Indications for use, specifying the target species
For the treatment and control of liver fluke infections in sheep caused by all stages of triclabendazole susceptible Fasciola hepatica from 2 day old immature to adult fluke.

Contraindications
None

Special warnings for each target species
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 body weight, 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 species in small ruminants in a number of countries including the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of trematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Special precautions for use
i. Special precautions for use in animals
Assess bodyweight as accurately as possible before calculating dose. Shake the container thoroughly before use. Clean drenching equipment before and after use. Use unaltered product from the original container.

Parasite resistance to a particular class of anthelmintic may develop following frequent repeated use or misuse of an anthelmintic of that class. To reduce this risk, dosing programmes should be discussed with your Veterinary Adviser. Efficacy of this product against liver fluke is reduced if triclabendazole-resistant strains are present. If lack of efficacy is suspected seek veterinary advice.

ii. Special precautions to be taken by the person administering the veterinary medicinal 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 work.

Adverse reactions (frequency and seriousness)
None.

Use during pregnancy, lactation or lay
The product can be used in pregnant ewes not producing milk for human consumption. Not authorised for use in ewes producing milk for human consumption including during the dry period.

Interaction with other medicinal products and other forms of interaction
None known.

Amounts to be administered and administration route
For oral administration. Dose: 10mg triclabendazole /kg bodyweight. (1ml Fasinex 5% per 5kg bodyweight).

Do not mix with other products. To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Most types of automatic drenching guns may be used.

Do not mix with other products before administration except if premixing is done by a veterinary surgeon or a pharmacist.

Treatment of acute outbreaks: The flock should be treated immediately after diagnosis is reached. Veterinary advice should be sought for subsequent dosing intervals.

Overdose (symptoms, emergency procedures, antidotes), if necessary
No treatment specified.

Withdrawal period(s)
Animals must not be slaughtered for human consumption during treatment. Sheep may be slaughtered for human consumption only after 56 days from the last treatment.

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.