Suspension and solvent for oral spray.

Evalon:

Each dose (0.007 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.

HIPRAMUNE T (solvent):
Adjuvant:
Montanide IMS
Excipients:
Brilliant Blue (E133)
Red AC (E129)
Vanillin

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.

For oral use.

The method of administration is by coarse spray.

Vaccination dosing 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:

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 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 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.

Do not use in birds in lay and within 2 weeks before the onset of the laying period.

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

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

Chickens must be strictly floor-reared in the first 3 weeks after vaccination.
Vaccinate healthy chickens only.

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

Wash and disinfect hands and equipment after use.

None known.

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.

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.

Poultry meat and eggs: zero days

For animal treatment only. Keep out of the sight and reach of children.

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

Do not freeze.

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.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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.

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

E-mail: hipra@hipra.com

Nil.

UK (NI): EU/2/16/194/001–003

UK (GB): Vm 17533/5003