1. NAME OF THE VETERINARY MEDICINAL PRODUCT

EVALON suspension and solvent for oral spray for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (0.007 ml) of undiluted vaccine contains:

Active substances:

Eimeria acervulina, strain 003	332 – 450*
Eimeria brunetti, strain 034	213 – 288*
Eimeria maxima, strain 013	196 – 265*
Eimeria necatrix, strain 033	340 – 460*
Eimeria tenella, strain 004	276 – 374*

* Number of sporulated oocysts derived from precocious attenuated lines of coccidia, according to in vitro procedures of the manufacturer at the time of blending.

Adjuvants:

Montanide IMS

Excipients:

Qualitative composition of excipients and other constituents

EVALON (suspension):

Potassium chloride

Disodium phosphate dodecahydrate

Potassium dihydrogen phosphate

Sodium chloride

HIPRAMUNE T (solvent):

Brilliant Blue (E 133)

Red AC (E 129)

Vanillin

Montanide IMS

Suspension: white turbid suspension.

Solvent: dark brownish solution.

3. CLINICAL INFORMATION

3.1 Target species

Chickens.

3.2 Indications for use for each target species

For active immunisation of chicks from 1 day of age to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.

Onset of immunity: 3 weeks post-vaccination.

Duration of immunity: 60 weeks post-vaccination in an environment that permits oocysts recycling.

3.3 Contraindications

None.

3.4 Special warnings

Vaccinate healthy animals only.

The vaccine will not protect species other than chickens against coccidiosis and is only effective against the Eimeria species indicated.

It is normal to find vaccinal oocysts in the intestine or litter of vaccinated flocks. Generally, the number is higher the first week post-vaccination and lower once the flock has achieved a proper protection.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Chickens must be strictly floor-reared in the first 3 weeks after vaccination.

It is recommended that litter should be removed and facilities and material cleaned between production cycles to reduce field infections.

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

Wash and disinfect hands and equipment after use.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Chickens:

None.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Laying birds:

The safety of the veterinary medicinal product has not been established during lay. Do not use in birds in lay and within 2 weeks before the onset of the laying period.

3.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product. A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

No anticoccidial substances or other agents having anticoccidial activity via feed or water should be used for at least 3 weeks following vaccination of the chickens. The correct replication of the vaccine oocysts and consequently, the development of a solid immunity could be hindered. Additionally, the enhancement of protection produced by oocyst re-infections would also be limited.

3.9 Administration routes and dosage

Oral use.

The method of administration is by coarse spray.

Vaccination schedule:

One dose of vaccine (0.007 ml) from 1 day of age.

Administration route:

The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml / 100 chicks, droplet size: 200 – 250 µm and working pressure: 2 to 3 bars). Before starting the preparation, make certain to have a clean container available with sufficient capacity for preparing the diluted vaccine suspension. Dilute the vaccine with the corresponding volumes:

Doses	Water	Vaccine	Solvent	Total
1 000	223 ml	7 ml	50 ml	280 ml
5 000	1 115 ml	35 ml	250 ml	1 400 ml
10 000	2 230 ml	70 ml	500 ml	2 800 ml

Shake the solvent vial. Dilute the content of the vial with clean room temperature water into an appropriate container.

Shake the vaccine vial and dilute the content into the previous solution.

Fill the reservoir of the spraying device with all the vaccine suspension prepared.

Maintain the diluted vaccine suspension in continuous homogenisation by using a magnetic stirrer while the vaccine is being administered via coarse spray to the chicks.

To improve the uniformity of thevaccination maintain the chicks inside the transportation box for at least 1 hour in order to let them ingest all the vaccine droplets.

After this time, place the chicks carefully in the litter and continue with regular management practices.

The device should be cleaned after each use. See the manufacturer’s instructions to ensure proper disinfection and maintenance of the device.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Severe overdose (10 - fold) may result in a temporary reduction in daily live weight gain within the first week without any consequences on the final performances.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Zero days.

4. IMMUNOLOGICAL INFORMATION

4.1 ATCvet code: QI01AN01.

To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

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

5.2 Shelf life

EVALON (vaccine):

Shelf life of the veterinary medicinal product as packaged for sale: 10 months.

Shelf life after first opening the immediate packaging: use immediately. Shelf life after dilution according to directions: 10 hours.

HIPRAMUNE T (solvent):

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

5.3 Special precautions for storage

Store and transport refrigerated (2 ºC– 8 ºC).

Do not freeze.

5.4 Nature and composition of immediate packaging

EVALON (vaccine):

10 ml, 50 ml or 100 ml type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1 000, 5 000 and 10 000 doses) closed with type I polymeric elastomer closures and aluminium caps.

HIPRAMUNE T (solvent):

Polypropylene (PP) vials containing 50 ml, 250 ml and 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.

Pack sizes:

Cardboard box with one vial of 1 000 doses (7 ml) and one vial with 50 ml of solvent.

Cardboard box with one vial of 5 000 doses (35 ml) and one vial with 250 ml of solvent.

Cardboard box with one vial of 10 000 doses (70 ml) and one vial with 500 ml of solvent.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

LABORATORIOS HIPRA, S.A.

7. MARKETING AUTHORISATION NUMBER(S)

EU/2/16/194/001–003

8. DATE OF FIRST AUTHORISATION

Date of first authorisation: 18/04/2016

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

{DD/MM/YYYY}

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).