SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CEVAC TRANSMUNE lyophilisate for suspension for injection with solvent for chicken

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One in ovo dose (0.05 ml) or subcutaneous dose (0.1 ml) contains:

Live attenuated IBD virus, strain Winterfield 2512 at least 0.1 CID₅₀*

Excipients:

BDA (bursal disease antibody) at least 90 VN titre**

Other qs 1 dose

Solvent qs 1 dose

* CID₅₀(Chicken Infective Dose 50%)

** VN titre (virus neutralisation titre)

For a full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension for injection with solvent

Pale brown lyophilisate for reconstitution with a water-clear, colourless solvent provided for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens, 18-day-old embryonated broiler hatching eggs or 1-day-old broiler chickens, from hens vaccinated against IBD.

4.2 Indications for use specifying the target species

For the active immunisation of chickens to reduce mortality, clinical disease, weight loss and acute lesions of bursa of Fabricius associated with infection caused by very virulent Avian Infectious Bursal Disease (IBD) viruses.

The release of the vaccine virus from the complex (and therefore immunisation) is influenced by the natural decline of maternally derived antibodies (MDA), and has been found not to occur until MDA has reached relatively low levels.

The onset of clinical protection depends on the initial MDA level. In vaccinated broilers it is achieved within 1 day after the first signs of vaccine virus effect in the bursa of Fabricius. In practice, this is expected to occur between 21 and 32 days of age in target broiler flocks.

Duration of immunity: up to 42 days of age.

The virulent challenges tests conducted to support the claim were carried out on broilers having an MDA ELISA titre of 6,000 (1-day-old chick).

Field trials carried out showed that vaccine virus replication in the bursa of Fabricius occurs in broilers having at hatch, MDA titre levels of up to 14,000 ELISA units, but the protection of these birds was evaluated only based on serological data and histology of the bursa of Fabricius.

4.3 Contraindications

The use of this vaccine is contraindicated in eggs or in 1-day-old chickens coming from broiler breeder flocks not vaccinated according to an IBD immunisation program. (Refer to section 4.5.)

It is contraindicated to vaccinate 1-day-old chickens hatched from eggs vaccinated in ovo with Cevac Transmune.

4.4 Special warnings for each target species

Chicken embryos on the 18^thday of incubation:

In-ovo injection equipment must be used for in ovo administration. Device(s) used for the reconstitution of the vaccine and for injection should be sterile and free from any residues of chemical disinfectant.

The device should be proven to safely and effectively deliver the appropriate 0.05 ml dose of the vaccine directly into the amniotic cavity or the embryo.

Before every in-ovo application the vaccination technique can be checked by use of a colour solution.The manufacturer's instructions of the device must be strictly followed. For cleaning of the instrument only products approved by the manufacturer may be used.

It is recommended to use 0.4-0.8 mm diameter needles, having length from 25-28 mm and perforation air pressure between 3.5 bar (50 psi) and 5 bar (72 psi).

1-day-old broiler chickens

Automatic syringe may be used for subcutaneous administration. Device(s) used for the reconstitution of the vaccine and for injection should be sterile and free from any residues of chemical disinfectant. The device should be proven to safely and effectively deliver the appropriate 0.1 ml dose of the vaccine. The instructions for use of this device should be strictly followed.

The vaccine must be inoculated under the skin of the neck of the 1-day-old broiler chickens. For cleaning of the automatic syringe, only products approved by the manufacturer may be used.

Residues of chemical disinfectant on the inner surface of devices and equipment used for reconstitution and application can destroy live virus and decrease the efficacy of the vaccine.

4.5 Special precautions for use

Special precautions for use in animals:

Chicken embryos on the 18^thday of incubation

The vaccine contains a strain of "intermediate-plus" virulence. In birds without MDA the inoculation of the vaccine results in significant immunosupression and bursal damage. Therefore, it is not recommended to vaccinate eggs coming from flocks with MDA titre levels in 1-day-old chickens lower than 3,000 ELISA units.

Preliminary survey to be used to estimate MDA level of the chicks: 20, 1-day-old chicks originating from the same breeding flock should be sampled to measure their serological status to IBDV. The results of this sampling will indicate if the MDA level can be expected to be at least 3000 ELISA units in the hatches of the following 4 weeks from this flock, and therefore that they are suitable for Cevac Transmune vaccination. According to results and needs, this survey has to be repeated at different times of the laying period.

