Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
spinosad
Elanco GmbH
QP53BX03
spinosad
Dogs; Cats
Other ectoparasiticides for systemic use
Treatment and prevention of flea infestations (Ctenocephalides felis).The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Revision: 12
Withdrawn
2011-02-11
18 B. PACKAGE LEAFLET Medicinal product no longer authorised 19 PACKAGE LEAFLET COMFORTIS 140 MG CHEWABLE TABLETS FOR DOGS AND CATS COMFORTIS 180 MG CHEWABLE TABLETS FOR DOGS AND CATS COMFORTIS 270 MG CHEWABLE TABLETS FOR DOGS AND CATS COMFORTIS 425 MG CHEWABLE TABLETS FOR DOGS AND CATS COMFORTIS 665 MG CHEWABLE TABLETS FOR DOGS COMFORTIS 1040 MG CHEWABLE TABLETS FOR DOGS COMFORTIS 1620 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: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer responsible for batch release: Elanco France S.A.S. 26 rue de la Chapelle 68330 Huningue France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs Comfortis 1040 mg chewable tablets for dogs Comfortis 1620 mg chewable tablets for dogs Spinosad 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains: ACTIVE SUBSTANCE: Comfortis 140 mg 140 mg spinosad Comfortis 180 mg 180 mg spinosad Comfortis 270 mg 270 mg spinosad Comfortis 425 mg 425 mg spinosad Comfortis 665 mg 665 mg spinosad Comfortis 1040 mg 1040 mg spinosad Comfortis 1620 mg 1620 mg spinosad Chewable tablets. Medicinal product no longer authorised 20 Tan to brown, or speckled with embedded darker particles, round, flat, bevelled edge tablets, plain on one side and debossed with a letter on the other side: 140 mg: C 180 mg: L 270 mg: J 425 mg: C 665 mg: J 1040 mg: L 1620 mg: J 4. INDICATION(S) Treatment and prevention of flea infestations ( _Ctenocephalides felis_ ). The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs. This activity persists for up Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs Comfortis 1040 mg chewable tablets for dogs Comfortis 1620 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Comfortis 140 mg spinosad 140 mg Comfortis 180 mg spinosad 180 mg Comfortis 270 mg spinosad 270 mg Comfortis 425 mg spinosad 425 mg Comfortis 665 mg spinosad 665 mg Comfortis 1040 mg spinosad 1040 mg Comfortis 1620 mg spinosad 1620 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets. Tan to brown, or speckled with embedded darker particles, round, flat, bevelled edge tablets plain on one side and debossed with a letter and a line above on the other side: 140 mg: C 180 mg: L 270 mg: J 425 mg: C 665 mg: J 1040 mg: L 1620 mg: J 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention of flea infestations ( _Ctenocephalides felis_ ). The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product. Medicinal product no longer authorised 3 The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). 4.3 CONTRAINDICATIONS Do not use in dogs or cats under 14 weeks of age. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The veterinary medicinal product should be administered with food or immediately after feeding. The duration of efficacy may be reduced if the dose is a Przeczytaj cały dokument