Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Permethrin; Imidacloprid
Krka, d.d., Novo mesto
QP53AC54
Permethrin; Imidacloprid
2000, 400 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
permethrin, combinations
Ectoparasiticide
Authorised
2015-10-30
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS CONFIDENTIAL 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4.0 ml pipette contains: ACTIVE SUBSTANCES: Permethrin 2000.0 mg Imidacloprid 400.0 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCt Butylhydroxytoluene (E321) 4.0 mg Triglycerides, Medium-Chain N-methylpyrrolidone 800.0 mg Citric acid (E330) Dimethyl sulfoxide Clear yellowish to brownish spot on solution 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment and prevention of flea (_Ctenocephalides felis_) infestation. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). The veterinary medicinal product has persistent acaricidal efficacy against tick infestations (_Rhipicephalus sanguineus_ and _Ixodes ricinus _ for four weeks, and _Dermacentor reticulatus _ for three weeks) and persistent repellent efficacy (_Ixodes ricinus_) for three weeks. Ticks already on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal. One treatment provides repellent (anti-feeding) activity against the sand fly_ Phlebotomus _ _perniciosus_ for three weeks and against the mosquito _Aedes aegypti_ from 7 days up to 14 days after treatment. CONFIDENTIAL Reduction of the risk of infection with _Leishmania infantum_ via transmission by sandflies (_Phlebotomus perniciosus_) for up to 3 weeks. The effect is indirect due to the veterinary medicinal product's act Lugege kogu dokumenti