The vaccine virus is excreted by vaccinated birds and can spread to susceptible birds and can be detected in unvaccinated birds 4-7 days later.To control the spread of the virus, the immunisation devices used for injection and the hatchery premises should be decontaminated after vaccination.

Chickens from vaccinated eggs should not be mixed with chickens from unvaccinated eggs.

Precautions should be taken regarding between-house spread. Whole site vaccination is recommended.Poultry houses should be decontaminated between batches of chickens.

Satisfactory protection can be achieved only in properly developed embryos at the 18^thday of hatching. It is suggested to candle the eggs to be injected and discard eggs containing dead embryos.

1-day-old broiler chickens

The vaccine contains a strain of "intermediate-plus" virulence. In birds without MDA the inoculation of the vaccine results in significant immunosupression and bursal damage. Therefore, it is not recommended to vaccinate chicks coming from flocks with 1-day-old MDA titre levels lower than 3,000 ELISA units.

Preliminary survey to be used to estimate MDA level of the chicks: 20, 1-day-old chicks originating from the same breeding flock should be sampled to measure their serological status to IBDV. The results of this sampling will indicate if the MDA level can be expected to be at least 3000 ELISA units in the hatches of the following 4 weeks from this flock, and therefore that they are suitable for Cevac Transmune vaccination. According to results and needs, this survey has to be repeated at different times of the laying period.

The vaccine virus is excreted by vaccinated birds and can spread to susceptible birds and can be detected in unvaccinated birds 4-7 days later.To control the spread of the virus, the immunisation devices used for injection and the hatchery premises should be decontaminated after vaccination.

Vaccinated chickens should not be mixed with unvaccinated chickens.

Precautions should be taken regarding between-house spread. Whole site vaccination is recommended.Poultry houses should be decontaminated between batches of chickens.

Satisfactory protection can be achieved only in healthy 1-day-old chickens.

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

Vaccinating personnel should wash and disinfect hands after use.

4.6 Adverse reactions (frequency and seriousness)

In vaccinated chickens, mild to moderate lymphocyte depletion is observed after the vaccine take, which is maximal at around 7 days after vaccine take. After 7 days, this depletion decreases and is followed by lymphocyte repopulation and regeneration of the bursa of Fabricius. In some cases, the replication of the vaccine strain may be prolonged (e.g. due to presence of very high maternal antibody titres in 1 day old chicks), and bursa scores can reach a maximum of 2.8 between 35 and 42 days of age, which does not affect the production parameters of the flock.

4.7 Use during pregnancy, lactation or lay

Do not use in eggs intended for hatching of layers or broiler breeders.

Do not use in 1-day-old chickens intended for layers or broiler 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

In ovo administration

The vaccine is to be administered once at the 18^thday of embryonation using in-ovo equipment The injection volume is 0.05ml per dose for in ovo administration. The vaccine is delivered to the amnion sac or, rarely, into the body of the embryo causing no decrease in hatchability.

Use sterile devices and equipment for reconstitution and for administration of the vaccine.

Subcutaneous administration

The vaccine is to be administered once at 1-day of age, automatic syringe may be used. The injection volume is 0.1ml per dose for subcutaneous administration. The vaccine is delivered under the skin of the neck.

Use sterile devices and equipment for reconstitution and for administration of the vaccine.

Reconstitution of the vaccine

In ovo administration of 0.05 ml per dose:

1. Calculate and prepare the required volume of the reconstituted vaccine as follows:

• a single vial containing 2000 doses of freeze dried component reconstituted in 100 ml solvent,

• a single vial containing 4000 doses of freeze dried component reconstituted in 200 ml solvent,

• a single vial containing 5000 doses of freeze dried component reconstituted in 250 ml solvent,

• two vials, containing 2500 doses of freeze dried component reconstituted in 250 ml solvent,

• two vials, containing 5000 doses of freeze dried component reconstituted in 500 ml solvent.

• four vials, containing 5000 doses of freeze dried component reconstituted in 1000 ml solvent.

