EVANT suspension and solvent for oral spray for chickens – patient leaflet, side effects, dosage

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

LABORATORIOS HIPRA, S.A.

Avda. la Selva 135

17170 Amer (Girona)

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

EVANT suspension and solvent for oral spray for chickens.

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

EVANT:

Active substances:

Each dose (0.007 ml) of undiluted vaccine contains:

Eimeria acervulina, strain 003.....................................332 - 450*

Eimeria maxima, strain 013 .........................................196 - 265*

Eimeria mitis, strain 006 ..............................................293 - 397*

Eimeria praecox, strain 007 .........................................293 - 397*

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.

Adjuvant and excipients:

Suspension: White turbid suspension.

Solvent: Dark brownish solution.

4. INDICATION(S)

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

Onset of immunity: 14 days post-vaccination.

Duration of immunity: 63 days post-vaccination in an environment that permits oocysts recycling.

5. CONTRAINDICATIONS

None.

6. ADVERSE REACTIONS

None.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Chickens.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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

Oral use.

The method of administration is by coarse spray.

9. ADVICE ON CORRECT ADMINISTRATION

The method of administration is by coarse spray by using a suitable device (volume delivered:

28 ml/100 chicks, droplet size: 200 - 250 ^m and working pressure: 1.5 to 3 bars). Before starting to prepare the spray solution, ensure there is a clean container with sufficient capacity for preparing the diluted vaccine suspension available. Dilute the vaccine with the relevant volumes of the solvent (HIPRAMUNE T or HIPRACELL) and water, as shown in the following table:

DOSES WATER VACCINE Solvent TOTAL

Shake the solvent vial (HIPRAMUNE T or HIPRACELL). Dilute the contents of the vial with clean, room temperature water into an appropriate container.

Shake the vaccine (EVANT) vial and dilute the contents of it into the solvent and water solution. A purplish suspension is obtained after dilution.

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 the vaccination, 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 into 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.

10. WITHDRAWAL PERIOD(S)

Zero days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C - 8 °C). Do not freeze.

Shelf life after dilution according to directions: 10 hours.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.

12. SPECIAL WARNING(S)

Special warnings for each target species:

The vaccine will not protect species other than chickens against coccidiosis and is only effective against the Eimeria species indicated. This product is intended for the vaccination of short-lived chickens only. No data is available on protection of longer-lived birds such as future layers/breeders. Special precautions for use in animals:

Vaccinate healthy chickens only.

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

In order to reduce field infections, it is recommended that all litter should be removed and facilities and related equipment in contact with vaccinated chickens should be cleaned between production cycles.

Lay:

The safety of the veterinary medicinal product has not been established during lay. Do not use in birds in lay or in breeding birds, or within 4 weeks before the start of the laying period.

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

Wash and disinfect hands and equipment after use.

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 the vaccination of chickens with this product otherwise the correct replication of the vaccine oocysts, and consequently the development of a solid immunity, could be hindered. Additionally, the duration of immunity depends on an environment that permits recycling of oocysts, therefore a decision to use any anticoccidial substances in the period after 3 weeks postvaccination should be made taking into account the potential negative impact on the duration of immunity of this product.

Overdose (symptoms, emergency procedures, antidotes):

After the administration of a severe overdose (10-fold), mild, transient, clinical signs of coccidiosis were commonly observed without any consequences on the final performance.

Major incompatibilities:

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

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency (http: //www.ema.europa.eu/).

15. OTHER INFORMATION

Pack sizes:

Cardboard box with one vial of EVANT containing 7 ml (1,000 doses) and one vial of

HIPRAMUNE T containing 50 ml.

Cardboard box with one vial of EVANT containing 35 ml (5,000 doses) and one vial of

HIPRAMUNE T containing 250 ml.

Cardboard box with one vial of EVANT containing 70 ml (10,000 doses) and one vial of

HIPRAMUNE T containing 500 ml.

Cardboard box with one vial of EVANT containing 7 ml (1,000 doses) and one vial of HIPRACELL containing 50 ml.

Cardboard box with one vial of EVANT containing 35 ml (5,000 doses) and one vial of HIPRACELL containing 250 ml.

Cardboard box with one vial of EVANT containing 70 ml (10,000 doses) and one vial of

HIPRACELL containing 500 ml.

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

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