Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
indoxacarb, permethrin
Intervet International BV
QP53AC54
indoxacarb, permethrin
Dogs
permethrin, combinations, Ectoparasiticides for topical use, incl. insecticides
Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis. The product has persistent acaricidal efficacy for up to 5 weeks against Ixodes ricinus and up to 3 weeks against Rhipicephalus sanguineus. One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.,
Revision: 9
Withdrawn
2012-01-09
18 B. PACKAGE LEAFLET Medicinal product no longer authorised 19 PACKAGE LEAFLET: ACTIVYL TICK PLUS SPOT-ON SOLUTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer responsible for batch release: Intervet Productions SA Rue de Lyons 27460 Igoville France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs Indoxacarb + permethrin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCES: One ml contains 150 mg indoxacarb and 480 mg permethrin. One pipette delivers: VOLUME (ML) INDOXACARB (MG) PERMETHRIN (MG) For very small dogs (1.2 – 5 kg) 0.5 75 240 For small dogs (5.1 – 10 kg) 1 150 480 For medium dogs (10.1 – 20 kg) 2 300 960 For large dogs (20.1 – 40 kg) 4 600 1920 For extra large dogs (40.1 – 60 kg) 6 900 2880 A clear, colourless to yellow or brown-coloured solution. 4. INDICATION(S) Treatment of flea infestations ( _Ctenocephalides felis_ ); the product has persistent insecticidal efficacy for up to 4 weeks against _Ctenocephalides felis_ . The product has persistent acaricidal efficacy for up to 5 weeks against _Ixodes ricinus _ and up to 3 weeks against _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. Developing stages of fleas in the dog’s immediate surroundings are killed following contact with the Medicinal product no longer authorised 20 treated dogs. One treatment p Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: One ml contains 150 mg indoxacarb and 480 mg permethrin. One unit dose pipette delivers: VOLUME OF UNIT DOSE (ML) INDOXACARB (MG) PERMETHRIN (MG) Very small dogs (1.2 - 5 kg) 0.5 75 240 Small dogs (5.1 - 10 kg) 1 150 480 Medium dogs (10.1 - 20 kg) 2 300 960 Large dogs (20.1 - 40 kg) 4 600 1920 Extra large dogs (40.1 - 60 kg) 6 900 2880 EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. A clear, colourless to yellow or brown-coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea infestations ( _Ctenocephalides felis_ ); the product has persistent insecticidal efficacy for up to 4 weeks against _Ctenocephalides felis_ . The product has persistent acaricidal efficacy for up to 5 weeks against _Ixodes ricinus _ and up to 3 weeks against _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. Developing stages of fleas in the dog’s immediate surroundings are killed following contact with the treated dogs. One treatment provides repellent (anti-feeding) activity against sand flies ( _Phlebotomus perniciosus_ ) for up to 3 weeks. Medicinal product no longer authorised 3 4.3 CONTRAINDICATIONS Do not use in cats as adverse reactions and even death can occur (see also section 4.5 Special precautions for use in animals). Do not Прочитать полный документ