Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: 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Withdrawn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 Đọc toàn bộ tài liệu
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 Đọc toàn bộ tài liệu