Target species Pig (piglets), Calves (on dairy farms – see section 4.3) and Sheep (lambs) 4.2 Indications for use, specifying the target species 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. Lambs: For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in lambs on farms with a confirmed history of coccidiosis caused by Eimeria crandallis and Eimeria ovinoidalis. 4.3 Contraindications 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 sections 4.5, other precautions and section 5.3, environmental properties. 4.4 Special warnings 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 animals 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. To alter the course of an established clinical coccidial infection, in individual animals already showing signs of diarrhoea, additional supportive therapy may be required. 4.5 Special precautions for use i. Special precautions for use in animals ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash any splashes from skin or eyes immediately with water. iii. Other Precautions 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. For environmental reasons: 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. 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 these animals should only be applied to the same piece of land every third year. 4.6 Adverse reactions (frequency and seriousness) None known 4.7 Use during pregnancy, lactation or lay Laboratory studies in rat and rabbit have not produced any evidence of a teratogenic, foetotoxic or maternotoxic effect. 4.8 Interaction with other medicinal products and other forms of interaction None known