Fipralone Duo 50 mg/60 mg Spot-on Solution for Cats

Wetting of the haircoat with water 2 hours before product application and twice during the
claimed period of efficacy against fleas (at two week intervals against adult fleas or four
week intervals against developing flea stages) was investigated during two laboratory
studies. Wetting of the haircoat with water as described did not adversely affect veterinary
medicinal product effectiveness.
The impact of shampooing on veterinary medicinal product effectiveness has not been
investigated. If a cat requires shampooing it is recommended that this is done before
applying the veterinary medicinal product.
At the beginning of the control measures, in the case of an infestation, the animal's basket,
bedding and regular resting areas such as carpets and soft furnishings should be treated,
with a suitable insecticide and vacuumed regularly.
To reduce environmental flea challenge, all animals living in the same household should
also be treated with a suitable flea control product.
The veterinary medicinal product does not prevent ticks from attaching to animals. If the
animal has been treated prior to exposure to the ticks, the ticks will be killed within 48
hours after attachment. This will usually be prior to engorgement, minimising but not
excluding the risk of transmission of diseases.
Once dead, ticks will often drop off the animal. Any remaining ticks should be carefully
removed, ensuring that their mouth parts are not left within the skin.

Special precautions for safe use in the target species:
For external use only. Do not administer orally.
Animals should be weighed accurately prior to treatment.
The safety of the veterinary medicinal product has not been established in cats younger
than 10 weeks of age or in cats weighing less than 1.0 kg.
Avoid contact with the animal’s eyes. In the case of accidental eye contact, flush the eyes
with water.
Care should be taken to apply the veterinary medicinal product correctly as described
under section 3.9. Do not apply the veterinary medicinal product on wounds or damaged
skin. It is important to make sure that the veterinary medicinal product is applied directly
onto an area of dry skin where the animal cannot lick it off and to make sure that animals
do not lick each other following treatment.
The use of the veterinary medicinal product has not been studied in sick or debilitated
cats. Use in sick or debilitated animals only in accordance with a benefit-risk assessment
performed by the responsible veterinarian.
In the absence of additional safety studies, do not repeat the treatment at intervals of less
than 4 weeks.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product may cause neurotoxicity. The veterinary medicinal
product may be harmful if swallowed.
Avoid ingestion including hand to mouth contact.
Do not smoke, drink or eat during application.
In case of accidental ingestion, seek medical advice immediately and show the package
leaflet or the label to the physician.
This veterinary medicinal product can cause eye and mucous membrane irritation.
Avoid contact with skin, eye and mouth, including hand to eye contact.
In the case of accidental skin or eye contact, immediately and thoroughly flush with water.
If skin or eye irritation persists, seek medical advice immediately and show the package
leaflet or the label to the physician.
Wash hands after use.
Treated animals should not be handled until the application site is dry, and children should
not be allowed to play with treated animals until the application site is dry. It is therefore
recommended that animals are not treated during the day, but should be treated during the
early evening, and that recently treated animals should not be allowed to sleep with
owners, especially children.
Keep the pipettes in the original packaging until ready for use and dispose of used pipettes
immediately.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
The veterinary medicinal product may have adverse effects on painted, varnished or other
household surfaces or furnishings. Allow the application site to dry before permitting
contact with such materials.