Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
spinosad, milbemycin oxime
Eli Lilly and Company Limited
QP54AB51
spinosad, milbemycin oxime
Dogs
Antiparasitic products, insecticides and repellents, Endectocides
For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: prevention of heartworm disease (L3, L4 Dirofilaria immitis);prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum;treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult, L5) and adult Ancylostoma caninum), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis).
Revision: 4
Withdrawn
2013-09-19
Medicinal product no longer authorised 19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET FOR: TRIFEXIS 270 MG/4.5 MG CHEWABLE TABLETS FOR DOGS TRIFEXIS 425 MG/7.1 MG CHEWABLE TABLETS FOR DOGS TRIFEXIS 665 MG/11.1 MG CHEWABLE TABLETS FOR DOGS TRIFEXIS 1040 MG/17.4 MG CHEWABLE TABLETS FOR DOGS TRIFEXIS 1620 MG/27 MG CHEWABLE TABLETS 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: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Manufacturer responsible for batch release: Eli Lilly and Company Ltd Speke Operations Fleming Road Liverpool L24 9LN UNITED KINGDOM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 – 6.0 kg) Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 – 9.4 kg) Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 – 14.7 kg) Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 – 23.1 kg) Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 – 36.0 kg) spinosad / milbemycin oxime 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCES: Each tablet contains: Trifexis 270 mg/4.5 mg spinosad 270 mg/milbemycin oxime 4.5 mg Trifexis 425 mg/7.1 mg spinosad 425 mg/milbemycin oxime 7.1 mg Trifexis 665 mg/11.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg Trifexis 1040 mg/17.4 mg spinosad 1040 mg/milbemycin oxime 17.4 mg Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemycin oxime 27.0 mg The tablets are a mottled tan to brown colour, and are round and chewable. The following list shows the code and the number of dimples marked on each strength of tablet: Trifexis 270 mg/4.5 mg tablets: 4333 and 2 dimples Trifexis 425 mg/7.1 mg tablets: 4346 and 3 dimples Trifexis 665 mg/11.1 mg tablets: 4347 and no dimples Medicinal product no longer authorised 21 Trifexis 1040 mg/17.4 mg tablets: 4349 and 4 dimpl Прочетете целия документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 – 6.0 kg) Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 – 9.4 kg) Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 – 14.7 kg) Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 – 23.1 kg) Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 – 36.0 kg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Each tablet contains: Spinosad Milbemycin oxime Trifexis 270 mg/4.5 mg 270 mg 4.5 mg Trifexis 425 mg/7.1 mg 425 mg 7.1 mg Trifexis 665 mg/11.1 mg 665 mg 11.1 mg Trifexis 1040 mg/17.4 mg 1040 mg 17.4 mg Trifexis 1620 mg/27 mg 1620 mg 27.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets. Mottled tan to brown, round, biconvex tablets with a debossed code on one side and dimples on the other side. The following list shows the code and the number of dimples marked on each strength of tablet: Trifexis 270 mg/4.5 mg tablets: 4333 and 2 dimples Trifexis 425 mg/7.1 mg tablets: 4346 and 3 dimples Trifexis 665 mg/11.1 mg tablets: 4347 and no dimples Trifexis 1040 mg/17.4 mg tablets: 4349 and 4 dimples Trifexis 1620 mg/27 mg tablets: 4336 and 5 dimples 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of flea ( _Ctenocephalides felis_ ) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 _Dirofilaria immitis_ ), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) _Angiostrongylus vasorum,_ - treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult (L5) and adult _Ancylostoma caninum_ ), roundworms (immature adult L5, and adult _Toxocara canis _ and adult _Toxascaris leonina_ ) and Прочетете целия документ