Contraindications
Do not use in known cases of hypersensitivity to the active substance, other benzimidazoles or any of the excipients.
Special warnings for each target species
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.
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 body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
Special precautions for use
Special precautions for use in animals. The safety of the product at overdose has not been evaluated in chickens less than 8 weeks old. Do not use in cases of Capillaria spp infestations. The efficacy of the veterinary medicinal product at the recommended dosage is not sufficient for the treatment of infections with Capillaria spp. The absence of Capillaria spp infestation should be confirmed prior to use of the product. In case of Capillaria infestation, another appropriate anthelmintic veterinary medicinal product should be used. Use of the product deviating from the instructions in the SPC may increase the risk of development of resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals. This product may cause eye irritation. Avoid contact with the eyes and skin. When handling or mixing, care should be taken to avoid direct contact with the skin and eyes, and inhalation of dust, by wearing goggles, impervious gloves and a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143. Wash hands after use. In case of skin and/or eye contact, immediately rinse with plenty of water.
Other precautions. The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Adverse reactions (frequency and seriousness) None known.
Use during pregnancy, lactation or lay: Can be used in chickens in lay. The safety of the product has not been evaluated in breeding pheasants. Therefore, in these birds, use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction: None known.
Overdose (symptoms, emergency procedures, antidotes):
No undesirable effects have been observed in chickens (8-9 weeks of age) at up to 5 times the recommended dose.
Although not observed in studies investigating the effects of overdosing in other classes of the target species, an increase in water intake compared with controls has been reported in laying hens treated with a dose exceeding 3X the recommended dose.
A small (<3%) but statistically significant difference in mean body weight of chicks from treated layers was observed in conditions of overdosing (3X the recommended dose for a duration exceeding 3X the recommended one in clinical conditions).