NAME OF THE VETERINARY MEDICINAL PRODUCT

LIVACOX^® T peroral suspension
Trivalent live attenuated coccidiosis vaccine for domestic poultry (Gallus gallus domesticus)

STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Active substances
One dose contains coccidian oocysts of:

Excipients
Chloramine B, water

Whitish suspension.

INDICATIONS

For immunization of domestic poultry, specifically commercial broiler chickens, against coccidiosis caused by E. acervulina, E. maxima and E. tenella. Immunity develops 10 - 14 days after vaccination and remains active during the broiler’s whole life.

CONTRAINDICATIONS

Contact with any substances having anticoccidial activity, after vaccination, may reduce the period of effective protection during the course of the bird’s life. Feed given to chickens shall not include any anticoccidials and sulphonamides from 2 days before until 14 days after vaccination.

ADVERSE REACTIONS

1 - 2 weeks after vaccination a temporary impairment of feed conversion may be recorded.

TARGET SPECIES

Domestic poultry (Gallus gallus domesticus), chickens 1 - 10 days old.

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Shake well before use.
Vaccinate only birds in good health.

1 mL of the vaccine = 100 doses

Drinking Water:
A single dose of the vaccine is given one-time to chickens 1-10 days old. Early vaccination in the bird’s life is recommended.
The water consumption for vaccination can be set approximately using the following formula:
1 litre of water / 1 day of chicken age / 1,000 chickens.
If dosing devices are used the vaccine shall be first pre-diluted and then added to drinking water proportionally with the dosing machine.

The birds shall consume the vaccinated water within 2 hours.

The dilution is to be adapted to the actual water consumption of the birds (depending on age, breed, sex and local environmental conditions) and customers should consider field experience and requirements for vaccination under local conditions.

Example:
To vaccinate 10,000 chickens 4-days-old the vaccine should be administered in 40 litres of drinking water. The required 10,000 doses are contained in 100 mL of vaccine. If dosing equipment is used then the vaccine must be pre-diluted to 400 mL, which shall then be diluted further with drinking water in a 1:100 ratio by the dosing device so that the final volume of vaccinated water is 40 litres.

Coarse - Spray application:
Consult your spray device selection with the vaccine producer!
The vaccine shall be diluted with drinking water containing a food dye (to enable visual control of the application) and sprayed on 1-day-old chickens in the crate. The chickens should remain in the crate for at least 3 hours.

Recommended dilution:
The total volume of fluid to be sprayed (1 crate / 100 chickens) is 20 mL, i.e. the vaccination dose is contained in 20 mL of solution (1 mL of vaccine (100 doses) + 19 mL of drinking water with dye).
The chickens in every crate shall be sprayed with 1 mL of vaccine always for 100 chickens even if the crate contains less than 100 chickens.

ADVICE ON CORRECT ADMINISTRATION

Ensure access to droppings for a minimum of 10 days.
Pre-dilute vaccine when using dosing equipment with drinking water administration.

WITHDRAWAL PERIOD

None.

SPECIAL STORAGE PRECAUTIONS

Keep out of reach and sight of children.
Store in dry and dark place at +2 to +8 °C.
Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life after dilution according to directions: use immediately.

SPECIAL WARNINGS

Special warnings for each target species:
The preparation is ineffective against coccidiosis in other animal species. Causal ingestion by other animal species does not expose them to any risk.

Special precautions for use in animals:
Dead birds sent for pathological and anatomical examination shall be accompanied with a document confirming that they were vaccinated against coccidiosis, to avoid any misdiagnosis.
Avoid using feed containing any anticoccidials for the whole life of the flock, and administration of sulphonamides between 2 days before and 14 days after the vaccination.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
It is prohibited to eat, drink and smoke when handling the preparation. It is recommended to wear gloves. The vaccine contains Chloramine B which may irritate skin or respiratory organs of sensitive persons.

Interactions with other medicinal products and other forms of interactions:
No interactions other than specified in the Contraindications section were observed.
No information on the vaccine’s safety and efficacy when used together with another vaccine is available.

Overdose (symptoms, emergency procedures, antidotes):
Tenfold overdosing does not cause any negative symptoms.

Incompatibilities:
Avoid using the preparation together with anticoccidials including sulphonamides.

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

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

OTHER INFORMATION

Packaging
1 x 10 mL (1,000 doses)
1 x 50 mL (5,000 doses).

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE:

BIOPHARM, Research Institute of Biopharmacy and Veterinary Drugs
Pohori-Chotoun 90
254 49 Jilove u Prahy
Czech Republic
www.livacox.com