EVANT (Canada)

Company: Hipra

Suspension and diluent for oral spray for chickens

Coccidiosis Vaccine, Live Oocysts (Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox, Eimeria tenella)

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 003 391 - 450*; Eimeria maxima, strain 013 230 - 265*; Eimeria mitis, strain 006 345 - 397*; Eimeria praecox, strain 007 345 - 397*; Eimeria tenella, strain 004 325 - 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. HIPRAMUNE T: Adjuvant: Montanide IMS. Excipients: Brilliant Blue (E133), Red AC (E129) and Vanillin.

EVANT Indications

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.

Contraindications

None.

Adverse Reactions

None. If you notice any serious effects or other effects not mentioned in the package leaflet, please inform your veterinary surgeon.

TARGET SPECIES: Chickens.

DOSAGE FOR EACH SPECIES, ROUTE 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.

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 µm 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 HIPRAMUNE T and water, as shown in the following table:

Shake the HIRAMUNE T vial. 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 diluent and water 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 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.

WITHDRAWAL PERIOD: 21 days.

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.

SPECIAL WARNINGS: 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 in laying birds. Do not use in birds in lay and within 2 weeks before the onset 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 post-vaccination 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. Incompatibilities: Do not mix with any other veterinary medicinal product, except with HIPRAMUNE T.

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.

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. 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.

FOR VETERINARY USE ONLY.

Est. Lic. No.: 4.242-E

Distributed in Canada: HIPRA ANIMAL HEALTH CANADA INC, 11 Holland Avenue, suite 605 - Ottawa, Ontario K1Y 4S1 - Tel 613.422.7610

Manufactured by:

LABORATORIOS HIPRA, S.A. Avda. la Selva, 135 . 17170 Amer (Girona) Spain

Tel. (34) 972 43 06 60. Fax (34) 972 43 06 61. hipra@hipra.com

720495-00.1

06-19

CPN: 1905012.0