Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
In chickens, optimal results can only be achieved if strict rules of hygiene are respected in the maintenance of the cages.
In both 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.
Special precautions for use in animals
No undesirable effects have been demonstrated
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Direct contact with veterinary medicinal product should be avoided. Wear protective gloves while using the product. Wash hands after use.
People with known hypersensitivity to flubendazole should avoid contact with the veterinary medicinal product. In the event of eye contact, rinse thoroughly with water. In case of appearance and persistence of conjunctival redness, seek medical advice and show the package leaflet to the physician.
Adverse reactions
Pigs: None known.
Chickens: Undetermined frequency (cannot be estimated from the available data): Development disorders of the feathers cannot be fully excluded after the administration of flubendazole.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Overdose
Flubendazole has a low acute oral toxicity.
In hens, no undesirable effects have been observed after administration of up to 15 mg/kg b.w./day flubendazole.
In porcine (pigs), no adverse effects have been observed after administration of up to 50 mg/kg b.w./day flubendazole.
In situation when accidental overdose is suspected of having occurred, there is no antidote and treatment should be symptomatic.
Interactions with other medicinal products and other forms of interaction
None known. In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Withdrawal Periods
Chicken (Meat & Offal): 2 days
Pigs (Meat & Offal):
- Dose 1 mg/kg body weight for 5 days: 3 days
- Dose 2.5 mg/kg body weight for 2 days: 4 days
Eggs: zero days