SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CEVAC MASS L lyophilisate for oculonasal suspension for chicken

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (0.2 ml) contains:

Active substance:

Live, attenuated infectious bronchitis virus (IBV), Massachusetts B-48 strain

10^2.8- 10^4.3EID₅₀^*

*EID₅₀= 50% embryo infective dose

Excipients

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for oculonasal suspension.

Yellowish pellet.

4. CLINICAL PARTICULARS

4.1 Target species

Chicken

4.2 Indications for use, specifying the target species

For the active immunisation of chickens against infectious bronchitis (Massachusetts serotype), in order to reduce respiratory clinical signs, detrimental effect on the ciliary activity and presence of virus in the trachea.

Protection was demonstrated by challenge with the Massachusetts M41 strain.

Onset of immunity: 3 weeks following vaccination.

Duration of immunity: 6 weeks following vaccination.

4.3 Contraindications

None.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only.

Vaccinated chickens may excrete the vaccine strain for up to 28 days following vaccination.

During this time, special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated chickens and to other bird species, if any are close by.

All chickens within the same farm should be vaccinated before or when entering the premises.

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

Not applicable.

4.6 Adverse reactions (frequency and seriousness)

No significant clinical symptoms were detected after administration of the product. Mild tracheal rales commonly occurred in animals 4-6 days after vaccination, which resolved completely in a few days. In rare cases transient conjunctivitis can occur.

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

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

The safety of the veterinary medicinal product has not been studied during lay.

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

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

For nebulisation use.

The vaccine should be administered from one day of age, one dose / chicken.

Dilute the vaccine in distilled water, or in cold, clear water, free from disinfectants. The quantity of water should be sufficient to allow a uniform distribution of the vaccine when spraying the chickens. The 1000 dose vaccine is recommended to be dissolved in 200 ml water, whereas this ratio should be considered when dissolving other types of presentation.

Vaccination is recommended in the form of coarse spray assuring a droplet size of 100-200 µm. It is preferable that the chickens are sitting together in dim light or closely confined during spraying. The ventilation should be switched off during and after vaccination in order to avoid turbulences. Vaccination should be performed during the coolest time of the day.

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

No further reactions above the side effects mentioned under adverse reactions were observed after administering a 10-fold dose of the vaccine.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for Aves / domestic fowl / live viral vaccines

ATCvet code: QI01AD07

To stimulate active immunity against the Massachusetts serotype of avian infectious bronchitis virus in chickens.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Lactose

Sorbitol

Gelatine

Potassium dihydrogen phosphate

Dipotassium phosphate

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

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

Shelf life after dilution according to directions: 2 hours

6.4 Special precautions for storage

Store and transport refrigerated (2 °C - 8 °C).

Protect from light.

The diluted vaccine is to be kept below 25°C.

6.5 Nature and composition of immediate packaging

The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops.

Cardboard box with 1 vial of 1000 doses

Cardboard box with 1 vial of 2500 doses

Cardboard box with 1 vial of 5000 doses

Cardboard box with 10 vials of 1000 doses

Cardboard box with 10 vials of 2500 doses

Cardboard box with 10 vials of 5000 doses

Cardboard box with 20 vials of 1000 doses

Cardboard box with 20 vials of 2500 doses

Cardboard box with 20 vials of 5000 doses

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products 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 local requirements.

7. MARKETING AUTHORISATION HOLDER

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

8. MARKETING AUTHORISATION NUMBER

Vm 15052/4088

9. DATE OF FIRST AUTHORISATION

26 May 2016

10. DATE OF REVISION OF THE TEXT

May 2016

Approved: 26/05/2016