Do not use in sheep less than 15 kg bodyweight.
Do not inject the product by the intravascular route. Intravascular injection may result in ataxia, paralysis, convulsions, collapse and death. See “Dosage and administration” section above.
Do not use in cases of hypersensitivity to the active substance or to any excipients.
Sheep:
Very common (>1 animal / 10 animals treated): | Injection site swelling1 Injection site inflammation |
Rare (1 to 10 animals / 10,000 animals treated): | Increased salivation2 Ataxia2, Drowsiness2 Depression2 |
1generally resolves without treatment within 7 days.
2transitory, no specific antidote, no particular treatment is required; these symptoms usually disappear within 24 to 48 hours.
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 the national competent authority via the national reporting system. See also the package leaflet for the respective contact details.
Signs of overdoses have not been seen at 3 and 5 times the recommended dose. However, if they do occur they should be consistent with the mode of action of moxidectin and would be manifested as transient salivation, depression, drowsiness and ataxia 24 to 36 hours post-treatment. The signs would usually disappear within 36 to 72 hours without treatment. There is no specific antidote.
The product has been formulated specifically for subcutaneous injection in the base of the ear of sheep and must not be given by any other route of administration or to any other 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 bodyweight, 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 macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries. In 2008, throughout Europe, moxidectin resistance is very rare; it has been reported in a single case involving a levamisole-, benzimidazole and ivermectin-resistant strain of Teladorsagia circumcincta. Therefore the use of moxidectin should be based on local (regional, farm) epidemiological information about susceptibility of nematodes, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to anthelmintics. These precautions are especially important when moxidectin is being used to control resistant strains.
Trials have shown that moxidectin is effective against certain strains of Haemonchus contortus, Teladorsagia circumcinta and Trichostrongylus spp. resistant to benzimidazoles.
Withdrawal period
Meat and offal: 104 days.
Milk: Not permitted for use in dairy sheep, at any stage of life.
The withdrawal period is based solely on a single injection at the base of the ear.
Operator warnings
Avoid direct contact with skin and eyes. Wash hands after use. Do not smoke, drink or eat while handling the product. Take care to avoid self-injection. If this occurs, it is unlikely that any product related symptoms will be observed. Advice to Medical Practitioners in case of accidental self-injection: treat symptomatically.
Special precautions for the protection of the environment
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible. Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:
•Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period. It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, studies with incurred residues indicate no long-term effects. Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.
•Moxidectin is inherently toxic to aquatic organisms including fish. The product should be used only according to the label instructions. Based on the excretion profile of moxidectin when administered as the injectable formulation to sheep, treated animals should not have access to watercourses during the first 11 days after treatment.