Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
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
- 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.
Resistance to macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries. In 2018, throughout Europe, multiple resistance of Teladorsagia circumcincta to moxidectin, levamisole, benzimidazole and ivermectin were reported. Moxidectin resistant Haemonchus contortus and Trichostrongylus colubriformis were also described. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to antiparasitic compounds.
Special precautions for use in animals
None known.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
- Avoid direct contact with skin and eyes.
- Wear impermeable rubber gloves during use.
- In the event of eye contact, flush the eye with copious amounts of clean water
and seek medical advice.
- Wash hands or any exposed area after use.
- Do not smoke, eat or drink when handling this product.
Other precautions regarding impact on 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 4 days 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 oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days after treatment.
Adverse reactions (frequency and seriousness)
None Known.
Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant, lactating and breeding animals.
Can be used during pregnancy and lactation. Can be used in breeding animals.
Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms have not been observed at less than 5 times the recommended dose.
They are manifested as transient salivation, depression, drowsiness and ataxia 8 to 12 hours post-treatment. Treatment is not generally necessary and recovery is generally complete within 24 to 48 hours. There is no specific antidote.
Withdrawal period
Meat and offal: 14 days.
Milk: 120 hours (5 days).