SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cevac Meta L lyophilisate for suspension for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose contains:

Active substance:

Live, attenuated avian metapneumovirus subtype B, strain CRR126 2.5-3.8 log10 TCID50*

*TCID50 = 50% Tissue cultureinfective dose: the virus titre required to produce infection in 50% of the tissue cultureinoculated.

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension

Yellowish white lyophilisate

4. CLINICAL PARTICULARS

4.1 Target species

Chicken

4.2 Indications for use, specifying the target species

For active immunisation of future layer chickens in order to reduce respiratory signs and virus shedding associated with infection by avian metapneumovirus which is known to be the primary etiological agent of Swollen Head Syndrome.

Onset of immunity: 3 weeks.

Duration of immunity: 9 weeks.

4.3 Contraindications

None

4.4 Special warnings for each target species

Vaccinate healthy birds only.

4.5 Special precautions for use

Special precautions for use in animals:

Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination.

The vaccine strain can spread to unvaccinated birds.

In order to reduce the chance of circulation of the vaccine strain, it is recommended to vaccinate all susceptible animals on a site, preferably at the same time

Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species such as cleaning and disinfection procedures.

Unvaccinated birds should be separated from vaccinated chicken.

Turkeys in contact with vaccinated chickens may react to the vaccine strain, presenting clinical signs such as slight sneezing or conjunctivitis which may last for 2-3 days.

It is advised not to vaccinate in the presence of other sensitive species (guinea fowl, pheasantand Muscovy ducks), taking into account the spread of the vaccine strain and the lack of safety data for these species.

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

Personal protective equipment consisting of wear waterproof gloves and safety glasses should be worn when handling the veterinary medicinal product.

The vaccine strain may be found in the environment for up to 4 weeks.Personnel involved in attending vaccinated chickens should follow general hygiene principles (changing clothes, shoes for visitors) and take particular care in handling litter from recently vaccinated chickens.

4.6 Adverse reactions (frequency and seriousness)

None

4.7 Use during pregnancy, lactation or lay

Laying birds:

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.

Simultaneous use of the vaccine with any other vaccine may decrease and/or delay the immune response to either vaccine. 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

Future layer chicken:

One dose of the vaccine should be administered by eye-drop from 1 day of age or by coarse spray from 5 weeks of age.

Ocular use:

The vaccine should be dissolved in distilled water or alternatively in cool, clean chlorine free water. The appropriate number of vials should be opened and reconstituted. 30 mlof water can be calculated for each 1000 doseof vaccine.

Hold the chicken to be vaccinated with the head tilted to one side. Administer one drop (around 0.03 ml) of dissolved vaccine onto the eye of the bird.

Nebulisation use:

The vaccine should be dissolved in distilled water or alternatively in cool, clean chlorine free water. The appropriate number of vials should be opened and reconstituted. The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens. This will vary according to the age of the chickens being vaccinated and the management system, but 400-500 ml of water can be calculated for each 1000 dose. The vaccine suspension should be spread evenly over the appropriate number of chickens, at a distance of 30-40 cm. Vaccination is recommended in the form of coarse spray assuring a droplet size of 100-150 μm. The spray apparatus should be free from sediments and corrosion traces or disinfectants.

For effective vaccine distribution, make sure that birds are closely confined together, preferably in dimmed light, during spraying.

Depending on housing conditions ventilation should be switched off during and after vaccination in order to avoid turbulences.

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

Ten-fold overdose application of the vaccine strain was shown to be safe for future layers.

4.11 Withdrawal period(s)

Zero days

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines

ATC vet code: QI01AD01

To stimulate active immunity against avian metapneumovirus.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Lactose

Sorbitol

Potassium dihydrogene phosphate

Dipotassium phosphate

Gelatine

Water for injection

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 reconstitution according to directions: 2 hours

6.4 Special precautions for storage

Store and transport refrigerated (2C – 8C).

Do not freeze.

Protect from light

6.5 Nature and composition of immediate packaging

Clear glass vials of hydrolytic glass type I.

1 vial contains 500, 1000, 2000, 2500, 3000, 4000 or 5000 doses. The glass vial is closed with bromobutyl stoppers, and sealed with aluminium caps with plastic tear-off centres.

1, 10 or 20 vials per cardboard 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

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 15052/4086

9. DATE OF FIRST AUTHORISATION

10 October 2016

10. DATE OF REVISION OF THE TEXT

October 2016

Approved: 10/10/2016