Target Species
Sheep (lambs)
Cattle (calves)
Indications for use for each target species
Lambs: Prevention of coccidiosis caused by Eimeria crandallis and Eimeria ovinoidalis.
Calves: Prevention of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Contraindications
Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.
Special Warnings
If there is no recent and confirmed history of clinical coccidiosis, the presence of the disease in the flock or herd must be established before the product is used.
The preferred timing of treatment is directed by the known epidemiology of Eimeria spp. with treatment being most effective during the pre-patent phase of infection before clinical signs occur.
Calves: In certain cases, only a transient reduction of oocyst shedding may be achieved.
Suspected clinical cases of resistance to anticoccidials should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular antiprotozoal, an anticoccidial belonging to another pharmacological class and having a different mode of action should be used.
Cross-resistance between toltrazuril and diclazuril is possible and should be investigated. Use of diclazuril should be carefully considered when susceptibility testing has shown resistance to triazine-derivates because its effectiveness may be reduced.
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Coccidiosis is an indicator of insufficient hygiene in the flock/pen. It is recommended to improve hygiene and to treat all lambs in a group and all calves in a pen. This will contribute to reduce the infection pressure and assure a better epidemiological control of the coccidiosis infection.
To alter the course of an established clinical coccidial infection, in individual animals already showing signs of diarrhoea, additional supportive fluid therapy is essential.
Preventative use of this veterinary product should be restricted to animals that have very high risk of infection.
Frequent and repeated use of antiprotozoals may lead to the development of resistance in the target parasite.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash hands after administration of the product
Special precautions for the protection of the environment:
Not applicable.
Adverse Events
Sheep (lambs) and Cattle (calves):
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorder (e.g. Diarrhoea1,2); Lethargy, Recumbency; Agitation; Neurological signs (e.g. Paresis) |
1 with possible presence of blood
2 in some treated animals, even though oocyst excretion is reduced to a very low level.
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 the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
None known.
Administration Routes & Dosage
Oral use.
Shake well before use.
The use of suitably calibrated measuring equipment is recommended to ensure accurate dosing. This is particularly important when administering small volumes. To ensure a correct dosage, body weight should be determined as accurately as possible.
If animals are to be treated collectively rather than individually, they should be grouped according to their body weight and dosed accordingly, in order to avoid under- or overdosing.
1 mg diclazuril per kg body weight (i.e. 1 ml of the veterinary medicinal product per 2.5 kg body weight), in a single oral administration.
Body weight (Lambs and Calves) | Dose Volume 1 mg/kg |
5kg | 2ml |
7.5kg | 3ml |
10kg | 4ml |
12.5kg | 5ml |
15kg | 6ml |
20kg | 8ml |
25kg | 10ml |
50kg | 20ml |
75kg | 30ml |
100kg | 40ml |
150kg | 60ml |
175kg | 70ml |
200kg | 80ml |
The oral suspension should be administered directly in the mouth with appropriate drenching equipment.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Sheep (lambs): No clinical signs of overdose were noted after administration of 5 times the recommended dose. Cattle (calves): No clinical signs of overdose were noted after a single administration of 5 times the recommended dose. In case of repeated administration of 3 to 5 times the dose, on 3 consecutive days, a softening and a colour change (dark brown) of the faeces can be observed in some calves. These observations were transient and disappeared without specific treatment.
Withdrawal Periods
Meat and offal: Sheep (lambs): zero days
Cattle (calves): zero days
Not authorised for use in animals producing milk for human consumption