Target species
Dogs.
Indications for use, specifying the target species
For the treatment of infestations by fleas (Ctenocephalides felis). The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks.
The product has a persistent acaricidal efficacy against Ixodes ricinus for up to 2 weeks, Rhipicephalus sanguineus for up to 3 weeks and Dermacentor reticulatus for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week.
The product can be used as part of a treatment programme for Flea Allergy Dermatitis where this has been previously diagnosed by a Veterinary Surgeon.
Contraindications
Do not use in dogs weighing less than 20 kg.
In the absence of available data, the product should not be used in puppies less than 8 weeks old.
Do not use in sick (systemic diseases, fever…) or convalescent animals.
Do not use in rabbits, as adverse reactions and even death could occur.
This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing.
Do not use in cases of known hypersensitivity to fipronil or to any of the excipients.
Special warnings for each target species
The product does not prevent ticks from attaching to the animals, but ticks may be killed in the first 24-48 hours after attachment prior to full engorgement and therefore minimising but not excluding the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may easily be removed by a gentle pull.
When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other dogs in the household are recommended.
For optimal control of flea infestation in multi-pet household, all dogs and cats in the house should be treated with a suitable insecticide.
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.
Avoid frequent swimming or shampooing of the animal because the maintenance of effectiveness of the product in these cases has not been tested.
Special precautions for use
(i) Special precautions for use in animals
Avoid contact with the animal’s eyes. In the case of accidental eye contact immediately and thoroughly flush the eyes with water.
It is important to make sure that the product is applied to an area where the animal cannot lick it off, and to make sure that animals do not lick each other following treatment.
Do not apply the product on wounds or damaged skin.
(ii) Special precautions to be taken by the person administering the veterinary medicinal product to the animals
This product can cause mucous membrane and eye irritation. Therefore, contact of the product with the mouth and eyes should be avoided.
In cases of accidental eye contact, immediately and thoroughly rinse the eye with plain water. If eye irritation persists seek medical advice and show the package leaflet or the label to a physician.
People with a known hypersensitivity to fipronil or excipients (section, Pharmaceutical Particulars) should avoid contact with the veterinary product.
Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water.
Wash hands after use. Do not smoke, drink or eat during application.
Treated animals should not be handled until this 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 pipettes in original packaging and dispose of used pipettes immediately.
This product is flammable. Keep away from heat, sparks, open flame or other sources of ignition.
(iii) Other precautions
Fipronil may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application.
The alcohol carrier may have adverse effect on painted, varnished or other household surfaces or furnishings.
Adverse reactions (frequency and seriousness)
If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier.
The following adverse reactions are reported very rarely:
•Transient cutaneous reactions at the application site (skin discoloration, local alopecia, pruritus, erythema)
•General pruritus
•Alopecia,
•Hypersalivation,
•Reversible neurological signs (hyperaesthesia, depression, nervous signs),
•Vomiting,
•Respiratory signs
The frequency of adverse reactions is defined using the following convention:
•Very rare ( less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
Laboratory studies using fipronil have not shown any evidence of teratogenic or embryotoxic effects. Studies have not been carried out with this product in pregnant and lactating animals. Use in pregnancy and lactation only in accordance with professional veterinary advice and a benefit/risk assessment.
Interaction with other medicinal products and other forms of interaction
None known.
