Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Fipronil
Krka d.d., Novo Mesto
QP53AX15
Fipronil
Cutaneous spray, solution
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Ectoparasiticide
Expired
2015-09-30
Issued: September 2015 AN: 01274/2014 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fipronil KRKA 2.5 mg/ml cutaneous spray, solution for cats and dogs (UK) Fypryst 2.5 mg/ml cutaneous spray, solution for cats and dogs (CZ) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains ACTIVE SUBSTANCE: Fipronil 2.5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, solution Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs. 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES Treatment of flea (_Ctenocephalides_ spp.) and tick (_Ixodes ricinus_, _Rhipicephalus _ _sanguineus_) infestations in dogs and cats. Treatment of biting lice infestations in dogs (_Trichodectes canis_) and cats (_Felicola _ _subrostratus_). The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). Insecticidal efficacy against new infestations with adult fleas persists for up to 2 months in cats and up to 3 months in dogs, depending on environmental challenge. The product has a persistent acaricidal efficacy for up to 4 weeks against ticks, depending on the level of environmental challenge. 4.3 CONTRAINDICATIONS Do not use on sick (systemic diseases, fever) or convalescent animals Do not use in rabbits, as adverse reactions and even death could occur. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Issued: September 2015 AN: 01274/2014 Page 2 of 7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES When used as part of a strategy for the treatment of flea allergy dermatitis, monthly applications to the allergic patient and to other cats and dogs in the household are recommended. Treatment of bedding, carpets and soft furnishings with a suitable insecticide will aid reduction in environmental challenge and maximise the duration of protection against re-infestation provided by the product. The product is not suitable for direct trea Read the complete document