Moxidectin EU Pharmaceuticals 5 mg/ml Pour-on Solution for Cattle

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.

Revised: October 2025
AN: 02008/2025

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 clothing 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:

Revised: October 2025
AN: 02008/2025
• 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.