Flukanide 30 mg/ml Oral Suspension 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
individual 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.
Resistance to rafoxanide has been reported in immature 6-week-old Fasciola
hepatica in artificially infected sheep in Australia (1989). In the study, two isolates of
Fasciola hepatica that were resistant to rafoxanide were also resistant to closantel
(another salicylanilide), indicating possible side resistance. However, the fluke
isolates resistant to rafoxanide and closantel did not demonstrate side resistance to
the salicylanilide oxyclozanide.
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 tests strongly suggest resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different mode of action
should be used.

Special precautions for safe use in the target species:
When a dosing gun is used to administer the product, care must be taken to avoid
damage to the pharyngeal region.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This product may be irritating to skin and eyes or cause hypersensitivity. People with
known hypersensitivity to rafoxanide or any of the listed excipients should avoid
contact with the product. Wear nitrile rubber gloves when applying the product. Do
not eat, drink, or smoke while handling the product. If accidental contact with the skin
or eyes occurs, wash off any skin contamination with soap and water immediately.
Rinse the affected eyes thoroughly with clean, fresh water. Remove and wash any
contaminated clothing immediately. Wash hands after use.
Special precautions for the protection of the environment:
Rafoxanide is very toxic to dung insects. Long term effects on dung insects caused
by continuous or repeated use cannot be excluded. Therefore, the product must only
be administered once per year to affected animals only.