Land: Storbritannien
Språk: engelska
Källa: VMD (Veterinary Medicines Directorate)
Fipronil, Pyriproxyfen
Alfamed
QP53AX65
Fipronil, Pyriproxyfen
Spot-on solution
POM-V - Prescription Only Medicine – Veterinarian
Cats
Ectoparasiticide; Insect Growth Regulator
Authorized
2019-04-30
Issued: April 2019 AN: 01257/2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ectoline duo 50 mg/60 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 ml pipette contains: ACTIVE SUBSTANCES: Fipronil 50 mg Pyriproxyfen 60 mg EXCIPIENTS: Butylhydroxyanisole E320 0.1 mg Butylhydroxytoluene E321 0.05 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear, colourless to yellowish solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cats, to be used against infestations with fleas alone or in association with ticks. Against fleas: Treatment and prevention of infestations by fleas _(Ctenocephalides felis)._ One treatment prevents further infestations for 5 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. Against ticks: Treatment of infestations by ticks (_Ixodes ricinus _and_ Rhipicephalus turanicus_). One treatment provides persistent acaricidal efficacy for one week. If ticks are present at the time of application, not all ticks may be killed within 48 hours. 4.3 CONTRAINDICATIONS Page 1 of 7 Issued: April 2019 AN: 01257/2018 Do not use in rabbits, as adverse reactions and even death could occur. Do not use in case of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Wetting of the haircoat with water 2 hours before product application and twice during the claimed period of efficacy against fleas (at two week intervals against adult fleas or four week intervals against developing flea stages) was investigated during two laboratory studies. Wetting of the haircoat with water as described did not adversely affect product effectivene Läs hela dokumentet