Pigs (Piglet 3 - 5 days old).

Cattle (calves on dairy farms).

Piglets:

For the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis.

Calves:

For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in housed calves replacing cows producing milk for human consumption (dairy cows) on farms with a confirmed history of coccidiosis, caused by Eimeria bovis or Eimeria zuernii.

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

Cattle (for environmental reasons):

Do not use in calves weighing more than 80 kg bodyweight.

Do not use in fattening units such as veal or beef calves.

For more details, see Special precautions for use: Other precautions, and Pharmacological particulars: Environmental properties.

As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.

It is recommended to treat all piglets in a litter and all calves in a pen.

Hygienic measures may reduce the risk of porcine and bovine coccidiosis. It is therefore, recommended to improve concomitantly the hygienic conditions in the concerned facility, particularly dryness and cleanliness.

To alter the course of an established clinical coccidial infection in individual animals already showing signs of diarrhoea, additional supportive therapy may be required.

To obtain maximum benefit, animals should be treated before the expected onset of clinical signs, i.e. in the prepatent period.

None known.

Wash any splashes from skin or eyes immediately with water. Wash hands after product administration.

People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product.

The major metabolite of toltrazuril, toltrazuril sulfone (ponazuril), has been shown to be both persistent (half-life > 1 year) and mobile in soil and to be toxic to plants.

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 toltrazuril untreated cattle. Manure from treated calves must be diluted with at least 3 times the weight of manure from toltrazuril untreated cattle before it can be spread onto land.

None known.

Not applicable.

None known. There is no interaction in combination with iron supplementation.

Oral use. Shake well before use.

Piglets:

Individual animal treatment.

Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

Treatment during an outbreak will be of limited value for the individual piglet because of damage to the small intestine having already occurred.

Due to the small volumes required to treat individual piglets, use of dosing equipment with a dose accuracy of 0.1 ml is recommended.

Calves:

Each calf should be treated with a single oral dose of 15 mg toltrazuril/kg body weight corresponding to 3 ml oral suspension per 10 kg body weight.

For the treatment of a group of animals of the same breed and same or similar age, the dosing should be done according to the heaviest animal of this group.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

A threefold overdose is well tolerated without adverse clinical signs.

Meat and offal:

Pigs (piglets): 77 days.

Cattle (calves): 63 days.

Not authorised for use in animals producing milk for human consumption.