Land: Tyskland
Språk: engelsk
Kilde: HMA (Heads of Medicines Agencies)
fipronil 50 mg/ml
Bob Martin (UK ) Ltd
QP53AX15
Spot-on solution
fipronil
Cats
2013-03-20
Revised: September 2013 AN: 00681/2012 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bob Martin Clear 50 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 50mg EXCIPIENTS: Butylhydroxyanisole E320 0.1mg Butylhydroxytoluene E321 0.05mg For a 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 Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea (Ctenocephalides spp.) infestations. Fleas will be killed within 24 h. The product has a persistent insecticidal efficacy for up to 5 weeks against fleas (Ctenocephalides spp.). Although no immediate killing effect against ticks has been demonstrated, the product has shown an acaricidal efficacy against Dermacentor reticulatus. If ticks of this species are present when the product is applied, all the ticks may not be killed within the first 48 hours but they will be killed within a week. 4.3 CONTRAINDICATIONS Do not use on kittens less than 2 months old and/or weighing less than 1 kg. Do not use on sick (systemic diseases, fever…) or convalescent animals. Do not use in rabbits, as adverse drug reactions and even death could occur. Revised: September 2013 AN: 00681/2012 Page 2 of 6 Do not use on animals with known hypersensitivity to the active substance or to any of excipients. 4.4 SPECIAL WARNINGS FOR EA Les hele dokumentet