EVANOVO (Canada)

Company: Hipra

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

Suspension and diluent for suspension for injection for chickens.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):

Active substances:

Each dose (0.006 ml) of undiluted vaccine contains:

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

Suspension: white turbid suspension. Diluent: clear colourless solution.

INDICATION(S):

For the active immunisation of chickens to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima and Eimeria praecox, and for the reduction of clinical signs, intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria tenella.

Onset of immunity: 21 days of age. Duration of immunity: 63 days of age in an environment that permits oocysts recycling.

Contraindications

None.

Adverse Reactions

None known. If you notice any side effects, even those not already listed in the package leaflet or you think that the medicine has not worked, please inform your veterinarian.

TARGET SPECIES: Chicken embryonated eggs.

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

In ovo administration. Administer one single injection of 0.05 ml or 0.1 ml of the diluted vaccine suspension into each chicken egg at 18 days of embryonation.

ADVICE ON CORRECT ADMINISTRATION:

An automated egg injection machine can be used. In ovo equipment should be previously calibrated to ensure that a 0.05 ml or 0.1 ml dose is applied. The instructions for the calibration and use of the equipment should be strictly followed, in order to deliver the appropriate dose in the amnion of the embryonated egg.

For the dilution and administration of the vaccine, use sterile equipment free from any residues of chemical disinfectants.

Prepare the required volume of the vaccine as per the examples provided in the tables below, showing different dilution possibilities, according to different presentations:

Dilutions for in ovo administration (0.05 ml per dose):

Dilutions for in ovo administration (0.1 ml per dose):

Dilution of the vaccine:

1. Withdraw from the HIPRAHATCH diluent bag the same millilitres that are going to be injected of vaccine (EVANOVO), as stated in the example tables above.

2. Shake the vaccine vial/s and inject the content of it/them into the HIPRAHATCH diluent bag. Mix the contents of the bag by gentle agitation until the contents are completely diluted.

3. The diluted vaccine is a white suspension, which should be used within 10 hours after dilution. Mix the bag by gentle agitation every 30 minutes during vaccination.

The vaccine must be injected into the amniotic sac of 18-day-old embryonated chicken eggs.

For simultaneous use with GUMBOHATCH, the mixed administration of EVANOVO and GUMBOHATCH should only be used when vaccinating in ovo 18-day-old embryonated eggs.

The following instructions should be used:

1.1 Taking into account the HIPRAHATCH diluent bag volume, prepare the EVANOVO vaccine as described above.

1.2 Once the EVANOVO vaccine has been prepared, consider the bag volume to prepare enough GUMBOHATCH doses for the bag volume.

1.3 In each GUMBOHATCH vial to be used, insert 4 ml of the EVANOVO diluted vaccinal suspension prepared in section 1.1.

1.4 Once the lyophilized tablet is properly resuspended, introduce the volumes of the different GUMBOHATCH vials into the vaccinal bag.

1.5 Homogenize by moving the bag volume with the hands until having an even homogenate solution.

1.6 Vaccinate using the vaccinal bag with the mixed vaccines within a period of 2 hours via in ovo. Mix the bag by gentle agitation every 30 minutes during vaccination.

Prepare the required volume of each vaccine as per the examples provided in the table below, showing different mixing possibilities, according to different presentations for in ovo administration (0.05 ml per dose):

The vaccine should not be used in case its appearance is different from a white turbid suspension.

WITHDRAWAL PERIOD(S): 21 days.

SPECIAL STORAGE PRECAUTIONS:

Keep out of the sight and reach of children. EVANOVO suspension: Store and transport refrigerated (2 °C - 8 °C). Do not freeze. Protect from light. HIPRAHATCH diluent: Do not store above 25 °C. Shelf life after dilution according to directions: 10 hours. Shelf life after mixing with GUMBOHATCH: 2 hours. Do not use this veterinary medicinal product after the expiry date, which is stated on the label and the carton.

SPECIAL WARNING(S):

Special warnings for each target species

The vaccine will not protect species other than chickens against coccidiosis.

Special precautions for use in animals

Vaccinate healthy embryos 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.

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

Wash and disinfect hands and equipment after use.

In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with GUMBOHATCH prior to use and administered simultaneously in ovo. The product information of GUMBOHATCH should be consulted before administration of the mixed products. The mixed administration of GUMBOHATCH and EVANOVO should only be used when vaccinating 18-day-old embryonated eggs. For mixed use, the onset and duration of immunity of the Eimeria species included in the EVANOVO vaccine have been demonstrated to be equivalent to those determined for EVANOVO when used alone. No information is available on the safety and efficacy of this vaccine when used with any other vaccine except the product mentioned above. A decision to use this vaccine before or after any other vaccine 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 hatching of chickens from vaccinated eggs 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 of age should be made taking into account the potential negative impact on the duration of immunity of this product.

Overdose (symptoms, emergency procedures, antidotes)

No adverse reactions were observed after the administration of a 10-fold overdose.

Incompatibilities

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

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 EVANOVO suspension containing 6 ml (1,000 doses).

Cardboard box with one vial of EVANOVO suspension containing 12 ml (2,000 doses).

Cardboard box with one vial of EVANOVO suspension containing 24 ml (4,000 doses).

Cardboard box with one vial of EVANOVO suspension containing 30 ml (5,000 doses).

Cardboard box with one vial of EVANOVO suspension containing 48 ml (8,000 doses).

Cardboard box with one vial of EVANOVO suspension containing 60 ml (10,000 doses).

Cardboard box with 10 bags containing 200 ml of HIPRAHATCH diluent.

Cardboard box with 10 bags containing 400 ml of HIPRAHATCH diluent.

Cardboard box with 10 bags containing 500 ml of HIPRAHATCH diluent.

Cardboard box with 10 bags containing 800 ml of HIPRAHATCH diluent.

Cardboard box with 10 bags containing 1,000 ml of HIPRAHATCH diluent.

Not all pack sizes may be marketed.

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

735235-20.2

12-23

CPN: 1905015.0