Target species
Cattle.
Indications for use, specifying the target species
For the treatment of acute, subacute and chronic infection due to early immature, immature, and mature stages of Fasciola hepatica. If infected animals are treated before disease has developed, fasciolosis can be prevented.
Contraindications
None known.
Special warnings
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.
•Underdosing, which may be due to underestimation of bodyweight, misadministration of the veterinary medicinal 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, and 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 a number of countries including ones in the EU. Therefore the use of this veterinary medicinal product should be based on local epidemiological information about susceptibility of F. hepatica and recommendations on how to limit further selection for resistance to anthelmintics. Dosing programmes should be discussed with your Veterinary Adviser.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink, or smoke while handling the veterinary medicinal product. Wash hands and exposed skin after handling the veterinary medicinal product.
In case of accidental spillage onto skin or in eyes, wash immediately with water. Take off any contaminated clothes.
Special precautions for the protection of the environment:
The veterinary medicinal product may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the veterinary medicinal product or empty containers.
Other precautions
None known.
Adverse reactions (frequency and seriousness)
Target species: cattle
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Laboratory studies have not produced any evidence of teratogenic or foetotoxic effects.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be 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 over-dosing.
Administer 5 mL/100 kg body weight, equivalent to 12 mg triclabendazole per kg of body weight. The veterinary medicinal product is administered orally after thorough shaking of the suspension. Most types of automatic drenching guns are suitable. Clean drenching gun before and after use.
The veterinary medicinal product can safely be given to young, pregnant or stressed cattle, cattle not producing milk intended for human consumption or dry cattle.
The veterinary medicinal product is given once. The administration may be repeated several weeks or months after the first treatment depending on the epidemiological situation. In case of acute fasciolosis, treat immediately, then repeat in approximately 4-6 weeks, and consult a veterinarian for advice.
Body Weight (kg) | Volume to Administer (ml) |
Up to 50 kg | 2.5 |
>50-70 | 3.5 |
>70-100 | 5 |
>100-150 | 7.5 |
>150-200 | 10 |
>200-300 | 15 |
>300-400 | 20 |
>400-500 | 25 |
Overdose (symptoms, emergency procedures, antidotes), if necessary
A single oral dose of 150-200 mg triclabendazole/kg of body weight was shown to lead to side effects such as stumbling gait, depression, and decreased appetite. These side effects are slight and last 1 to 3 days. An antidote is not known.
Withdrawal period
Meat and offal: 52 days.
Milk: Milk for human consumption may only be taken from 48 hours after calving. Not intended for use within 48 days of calving. Should a cow calve earlier than 48 days after the last treatment, milk for human consumption may only be taken from 50 days after the last treatment.