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Contra-indications, warnings, etc
Do not use in cases of known hypersensitivity to the active ingredient.
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.
• Under dosing, which may be due to under estimation 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 hepatica in 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.
Special precautions for use in animals
Only use for liverfluke strains susceptible to triclabendazole. Care must be taken not to damage the mouth or pharyngeal region when dosing. Clean drenching equipment before and after use. Shake container before use. Use unaltered product from the original container.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
When using the product do not eat, drink or smoke. Wear gloves. Wash splashes from eyes and skin immediately. Take off any contaminated clothing immediately. Wash hands and exposed skin before meals and after work. In cases of hypersensitivity and contact allergy, direct skin contact and inhalation should be avoided.
Other precautions
The use of Tribex 5% may have harmful effects on fish and aquatic invertebrates. Sheep must not have any access to surface water such as streams, ponds or ditches within 7 days after treatment with Tribex. When spreading manure from treated animals on arable lands a safety distance of 10 m to adjacent surface waters must be kept.
Adverse reactions (frequency and seriousness)
None known
Use during pregnancy, lactation or lay
The product can be safely given to pregnant sheep .
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes)
No adverse effects were reported following a dose of 12.5 times the recommended dose. At higher doses (up to 20-fold), mild transient ataxia and weight loss were observed in some animals 3-6 days after treatment.
Withdrawal Period(s)
Meat and offal: 56 days.
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.