Zermex 0.1% w/v Oral Solution for Sheep

Unnecessary use of antiparasitics or use deviating from the instructions given in
the SPC may increase the resistance selection pressure and lead to reduced
efficacy. The decision to use the product should be based on confirmation of the
parasitic species and burden, or of the risk of infection based on its
epidemiological features, for each flock.
Repeated use for an extended period, particularly when using the same class of
substances, increases the risk of resistance development. Within a flock,
maintenance of susceptible refugia is essential to reduce that risk. Systematically
applied interval-based treatment and treatment of a whole flock should be
avoided. Instead, if feasible, only selected individual animals or subgroups
should be treated (targeted selective treatment). This should be combined with
appropriate husbandry and pasture management measures. Guidance for each
specific flock should be sought from the responsible veterinarian.
Multiple resistance of Teladorsagia circumcincta
benzimidazole and ivermectin was reported throughout Europe. Moxidectin-
resistant Haemonchus contortus and were also
described. Therefore the use of this product should take into account local
information about susceptibility of the target parasites, where available.
Additionally, use should be based on 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.

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Clinical trials, after experimental and natural infestation, have shown that it is
effective against certain benzimidazole resistant strains of:
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It is recommended to further investigate cases of suspected resistance, using an
appropriate diagnostic method (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. Confirmed resistance should be
reported to the marketing authorisation holder or to the competent authorities.

i. Special precautions for use in animals
None known.
ii. Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Wear protective impermeable gloves during use.
Avoid direct contact with skin and eyes.
In case of contact with skin and eyes wash affected area with clean water.
Seek medical advice if irritation persists.
Do not smoke, drink or eat while handling the veterinary medicinal product.
Wash hands after use.
iii. 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 flock level.
Like other macrocyclic lactones, moxidectin has the potential to adversely
affect non-target organisms:
•
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

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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.
•
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.