Valsts: Austrija
Valoda: angļu
Klimata pārmaiņas: HMA (Heads of Medicines Agencies)
fipronil 67 mg
Chanelle Pharmaceutical Manufacturing Ltd
QP53AX65
Spot-on solution
Fipronil, combinations
Dogs
2011-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Controline 50 mg Spot-on Solution for Cats. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 50 mg EXCIPIENTS: Butylhydroxyanisole E320 0.1 mg Butylhydroxytoluene E321 0.05 mg 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. The product has a persistent insecticidal efficacy for up to 5 weeks against fleas (_Ctenocephalides _spp.). The product has not demonstrated an immediate acaricidal effect against ticks but has demonstrated persistent acaricidal efficacy for up to 2 weeks against _Ixodes ricinus _and 1 week against _Dermacentor reticulatus _and _Rhipicephalus sanguineus. _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. The product can be used as part of a treatment strategy for Flea Allergic Dermatitis, where this has been previously diagnosed by a veterinary surgeon. 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used 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. Do not use in cases of hypersensitivity to the active substance or to any of excipients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/02/2012_ _CRN 7009874 Izlasiet visu dokumentu