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 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 liver fluke (Fasciola hepatica) in cattle and sheep in a number of countries, including ones in the EU. Therefore, the use of this product should be based on a local epidemiological information about susceptibility of F. hepatica and recommendations on how to limit further selection for resistance to anthelmintics. To reduce the risk of parasite resistance, dosing programmes should be discussed with a veterinary surgeon. FASINEX 100 contains the anthelmintic triclabendazole and losses associated with resistant strains of fluke in sheep treated with triclabendazole can be significant. If signs of fasciolosis continue after treatment with FASINEX 100, DO NOT REPEAT THE DOSE and do not dose with other products containing triclabendazole. Seek veterinary advice. If resistance is suspected or confirmed, you should change active ingredient on veterinary advice.

Assess bodyweight as accurately as possible before calculating dose. Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with your veterinary adviser.

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.

Accuracy of the dosing device should be checked.

In sheep, a single oral dose of 150-200 mg triclabendazole/kg body weight (15-20 times the recommended dose) may lead to side effects, such as unsteady gait, dullness and reduced appetite. These side affects are slight and transient. An antidote is not known.

FASINEX 100 is neither embryotoxic nor teratogenic, and can be used in all stages of pregnancy and lactation. In cattle, do not use in lactating animals producing milk for human consumption. In sheep, because of milk residues, treatment of ewes producing milk for human consumption is recommended during the dry period.

Overdose in cattle - No treatment specified.

Do not eat, drink, or smoke while handling the product. Wash hands and exposed skin before meals and after work. In case of accidental spillage onto skin or in eyes, wash immediately with water. Take off any contaminated clothing immediately.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulatory authority. FASINEX 100 should not enter water courses as this may be dangerous for fish and other aquatic organisms.

Meat and Offal - Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 56 days from last treatment. Sheep may be slaughtered for human consumption only after 35 days from last treatment.

Milk - Do not administer to animal producing milk for human consumption.