Target Species
Horses and other equines.
Indications for use
For the treatment and control of adult and immature roundworms of the gastro-intestinal tract in horses and other equines.
This veterinary medicinal product is effective for the treatment and control of encysted mucosal 3rd and 4th stage small strongyle larvae and is also effective against encysted inhibited 3rd stage small strongyle larvae in the mucosa.
The veterinary medicinal product is effective in controlling other immature and mature roundworms including large redworm (Strongylus edentatus and Strongylus vulgaris) and migrating large redworm, Ascarids (Parascaris equorum), Oxyuris and Strongyloides species and benzimidazole susceptible adult and immature small strongyles (Cyathostomes).
The veterinary medicinal product has an ovicidal effect on nematode eggs.
None known.
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.
∙ Under dosing, which may be due to underestimation of body weight, misadministration of the veterinary medicinal 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 fenbendazole has been reported in cyathostomes in horses. Therefore, the use of this veterinary medicinal product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
Not applicable.
Operator warnings
Direct contact with the skin should be kept to a minimum. Personal protective equipment consisting of impermeable rubber gloves and long sleeves should be worn when handling the veterinary medicinal product. Remove and wash any contaminated clothing immediately.
In case of accidental spillage onto skin, wash the affected area thoroughly with soap and water.
Do not smoke, drink, or eat when handling the product.
Wash hands after use.
Adverse Reactions
Horses and other equines:
None known.
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.
Use during pregnancy or lactation
Pregnancy:
Pregnant mares and young foals may also be safely treated with fenbendazole at therapeutic dosage levels.
Interactions
None known.
Amounts to be administered and administration route
Oral use.
No dietary control is required before or after treatment.
The veterinary medicinal product is to be administered only for the treatment of individually fed animals or a small group of animals where the intake by individual animals can be effectively controlled.
For the treatment and control of migrating and tissue larval stages of large strongyles, encysted mucosal 3rd and 4th stage small strongyle larvae and encysted inhibited 3rd stage small strongyle larvae in the mucosa administer 5 ml per 65 kg bodyweight daily for 5 consecutive days (= 7.5 mg fenbendazole/kg bodyweight daily for 5 days).
The veterinary medicinal product can be easily administered by mixing with grain or concentrate feed. Mix the medicated feed thoroughly prior to administration, for example by rolling the drum or barrel.
The full daily dosage must be given as one administration.
To ensure a correct dosage, bodyweight should be determined as accurately as possible. The use of suitably calibrated equipment is recommended. Accuracy of the dosing device should be checked.
Shake bottle before use.
Recommended dosing programme
Inappropriate use of anthelmintics may increase resistance selection pressure and lead to reduced efficacy. The decision to use this veterinary medicinal product should be based on professional advice and take into account current best practice recommendations for parasite control.
Treatment with this product should form part of an integrated worming plan. Consult with your supplier for advice regarding wormers to use throughout the year.
Overdose
Benzimidazoles have a wide margin of safety.
Withdrawal periods
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.