Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Fipronil
EU Pharmaceuticals Ltd
QP53AX15
Fipronil
Spot-on solution
AVM-GSL - Authorised Veterinary Medicine – General Sales List
Dogs
Ectoparasiticide
Authorized
2018-10-05
Unlimited renewal: May 2023 AN: 00094/2023 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eziflea Spot-on Solution Dog 402 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 4.02 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 402 mg EXCIPIENTS: Butylhydroxyanisole E320 0.804 mg Butylhydroxytoluene E321 0.402 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear, pale amber solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE Treatment of flea (_Ctenocephalides_ spp.) and tick (_Rhipicephalus sanguineus_ and _Ixodes Ricinus_) infestations. Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. The product has a persistent acaricidal efficacy for 4 weeks against ticks (_Rhipicephalus sanguineus_, _Ixodes ricinus_, _Dermacentor reticulatus_). If ticks of some species (_Dermacentorreticulatus_) are already present when the product is applied, all of the ticks may not be killed within the first 48 hours. Unlimited renewal: May 2023 AN: 00094/2023 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use on puppies less than 8 weeks old and /or weighing less than 40 kg. Do not use on sick (e.g. 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 on animals with known hypersensitivity to the active substance or to any of excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested. The product does not prevent ticks from attaching to the animals. If the animal has been treated prior to exposure to the ticks, the ticks will be killed in the first 24-48 hours after attachment. This will usually be prior to engorgement, minimising but not excluding the risk of transmis Read the complete document