Contraindications
Do not use in cases of known hypersensitivity to the active substance or any of the excipients.
Cattle (for environmental reasons):
•Do not use in veal calves.
•Do not use in dairy calves weighing more than 80 kg body weight.
•Do not use in suckler calves weighing more than 150 kg bodyweight.
•Do not use in bull beef calves less than 3 months old or weighing more than 150 kg in bodyweight.
Special warnings for each target species
As with any antiparasiticides, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance. If resistance is present it should be considered to use another antiprotozoal from another class and with a different mechanism of action.
It is recommended to treat all animals (calves & lambs) in a pen. Hygienic measures may reduce the risk of coccidiosis. It is therefore, recommended to improve concomitantly the hygienic conditions in the concerned facility, particularly dryness and cleanliness. To obtain maximum benefit, animals should be treated before the expected onset of clinical signs, i.e. in the prepatent period. Treatment during an outbreak will be of limited value for the individual animal, because of damage to the small intestine having already occurred. To alter the course of an established clinical coccidial infection, in individual animals already showing signs of diarrhoea, additional supportive therapy may be required.
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product.
Do not eat, drink or smoke while using the product.
Avoid skin and eye contact with the product.
Wash any splashes from skin or eyes immediately with water.
Special precautions for the protection of the environment:
The major metabolite of toltrazuril, toltrazuril sulfone (ponazuril), has been shown to be both very persistent (half-life ca. 1 year) and mobile in soil and to be toxic to plants including crop species. For the mentioned environmental reasons the following restrictions on the use apply:
Cattle:
Veal calves - Not to be used in veal calves.
Dairy calves - Do not administer to dairy calves weighing more than 80 kg bodyweight. In order to prevent any adverse effects on plants and possible contamination of groundwater, manure from treated calves must not be spread onto land without dilution with manure from untreated cows. Manure from treated calves must be diluted with at least 3 times the weight of manure from mature cows before it can be spread onto land.
Suckler calves - Do not administer to suckler calves weighing more than 150 kg bodyweight.
Bull beef calves - Not to be used to treat bull beef calves less than 3 months old. Do not administer to bull beef calves weighing more than 150 kg bodyweight.
Sheep: Lambs kept throughout the whole life span indoors under an intensive rearing system must not be treated beyond the age of 6 weeks or body weight of more than 20 kg at treatment. Manure from treated animals should only be applied to the same piece of land every third year. Lambs kept throughout the whole life span indoors under an intensive rearing system must not be treated beyond the age of 6 weeks or body weight of more than 20 kg at treatment. Manure from treated animals should only be applied to the same piece of land every third year.
Pigs: None.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No signs of intolerance were reported in healthy piglets and calves after oral administration of threefold overdose. In lambs, no signs of overdose have been observed with threefold overdose at a single treatment and twofold overdose at treatment on two consecutive days.
Adverse Reaction: None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Interaction with other medicinal products and other forms of interaction: None known.
In pigs there is no interaction in combination with iron supplementation.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Withdrawal Periods
Pigs:
Meat & Offal: 77 days.
Cattle:
Meat & Offal: 63 days.
Milk: Not authorised for use in lactating animals producing milk for human consumption.
Sheep:
Meat & Offal: 42 days.
Milk: Not authorised for use in lactating sheep producing milk for human consumption.