doses should be dissolved in the amount of drinking water calculated upon water consumption of the birds to be immunized.

Number of doses should be rounded up for smaller flocks and dissolved accordingly (i.e. dissolve 20,000 doses for the treatment of 19,450 birds).

Drinking water must not contain disinfectants for 48 hours prior to and for 24 hours after vaccination. Also chlorination of drinking water should be avoided during this period.

Instruments used for preparation and administration of the vaccine must be free of residues of disinfectants.

Drinkers should be cleaned thoroughly before vaccination. Do not apply disinfectants for cleaning of the watering system for vaccination.

Drinking water should be withdrawn from birds for 2 to 4 hours prior to vaccination, depending on their age and the temperature of the house.

To preserve virus activity, it is advised to dissolve 2.5 g skimmed milk powder per litre of calculated drinking water, prior to dissolving the vaccine.

Open the vaccine vial under water and rinse it thoroughly after dissolution. Stir to dissolve the vaccine, distribute it to watering system proportionally and make it available to the chickens. It is advised to increase the number of drinkers during vaccination. To ensure that all birds have access to the vaccinated water, it is advised to move birds around the drinkers in the first few minutes of vaccination. The birds can be supplied with fresh drinking water only after the medicated water is consumed entirely.

The vaccine should be administered to birds immediately after reconstitution.

Administer the vaccine during the coolest part of the day.

Protect reconstituted vaccine from direct sunshine.

Protect birds to be vaccinated from stress conditions.

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

From studies involving a 10 fold overdose of Winterfield 2512 L G61 vaccine strain administered to 1 day old and 7 day old chickenswithout maternally derived antibodies (i.e. SPF chickens) the following was noted:

In day-old SPF chickens: Lesions of 2.2. scores in the bursa of Fabricius were observed by 28 days post vaccination as well as a slower growth rateup tothree weeks of age.

In 7 day old SPF chickens: Clinical signs of infectious bursal disease were not detected. No oedema, haemorrhage or necrosis was detected in the bursa of any chicken by the end of 21-days observationperiod.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

ATCvet code: QI01AD09

Pharmacotherapeutic group: avian infectious bursal disease virus (gumboro disease).

For active immunisation against infectious bursal disease virus (gumboro disease, IBD).

The vaccine contains live, attenuated, intermediate plus, Winterfield 2512, G61 strain of IBD virus.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactalbumin hydrolisate

Sucrose

Sodium-L-glutamate

Potassium dihydrogene phosphate

Dipotassium phosphate

Patent blue (E131)

6.2 Incompatibilities

Chlorides and metal ions in the drinking water may interfere with the vaccine virus.

Residues of disinfectants on the surface of instruments to be applied for preparation and administration of the vaccine may interfere with the live virus, hence may reduce vaccine efficiency.

6.3 Shelf life

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

Shelf life after reconstitution according to directions: 2 hours

6.4. Special precautions for storage

Store and transport refrigerated (2^oC – 8^oC). Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

Lyophilised vaccine: 1000, 2500 and 5000 doses in type I glass vials of 3ml and 10ml volume, sealed with rubber stopper and aluminium cap.

20 vials in a box.

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. MARKETING AUTHORISATION HOLDER

Ceva Animal Health Ltd

Unit 3

Anglo Office Park

White Lion Road

Amersham

Bucks.

HP7 9FB

8. MARKETING AUTHORISATION NUMBER

Vm 15052/4059

9. DATE OF FIRST AUTHORISATION

7 November 2012

10 DATE OF REVISION OF THE TEXT

November 2012

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of Cevac IBD 2512 L vaccine 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 Cevac IBD 2512 L vaccine must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.