Nexpraz Duo 18.7 mg/g + 140.3 mg/g Oral Paste for Horses

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
group of animals.
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.
In the absence of risk of co-infection, a narrow spectrum product should be used.
Partial cross-resistance between ivermectin and moxidectin has been reported.
Furthermore, resistance to ivermectin (an avermectin) has been reported in
equorum in horses in a number of countries including the EU. Therefore, 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. Faecal Egg Count Reduction Test). Confirmed
resistance should be reported to the marketing authorisation holder or to the competent
authorities.”
Tapeworm infestations are rare in foals before 2 months of age, therefore treatment of
foals younger than 2 months of age is not considered necessary.
Confirmed cases of praziquantel resistance in tapeworms infecting horses have been
reported in the USA, and the first isolated cases of ivermectin resistance in
cythostomins have been reported in the USA from horses imported from the EU. Given
the global horse trade, the risk of resistance emerging in Europe is significant.
It is recommended to further investigate suspected resistance cases using an
appropriate diagnostic method (e.g., Faecal Egg Count Reduction Test), especially in
imported animals or those without a known history of origin.
Tapeworm speciation was not performed in the efficacy study of the veterinary
medicinal product. The indication for is based on the typical
pathoanatomical finding observed during the efficacy study and its predominant
prevalence among equine tapeworms.

Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to ivermectin, praziquantel, tartrazine, or cinnamon
should avoid contact with the veterinary medicinal product.
This veterinary medicinal product may cause skin and eye irritation. Avoid contact with
skin and eyes. Personal protective equipment consisting of gloves should be worn
when handling the veterinary medicinal product.
In the case of accidental contact with skin or eyes wash the affected area immediately
with plenty of water. If skin or eye irritation persist, seek medical advice.
In the case of accidental ingestion, especially by a child, seek medical advice
immediately and show the package leaflet or label to the physician.
Do not eat, drink or smoke while handling the veterinary medicinal product.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Avermectins may not be well tolerated in all non-target species. Cases of intolerance
have been reported in dogs, especially collies, Old English Shepherd dogs and related
breeds or their crossbreds, as well as in turtles and tortoises.
Dogs and cats should not have access to paste residues or used applicators due to
the possibility of side effects associated with ivermectin toxicity.