SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CEVAC IBird lyophilisate for suspension for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Live, attenuated infectious bronchitis (IB) virus, strain 1/96,

min. 2.8 log10 EID50* /dose

max. 4.3 log10 EID50* /dose

Excipients: q.s. 1 dose

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

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Yellowish white, lyophilisate for suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Chicken (broilers and future layers)

4.2 Indications for use, specifying the target species

For the active immunization of broiler chickens, and future layer chickens in order to reduce the detrimental effect on the ciliary activity resulting from the infection, which may be manifested in respiratory clinical signs. Protection was demonstrated by challenge with the 793/B strain, which is a representative strain of the 793/B group.

Onset of immunity is 3 weeks after one administration of the vaccine.

Duration of immunity is 6 weeks after the first vaccination.

4.3 Contraindications

Do not vaccinate unhealthy animals.

4.4 Special warnings

None

4.5 Special precautions for use

Special precautions for use in animals

All chickens on a site should be vaccinated at the same time and within the same premises.

The vaccine strain may spread to non-vaccinated chickens. Vaccinated chickens may excrete the vaccine strain for up to 28 days or longer following vaccination.

Care should be taken to avoid spread of the vaccine virus from vaccinated chickens to pheasants and turkeys.

Cevac IBird is intended to protect chickens against respiratory disease caused by variant strains of infectious bronchitis virus belonging to the 793/B group and should not be used as a replacement for other IBV vaccines.

The product should not be used without a diagnosis being made that infection is caused by a strain of the 793/B group and after it has been established that the IBV virus group 793/B is epidemiologically relevant in this area. Care should be taken to avoid the introduction of the variant group into an area where it is not present.

Good animal husbandry, hygiene practices (e.g. cleaning and disinfection procedures, changing clothing and shoes for visitors) can effectively help to protect the environment.

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

The vials may be opened under water to avoid aerosol forming.

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

4.6 Adverse reactions (frequency and seriousness)

After vaccination with the product, no notable clinical signs were observed. In some cases slight tracheal rales were observed which may persist for at least 10 days.

4.7 Use during pregnancy, lactation or lay

Future layer chickens:

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

Broiler chickens

One dose of the vaccine should be administered by nebulisation use with coarse spray from 1 day of age. Older chickens can also be vaccinated by coarse spray.

Nebulisation method: The vaccine should preferably be dissolved in distilled water or alternatively in cool, clean chlorine free water. The appropriate number of vials should be opened under water. 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 at least 250 ml of water per 1000 doses is suggested. The vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30-40 cm using a coarse spray providing droplet sizes in a range of 137-153 µm. The nebulisation use via coarse spray application is preferable when the chickens are sitting together in dim light. 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 during spraying.

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

Future layer chickens

One dose of the vaccine should be administered by drinking water from 10 days of age. In order to maintain immunity, chickens may be revaccinated every 3 weeks. However, donot use in birds in lay and within 4 weeks before the onset of the laying period.No studies were done to show protection during the laying period.

The vaccine should be dissolved in the drinking water. The amount of water should be calculated based on the average water consumption of the flock in the previous 4 days before vaccination.Calculate the amount of water needed, so that the vaccine is consumed within 2 hours. This amount should be approximately 30% of the daily intake.

Medication, disinfectants and chlorine must be removed from the drinking water 48 hours before vaccination.

Water should be withheld prior to vaccination to make the chickens thirsty. The period for water withdrawal is dependent on the climate. Water withholding should be kept as short as possible with a minimum of 30 minutes.

The vials should be opened under water. Use cool, clean water to dissolve the vaccine. For administration of the vaccine, as a general rule, dissolve 1000 doses in one litre per age in days up to a maximum volume of 20 litres per 1000 doses, or in hot weather, the quantity of water may be increased up to 40 litres per 1000 doses.

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

No side effects other than those listed in paragraph “Adverse reactions” have been observed following the administration of ten times the recommended dose of vaccine.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Live attenuated viral vaccine, ATCvet code: QI01AD07

To stimulate active immunity in chickens against avian infectious bronchitis virus, strain 1/96 belonging to the 793/B virus group.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

gelatine

hydroxypropylbetadex

sucrose

monosodium glutamate

potassium dihydrogene phosphate

dipotassium hydrogene phosphate

purified water

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: 12 months

Shelf life after dilution or 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

Freeze-dried component: 3 and 10 ml clear glass vials of hydrolytic glass type I, presented in a cardboard box with 1, 10 or 20 vials/ box.

1 vial contains 500, 1000, 2500 or 5000 doses.

The glass vial of the freeze-dried component is closed with bromobutyl stoppers, and sealed with aluminium caps with plastic tear-off centres.

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 15052/4060

9. DATE OF FIRST AUTHORISATION

16 August 2013

10. DATE OF REVISION OF THE TEXT

August 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 16/08/2013