Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Imidacloprid; Permethrin (Cis:Trans 40:60)
Elanco GmbH
QP53AC54
Imidacloprid; Permethrin (Cis:Trans 40:60)
100.0/500.0 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
permethrin, combinations
Authorised
2004-04-02
Health Products Regulatory Authority 18 March 2021 CRN009KPK Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Advantix Spot-on solution for dogs over 4 kg up to 10 kg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Each pipette of 1.0 ml contains: Imidacloprid: 100.0 mg Permethrin (40/60): 500.0 mg EXCIPIENT(S): Butylhydroxytoluene (E321): 1.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. Clear yellowish to brownish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (over 4 kg up to 10 kg). For dogs less than or equal to 4 kg or more than 10 kg body weight, use the appropriate Advantix Spot-on solution product (see section 4.9). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of flea (_Ctenocephalides canis_, _Ctenocephalides felis_) infestation. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). For the treatment of biting lice (_Trichodectes canis_). The product has persistent acaricidal and repellent efficacy against tick infestations (_Rhipicephalus sanguineus _and _Ixodes _ _ricinus _for four weeks, and _Dermacentor reticulatus _for three weeks)_._ By repelling and killing the tick vector _Rhipicephalus sanguineus, _the product reduces the likelihood of transmission of the pathogen _Ehrlichia canis, _thereby reducing the risk of canine ehrlichiosis. The reduction in risk has been shown in studies to commence from 3 days following application of the product and to persist for 4 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) activi Read the complete document