2. Draw up 2 ml of the solvent and transfer into the glass vial containing the lyophilised component.

3. Completely dissolve the vaccine by shaking gently and transfer it into the plastic solvent bottle.

4. Rinse the vial with another 2 ml liquid and transfer the rinsing liquid into the plastic solvent bottle.

5. Repeat this rinsing operation.

Administration of the vaccine:

Follow the User Manual instructions for the in-ovo injector equipment.

The reconstituted vaccine should be used within 2 hours.

Subcutaneous administration of 0.1 ml per dose:

1. Calculate and prepare the required volume of the reconstituted vaccine as follows:

• a single vial containing 2000 doses of freeze dried component reconstituted in 200 ml solvent,

• a single vial containing 2500 doses of freeze dried component reconstituted in 250 ml solvent,

• a single vial containing 4000 doses of freeze dried component reconstituted in 400 ml solvent,

• a single vial containing 5000 doses of freeze dried component reconstituted in 500 ml solvent.

• two vials containing 5000 doses of freeze dried component reconstituted in 1000 ml solvent.

2. Draw up 2 ml of the solvent and transfer into the glass vial containing the lyophilised component.

3. Completely dissolve the vaccine by shaking gently and transfer it into the plastic solvent bottle.

4. Rinse the vial with another 2 ml liquid and transfer the rinsing liquid into the plastic solvent bottle.

5. Repeat this rinsing operation.

Administration of the vaccine:

Follow the User Manual instructions for the automatic syringe.

The reconstituted vaccine should be used within 2 hours.

4.10 Overdose (symptoms, emergency procedures, antidotes)

No adverse reactions were observed other than stated in section 4.6, when a 10-fold overdose was administered.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against very virulent infectious bursal disease viruses in broiler chickens from hens vaccinated against IBD.

The vaccine contains the live intermediate plus IBDV strain Winterfield 2512 bound to specific immunoglobulins. Both components form a complex which is administered through vaccination.

The Winterfield 2512 vaccine virus, applied as a non-immune-complex vaccine results in a mean histological lesion score of 2.2 in the bursa of Fabricius, 28 days after vaccination (after oral vaccination of 1-day-old SPF chicken with 10 doses). The severity and duration of lesions is less significant following administration of the immune-complex vaccine.

ATC vet code: QI01AD09

Pharmacotherapeutic group: Live viral vaccines

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lyophilisate: BDA (bursal disease antibody)

cyclodextrin

sucrose

monosodium glutamate

potassium dihydrogen phosphate

dipotassium hydrogen phosphate

Solvent (PBS): sodium chloride

potassium chloride

disodium phosphate dihydrate

potassium dihydrogen phosphate

water for injection

Solvent (Saline solution): sodium chloride

water for Injection

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.

6.3 Shelf life

Shelf life of the lyophilisate as packaged for sale: 2 years.

Shelf life of the solvent (PBS) as packaged for sale: 43 months.

Shelf life of the solvent (Saline solution) as packaged for sale:

- Polyolefin based plastic bags equipped with infusion port, rubber stopper with flip off cap:

33 months.

- Polyolefin based plastic bags equipped with injection port, rubber stopper with flip off cap:

2 years.

Shelf-life after reconstitution (in PBS or in Saline solution) according to directions: 2 hours.

6.4 Special precautions for storage

Lyophilisate: store and transport refrigerated (2 C – 8 C). Protect from light.

Solvent: store below 25C. Do not freeze.

6.5 Nature and composition of immediate packaging

Lyophilisate: Cardboard box with 20 glass vials (Type I) of 10 ml containing 2000, 2500, 4000 or 5000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.

Solvent (PBS): Cardboard box with single, 5 or 20 plastic bottles (LDPE), of 100, 200, 250, 400 or 500 ml solvent, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.

Solvent (Saline solution):

Polyolefin based plastic bags equipped with infusion port, rubber stopper with flip off cap: 500 ml, 1000 ml, 5 x 500 ml, 5 x 1000 ml.

Polyolefin based plastic bags equipped with injection port, rubber stopper with flip off cap: 250 ml, 500 ml, 1000 ml, 5 x 250 ml, 5 x 500 ml, 5 x 1000 ml.

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

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

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 15052/4030

9. DATE OF FIRST AUTHORISATION

20 October 2006

10. DATE OF REVISION OF THE TEXT

March 2016

Approved: 07/03/2016