Land: Verenigd Koninkrijk
Taal: Engels
Bron: VMD (Veterinary Medicines Directorate)
(S)-Methoprene, Fipronil
Ceva Animal Health Ltd
QP53AX65
(S)-Methoprene, Fipronil
Spot-on solution
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Ectoparasiticide
Expired
2014-05-07
Revised: September 2022 AN: 01491/2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Duoflect spot-on solution for dogs 10-20 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 1.4 ml pipette contains: ACTIVE SUBSTANCES: Fipronil 240 mg (S)-methoprene120 mg EXCIPIENTS: Butylhydroxyanisole E320 0.28 mg Butylhydroxytoluene E321 0.28 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 10-20 kg 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES - Treatment and prevention of flea and/or tick infestations. - Treatment and prevention of flea infestations (_Ctenocephalides _spp). Immediate insecticidal efficacy against new infestations with adult fleas persists for 9 weeks. Prevention of the multiplication of fleas by inhibiting the hatching of flea eggs (ovicidal activity) and the development of flea eggs into adult fleas for 8 weeks after application. - Treatment and prevention of tick infestation (_Dermacentor reticulatus_, _Rhipicephalus_ _sanguineus_). The product has immediate and persistent acaricidal efficacy for 6 weeks after application. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) in dogs when previously diagnosed by a veterinary surgeon. 4.3 CONTRAINDICATIONS Do not use in rabbits, as adverse reactions, even mortality, could occur. Revised: September 2022 AN: 01491/2022 Page 2 of 7 Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use on sick (e.g. systemic disease, fever) or convalescent animals. 4.4 SPECIAL WARNINGS The attachment of single ticks after treatment cannot be ruled out. Therefore the transmission of infectious disease cannot be completely excluded if conditions are unfavourable. All stages of fleas can infest the dog’s basket, bedding, and regular resting areas such as carpets and soft furnishings. In cases of massive flea in Lees het volledige document