Target species
Chickens (broilers, pullets and breeders) and turkeys.
Indications for use, specifying the target species
For the treatment of coccidiosis in chickens and turkeys, caused by infections with various species of Eimeria:
Chickens: E. acervulina, E. brunetti, E. maxima, E. mitis, E. necatrix, E. tenella.
Turkeys: E. adenoides and E. meleagrimitis.
Contraindications
Do not use in animals with hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Good hygiene can reduce the risk of coccidiosis. It is therefore recommended any deficiencies in husbandry should be addressed in addition to treatment. Poultry houses should be kept clean and dry.
It is recommended to treat all animals in a pen. For best results, treatment should be initiated before the clinical signs of disease have spread throughout the whole group.
Special precautions for use
Special precautions for use in animals
As with any anticoccidials, frequent and prolonged use of an antiprotozoal of the same class may result in the development of resistances. It is important to keep to the recommended dose in order to minimise the risk of resistance.
If resistance is present it should be considered to use another antiprotozoal from another class/mechanism of action.
This VMP should not be used together with feed additives/or other veterinary medicinal products that might interfere with the efficacy of the product, like "coccidiostats" and "histomonostats".
For best results, treatment should be initiated before the clinical signs of disease have spread throughout the whole group.
The veterinary medicinal product is a strongly alkaline solution and should not be administered undiluted.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to toltrazuril should avoid contact with the veterinary medicinal product.
The veterinary medicinal product is an alkaline solution.
Wear synthetic rubber gloves when handling the product.
Contact with skin and mucous membranes should be avoided.
In case of direct contact with the eyes or skin, wash immediately and thoroughly with water.
Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Do not eat, drink or smoke during use.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Not applicable, see Withdrawal periods.
Interaction with other medicinal products and other forms of interaction
Combination of the product with antibiotics may result in reduced water intake in turkeys. The concomitant administration of other substances to the drinking water should be avoided.
Amounts to be administered and administration route
For oral administration via the drinking water.
In order to ensure administration of a correct dose, the total weight of the treated animals and the daily water consumption must be accurately calculated.
The dose is 7 mg toltrazuril per kg body weight (bw) per day (= 0.28 ml [product] per kg bw per day). Treatment is carried out on two consecutive days.
The medicinal product should be administered continuously over 24 hours per day for 2 consecutive days.
In case an automatic dose dispenser is used the medicinal product should be administered for one period of 8 hours per day for 2 consecutive days.
Medicated drinking water should be refreshed every 24 hours.
The dosage should be based on the current, actual drinking water intake of the animals, because this varies depending on the animal species, on the age, state of health and intended use of the animals, and depending on the housing conditions (e.g. different ambient temperature, different lighting regime).
In the case of continuous treatment over 24 hours, the volume of the product to be mixed into the drinking water for the animals to be treated is calculated according to the following formula:
Volume of the product required per litre drinking water:
Total volume of the product required per day (24 h):
The calculated volume (x ml [product] per litre) must be multiplied by the total consumption of drinking water (l) per day (24 h).
0.28 ml [product] per kg bw per day | x | Average bw (kg) of the animals to be treated | = | x ml [product] per litre drinking water |
Average drinking water intake in litres over 24 hours per animal |
In the case of treatment for a period of 8 hours per day, the volume of the product to be mixed into the drinking water for the animals to be treated is calculated according to the following formula:
Volume of the product required per litre drinking water:
Total volume of the product required for a treatment period of 8 hours:
0.28 ml [product] per kg bw per day | x | Average bw (kg) of the animals to be treated | = | y ml [product] per litre drinking water |
Average drinking water intake in litres over 8 hours per animal |
The calculated volume (y ml [product] per litre) must be multiplied by the total consumption of drinking water (l) per 8-hour period.
The appropriate volume of solution must be added daily to the drinking water while stirring.
If volumes of between 1 and 4 ml product are added per litre drinking water, solubility is guaranteed over the period of treatment.
In order to ensure that all the animals drink water evenly, sufficient space must be made available at the waterer. Free-range animals must be kept indoors during treatment.
After the end of the treatment, the watering system must be cleaned in an appropriate manner in order to prevent any exposure to residual subtherapeutic doses, particularly if liable to promote the development of resistance.
Predilution and the administration through a dosing pump (proportioner) are not recommended. Use preferably a bulk tank.
Overdose (symptoms, emergency procedures, antidotes), if necessary
A reduction in drinking water intake may be the first sign of an overdose. This is observed only after an overdose with more than 10 times the recommended dose.
Withdrawal periods
Chickens:
Meat and offal: 16 days
Turkeys:
Meat and offal: 16 days
Eggs: Not authorised for use in laying birds producing eggs for human consumption. Do not use within 4 weeks of onset of laying.