Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Not to be used in other species as severe adverse reactions, including fatalities in dogs, may occur.
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.
- 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. Selection of resistant genes leading to the development of resistance can ultimately result in ineffective anthelmintic therapy.
Partial cross-resistance between ivermectin and moxidectin has been reported in nematode parasites. Cases of resistance to moxidectin have been reported in gastrointestinal nematode parasites of cattle. Therefore, 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 limit further selection for resistance to anthelmintics.
Special precautions for use in animals
For topical application only.
Avermectins may not be well tolerated in all non-target species. Cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises.
Care should be taken to avoid ingestion of spilled product or access to containers by these other species.
To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of fly activity and before the larvae reach their resting sites: consult the veterinarian to know the correct treatment period. Disease associated with warble fly is notifiable in some regions.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product can cause skin and eye irritation. Avoid direct contact with skin and eyes. Do not smoke, eat or drink when handling this product.
Wear impermeable rubber gloves and protective clothes during use.
Wash hands or any exposed area after use.
In the event of eye contact, flush the eye with copious amounts of clean water and seek medical advice
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 cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 2 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, field studies 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 pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.
Adverse reactions (frequency and seriousness)
Reactions at the site of application may occur after application in very rare occasions.
Neurological signs (including ataxia, trembling and lethargy) have been reported in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant and lactating animals and breeding bulls.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms of overdose have been observed with the product given at ten times the recommended dose. They are manifested as transient salivation, depression, drowsiness and ataxia. There is no specific antidote.