Dozuril 25 mg/ml solution for use in drinking water for chickens

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains:
Active substance
Toltrazuril 25.0 mg

PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear colourless to brown solution

Target species:
Chickens ( pullets and breeders)

Indications for use, specifying the target species
Treatment of coccidiosis in pullets and broiler breeders.

Contra-indications
None.

Special warnings, for each target species
Good hygiene can reduce the risk of coccidiosis. It is therefore recommended that any deficiencies in husbandry should be addressed in addition to treatment. Poultry houses should be kept clean and dry.
It is recommended that all individuals in the group are treated.
For best results, treatment should be initiated before the clinical signs of disease have spread throughout the whole group.

Special precautions for use
i) Special precautions for use in animals
As with all anticoccidials, prolonged use may result in the development of resistant strains.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid skin and eye contact with the product.
Wear personal protective clothing, including synthetic rubber gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and any exposed skin after use.
Do not eat, drink or smoke whilst using the product.

iii) Other precautions
None

Adverse reactions (frequency and seriousness)
Not known.

Use during pregnancy and lactation or lay
None.

Interactions with other medicinal products and other form of interaction
None known.

Amounts to be administered and administration route
Administration: Orally via the drinking water.
Dosage: 7 mg per kg of bodyweight per day for 2 consecutive days, orally, this corresponds to 28 ml of oral solution per 100 kg of bodyweight per day or 1.4 ml of the product per litre of drinking water, based on a water consumption of 1 litre per 5 kg bodyweight.
This medicinal product should be administered either continuously over 48 hours, or for one 8 hour period per day  for 2 consecutive days.
The total weight of the treated animals and the daily water consumption must be accurately calculated.
The consumption of water may vary depending in particular on the clinical condition, the ambient temperature, the lighting program, the drinking system used, the age and breed. If the water consumption is more or less than the above standards, the concentration of the medicinal product in the drinking water should be adjusted accordingly.
Use appropriate and properly calibrated dosing equipment. Medicated water should be the only drinking source.
The medicated water is only usable for 24 hours and should be made freshly every day.
Dilutions more concentrated than 3:1,000 (3 ml of product to 1 litre drinking water) may result in precipitation. Predilution  and the administration through a dosing pump (proportioner) are not recommended. Use preferably a bulk tank.

Overdose (symptoms, emergency procedures, antidotes)
The first signs of intolerance such as reduced water intake were observed beyond 5 times the recommended dose.

Withdrawal period
Meat and offal: 16 days.
Eggs: Not authorized for use in laying birds producing eggs for human consumption.

Incompatibilities
Do not mix with other veterinary medicinal products.

Shelf-Life
Shelf-life of the veterinary medicinal product as packaged for sale: 4 years.
Shelf-life after dilution  according to directions: 24 hours.
Shelf-life after first opening the immediate packaging: 3 months.

Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.

Nature and composition of the immediate packaging
1 litre high-density polyethylene bottles with high-density polyethylene screw cap and removable polyethylene sealing disk .

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.