Dogs.

The treatment and prevention of flea (Ctenocephalides felis) infestations in dogs. The duration of protection against flea infestations is 5 weeks. The product protects against new tick (Dermacentor reticulatus, Rhipicephalus sanguineus) infestations in dogs from day 7 to day 28 after application of the product.

Do not use on dogs less than 8 weeks old and/or weighing less than 2kg. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use on sick (e.g. systemic disease, fever) or convalescent animals. Do not use in rabbits, as adverse reactions and even death could occur. Do not use in cats, as this could lead to overdosing.

For optimal control of flea infestation in multi-pet household, all dogs and cats in the household 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 cases of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly. No data on the effect of bathing/shampooing on the efficacy in dogs are available. Shampooing prior to or frequently after treatment may reduce product efficacy. The product does not prevent ticks from attaching to the animal. In addition, efficacy against existing tick infestations has not been demonstrated. For this reason, transmission of infectious diseases cannot be excluded. It is known that the product will protect against new tick infestations from day 7 to day 28 after application of the product. However, it is not known whether efficacy against new tick infestations persists beyond 4 weeks. Therefore, there may be gaps in protection from such infestations after subsequent reapplication of the product, even if the product is reapplied at the minimum interval of 4 weeks.

Keep pipettes in original packaging until ready for use. Persons with known hypersensitivity to fipronil or to any of the excipients should avoid contact with the product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. This product can cause mucous membrane and eye irritation. Therefore, contact of the product with mouth and eyes should be avoided. After accidental ocular exposure the eye should be rinsed carefully with plain water. Ingestion of the product is harmful. Prevent children getting access to the pipettes and discard the used pipettes immediately after applying the product. 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. Do not smoke, drink or eat during application. Wash hands after use.

Dogs should not be allowed to swim in watercourses for 2 days after application. The product may have adverse effects on painted, varnished or other household surfaces or furnishings.

If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier. Among the very rare suspected adverse reactions, transient cutaneous reactions at the application site (skin discolouration, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use. Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs), vomiting or respiratory signs have been observed after use. Do not overdose. The risk of adverse effects may increase in cases of overdose.

Laboratory studies using fipronil have not produced any evidence of teratogenic or fetotoxic effects. In the absence of studies to evaluate the safety of this product in pregnant or lactating animals, use only according to the benefit/risk assessment by the responsible veterinary surgeon.

Do not use simultaneously with other flea products which are applied directly onto the animal.

Hold upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Cut off the top of the pipette with scissors. Part the coat between the shoulder blades and at the base of the head until the skin is visible. Place the tip of the pipette on the skin and gently apply half of its contents onto the skin at both application sites. Avoid applying the solution on the fur and do not rub into the skin. Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will usually disappear within 24–48 hours post-application. In the absence of safety studies, the minimum treatment interval is four weeks.

No adverse effects have been demonstrated in the tolerance studies carried out with puppies at 8 weeks, growing dogs and dogs weighing 2kg treated once at five times the recommended dose. The risk of causing side effects may however increase with overdosing. It is therefore recommended to always treat animals with the appropriate pipette size.