Target species - Dogs
Indications for use, specifying the target species
To be used against infestations with fleas alone or in association with ticks.
Treatment and prevention of infestations by fleas (Ctenocephalides felis). One treatment prevents further infestations for 7 weeks.
Prevention of the multiplication of fleas by preventing flea eggs developing into adult fleas for 12 weeks after application.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon.
Treatment of infestations by ticks (Ixodes ricinus).
One treatment provides persistent acaricidal efficacy for 2 weeks against Ixodes ricinus, and for 4 weeks against Dermacentor reticulatus and Rhipicephalus sanguineus.
If ticks of some species (Dermacentor reticulatus, Rhipicephalus sanguineus) are present at the time of application, not all ticks may be killed within 48 hours.
Do not use in rabbits, as adverse reactions and even death could occur.
Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Shampooing or immersion of the animal in water directly after treatment may reduce the duration of activity. The product remains effective against fleas for 5 weeks when the dog is shampooed at monthly intervals after treatment. If the dog requires shampooing, it is better to do so before treatment.
Water immersion repeated on two occasions post treatment did not affect adulticidal efficacy against fleas nor the efficacy related to the prevention of the development of flea eggs into adult fleas.
The influence of water immersion or shampooing of the dog on the efficacy of the product against ticks has not been evaluated.
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 product does not prevent ticks from attaching to animals. Transmission of infectious disease by ticks cannot be completely excluded if conditions are unfavourable.
Immediate efficacy has been demonstrated against Ixodes ricinus, indicating that ticks of this species are likely to be killed within 48 hours of product application. If Dermacentor reticulatus or Rhipicephalus sanguineus ticks are present when the product is applied, these ticks may not be killed within the first 48 hours.
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 use
Special precautions for use in animals
For external use only.
Animals should be weighed accurately prior to treatment.
In absence of safety data, the product should not be used in puppies less than 10 weeks old and/or weighing less than 2 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.
Do not apply the product on wounds or damaged skin.
In the absence of additional safety studies, do not repeat the treatment at intervals of less than 4 weeks.
The use of the product has not been studied in sick and debilitated dogs.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may cause neurotoxicity.
The product may be harmful if swallowed.
Avoid contact with skin and mouth.
Avoid ingestion including hand-to-mouth contact.
Do not smoke, drink or eat during application.
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.
In the case of accidental skin contact, flush with water.
In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Fipronil and pyriproxyfen may adversely affect aquatic organisms. Dogs should be prevented from accessing streams and rivers for 48-hours following treatment.
The 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.
Adverse reactions (frequency and seriousness)
Transient cosmetic effects such as wet appearance or slight scaling may occur at the application site.
According to the accumulated experience on these active ingredients within spot on pharmaceutical forms, transient cutaneous reactions at the application site (squamosis, local alopecia, pruritus, erythema, skin discolouration) and general pruritus or alopecia may be observed after use. In very rare instances, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms) respiratory signs or vomiting might occur.
Use during pregnancy, lactation or lay
Laboratory studies using fipronil and pyriproxyfen have not shown any evidence of teratogenic or embryotoxic effect. Studies have not been carried out with this product in pregnant and lactating bitches. Use in pregnancy and lactation only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction