MoxiSolv 18.92 mg/g Oral Gel for Horses and Ponies

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 infestation based on its epidemiological features, for each
individual animal.
Repeated use for an extended period, particularly when using the same class of
substances, increases the risk of resistance development. Within a herd, maintenance
of susceptible refugia is essential to reduce that risk. Systematically applied interval-
based treatment and treatment of a whole herd 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 herd should be sought from the
responsible veterinarian.

Issued: January 2023
AN: 01477/2021
Partial cross-resistance between ivermectin and moxidectin has been reported. Cases
of resistance to moxidectin have been reported in equine cyathostomins,
equorum, Oxyuris equi in the EU and elsewhere. The use of this product should take
into account local information about susceptibility of the target parasites, where
available. It is recommended to further investigate cases of suspected resistance,
using an appropriate diagnostic method (e.g. the Faecal Egg Count Reduction Test
(FECRT)).
A shorter egg re-appearance periods after treatment with moxidectin is an early
indicator of the development of resistance in equine nematodes.
Confirmed resistance should be reported to the marketing authorisation holder or to
the competent authorities.

Special precautions for use in animals
To avoid overdosing, care should be taken to accurately dose foals, especially low body
weight foals or pony foals.
Do not use the same syringe to treat more than one animal unless horses are running
together or in direct contact with each

other in the same premises. The veterinary
medicinal product has been formulated specifically for use in horses only. Dogs or cats
may be adversely

affected by the concentration of moxidectin in this veterinary
medicinal product if they are allowed to ingest spilled paste or

have access to used
syringes. In dogs and cats, neurological clinical signs (such as ataxia, muscle tremor
and convulsions) and digestive clinical signs (such as hypersalivation) were recorded
on very rare occasions. These adverse effects are usually transient and disappear
spontaneously in most cases.
Special precautions to be taken by the person administering the product to the animals
Moxidectin and the excipients benzyl alcohol, polysorbate 80 and propylene glycol can
cause allergic reactions. People with known hypersensitivity to moxidectin or any of
the excipients should avoid all contact with the veterinary medicinal product.
This product can cause skin and eye irritation. Avoid direct contact with skin and eyes.
Wear protective gloves when handling the veterinary medicinal product. Wash hands
after use. In case of skin or eye contact, rinse immediately with a large amount of
water. If symptoms persist, seek medical advice and show the package leaflet or the
label to the physician.
Do not smoke, drink or eat while handling the 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. In order to reduce the emission of moxidectin to surface
water and based on the excretion profile of moxidectin when administered as the oral
formulation to horses, treated animals should not have access to watercourses during
the first week after treatment.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-
target organisms:

Issued: January 2023
AN: 01477/2021
• Faeces containing moxidectin excreted onto pasture by treated animals may
temporarily reduce the abundance of dung feeding organisms. Following treatment of
horses with the product, levels of moxidectin that are potentially toxic to dung beetles
and flies may be excreted over a period of more than 1 week and may decrease dung
fauna abundance.
• Moxidectin is inherently toxic to aquatic organisms including fish. The product
should be used only according to the label instructions.