Target species
Cattle & Sheep.
Indications for use
For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to triclabendazole.
Contra-indications
Do not use in animals known to be hypersensitive to the active substance.
Special precautions for use in animals
Care should be taken to avoid the following practices, because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. Under dosing, which may be due to underestimation of bodyweight, misadministration of the product or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics 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 anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Resistance to triclabendazole has been reported in Fasciola hepatica in cattle and sheep.Therefore, the use of this product should be based on local (regional/farm) epidemiological information about susceptibility of the Fasciola hepatica and recommendations on how to limit further selection for resistance to anthelmintics.
Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx.
Special Precautions to be taken by the person administering the product to animals
When using, do not eat, drink or smoke.
Wash splashes from eyes and skin immediately.
Take off immediately any contaminated clothing.
Wash hands and exposed skin before meals and after use.
Special precautions for the protection of the environment
The use of this veterinary medicinal product may have harmful effects on fish and aquatic invertebrates. Cattle and sheep must not have any access to the surface water such as streams, ponds or ditches within 7 days after treatment. When spreading manure from treated animals on arable lands, a safety distance of 10 metres to adjacent surface waters must be kept.
Adverse reactions
Undetermined frequency (cannot be estimated from the available data) | Skin inflammation1 |
1.Occasionally, of the unpigmented skin, including the udder and the teats may occur after treatment in cattle exposed to intense sunshine. 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.
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation. However, the veterinary medicinal product is not permitted for use during lactation in animals producing milk for human consumption.
Interactions
None known.
Amounts to be administered and administration route
Oral use. For single oral administration only. The use of suitably calibrated dosing equipment is recommended. The veterinary medicinal product is suitable for most types of automatic drenching guns. Shake the container before use. Use unaltered from original container. Clean drenching equipment before and after use.
Dosage:
Cattle: The recommended dose rate is 12 mg triclabendazole per kg bodyweight.
Sheep: The recommended dose rate is 10 mg triclabendazole per kg bodyweight.
Cattle Dosage Guide: Endofluke 100 mg/ml Oral Suspension |
Practical Dosage Guide: Cattle: 6ml per 50 kg bodyweight |
Animal Weight | Dose of Product |
50kg | 6ml |
100kg | 12ml |
150kg | 18ml |
200kg | 24ml |
250kg | 30ml |
300kg | 36ml |
350kg | 42ml |
400kg | 48ml |
Free each additional 50kg | 6ml |
Sheep: 1 ml per 10kg bodyweight
Sheep Dosage Guide: Endofluke 100 mg/ml Oral Suspension |
Practical Dosage Guide: Sheep: 1ml per 10kg bodyweight |
Animal Weight | Dose of product |
10kg | 1ml |
20kg | 2ml |
30kg | 3ml |
40kg | 4ml |
50kg | 5ml |
60kg | 6ml |
For each additional 10kg | 1ml |
Underdosing could result in ineffective use and may favour resistance development.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Accuracy of the dosing device should be thoroughly checked.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.
For infestations with Fasciola hepatica, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifecycle.
To avoid the potential for the accumulation of residues following repeat administration of the veterinary medicinal product; animals should not be treated with a frequency of less than 10 weeks.
Overdose
A single oral dose of 150-200 mg triclabendazole/kg of live bodyweight may lead to side effects such as unsteady gait, dullness and reduced appetite. These side effects are slight and last 1 to 5 days. An antidote is not known.
Withdrawal periods
Cattle and sheep meat and offal: 56 days
Cattle: Milk for human consumption: Milk may only be taken from 48 hours after calving. Not intended for use within 45 days of calving. If calving occurs before 45 days after treatment, milk for human consumption may only be taken after day 45 plus 48 hours after the treatment.
Sheep Milk: Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.