Fiproxile 402 mg/3600 mg Spot-on Solution for Very Large Dogs

The veterinary medicinal product remains effective after exposure to sunlight or if the
animal becomes wet after rain.
Avoid frequent swimming or shampooing of treated dogs as this may adversely affect
maintenance of the veterinary medicinal product effectiveness.
A dog with fleas may show an allergic reaction to the flea saliva called Flea Allergy
Dermatitis (FAD). If your dog has inflamed skin, is itchy and bites, scratches excessively
and is restless and uncomfortable, you should seek the advice of a veterinarian to
diagnose if your dog suffers from FAD.
To reduce re-infestation from emergence of new fleas, it is recommended to treat all dogs
in a household. Other animals living in the same household should also be treated with a
suitable product. Fleas from pets often infest the animal's basket, bedding and regular
resting areas such as carpets and soft furnishings which should be treated, in case of
massive infestation and at the beginning of the control measures, with a suitable
insecticide and vacuumed regularly.
There may be an attachment of single ticks or bites by single sand-flies or mosquitoes. For
this reason, the transmission of infectious diseases by these parasites cannot be excluded
if conditions are unfavourable.
Studies have shown anti-feeding effect of four weeks for sand-flies and mosquitoes.
Therefore, for short-term travel (less than 4 weeks) to endemic areas it is recommended to
apply the treatment immediately before expected exposure. For longer-term exposure (e.g.
animals living in endemic areas or travel duration longer than 4 weeks), the treatment
schedule should be based on local epidemiological information.

Special precautions for safe use in the target species:
Animals should be weighed accurately prior to treatment.
The safety of the veterinary medicinal product has not been established in dogs younger
than 12 weeks of age or in dogs weighing less than 1.5 kg.
Care should be taken to avoid the content of the pipette coming into contact with the eyes
or mouth of the recipient dogs. In particular oral uptake due to the licking of the application
site by treated or in-contact animals should be avoided.
This veterinary medicinal product is extremely poisonous to cats and could be fatal due to
the unique physiology of cats which is unable to metabolise certain compounds including
permethrin. In case of accidental dermal exposure, wash the cat with shampoo or soap,
and seek veterinary advice immediately. To prevent cats from being accidentally exposed
to the veterinary medicinal product, keep treated dogs away from cats after treatment until
the application site is dry. It is important to ensure that cats do not groom the site of
application on a dog, which has been treated with this veterinary medicinal product. In
case of exposure of this type, seek veterinary advice immediately if this occurs.
Do not use on rabbits and cats.
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. 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.
Therefore, avoid contact between the veterinary medicinal product and the mouth or eyes
including hand-to-mouth and hand-to-eye contacts. In case of accidental contact between
the veterinary medicinal product and eyes, immediately and thoroughly flush the eyes with
water. If eye irritation persists, seek medical advice and show the package leaflet or the
label to the physician.
Avoid contact with the skin. Should the veterinary medicinal product come into contact with
skin, wash the contacted area immediately with soap and water.
Wash hands thoroughly after use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
People with known hypersensitivity (allergy) to fipronil, permethrin or any of the excipients
should avoid contact with the veterinary medicinal product, which, on very rare occasions,
can cause respiratory irritation and dermal reactions in certain individuals.
Should symptoms occur, seek medical advice immediately and show the package leaflet
or the label to the physician.
Treated animals should not be handled or played with until the application site is dry and
for about 12 hours after treatment. It is therefore recommended to treat the animals in the
early evening or late afternoon in order to minimise contact with the treated animal. On the
day of treatment, treated animals should not be permitted to sleep with their owner,
especially children.
Keep the stored pipettes in the original packaging. In order to prevent children from getting
access to used pipettes, dispose of used pipettes immediately in a proper way.
Special precautions for the protection of the environment:
Fipronil and permethrin may adversely affect aquatic organisms. Dogs should not be
allowed to swim in water courses for 2 days after application.
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.