Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)
Fipronil
Vetoquinol UK Ltd
QP53AX15
Fipronil
Spot-on solution
NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person
Dogs
Ectoparasiticide
Authorized
2011-10-03
Revised: September 2018 AN: 00540/2018 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Flevox 134 mg spot-on solution for medium dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pipette of 1.34 ml contains: ACTIVE SUBSTANCE: Fipronil 134 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.536 mg Butylhydroxytoluene (E321) 0.268 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution Limpid, yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: Treatment of flea (Ctenocephalides spp.) and biting/chewing lice (_Trichodectes canis)_ infestations in dogs. Insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks. Newly arriving fleas are killed within 48 hours of landing on the animal. 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. The product has not demonstrated an immediate acaricidal effect against ticks but has demonstrated persistent acaricidal efficacy for up to 4 weeks against _Rhipicephalus sanguineus and_ _ Dermacentor reticulatus_ and up to 3 weeks against _Ixodes Ricinus._ If ticks of these species are present when the product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week. 4.3 CONTRAINDICATIONS Do not use on puppies less than 8 weeks old and/or weighing less than 2 kg in the absence of available data. Do not use on sick (systemic diseases, fever…) or convalescent animals. Revised: September 2018 AN: 00540/2018 Page 2 of 6 Do not use in rabbits, as adverse drug reactions and even death could occur. Do not use in case of hypersensitivity to fipronil or to any of the excipients. Do not administer orally. This product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing. 4.4 SPECIAL WARNINGS FOR EACH TARGET S Izlasiet visu dokumentu