Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
pyriprole
Elanco GmbH
QP53AX26
pyriprole
Dogs
Ectoparasiticides for topical use, incl. insecticides
Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis) in dogs. Efficacy against new infestations with fleas persists for a minimum of 4 weeks.Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) in dogs. Efficacy against ticks persists for 4 weeks.
Revision: 10
Authorised
2006-12-18
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: PRAC-TIC 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: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer for the batch release: Elanco France S.A.S. 26, Rue de la Chapelle 68330 Huningue France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 56.25 mg spot-on solution for very small dogs Prac-tic 137.5 mg spot-on solution for small dogs Prac-tic 275 mg spot-on solution for medium dogs Prac-tic 625 mg spot-on solution for large dogs Pyriprole 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains 125 mg pyriprole as a colourless to yellow, clear solution for external application to the skin. One pipette delivers: UNIT DOSE PYRIPROLE Prac-tic for very small dogs 0.45 ml 56.25 mg Prac-tic for small dogs 1.1 ml 137.5 mg Prac-tic for medium dogs 2.2 ml 275 mg Prac-tic for large dogs 5.0 ml 625 mg The solution also contains 0.1 % Butylhydroxytoluene (E321) 35 4. INDICATION(S) Treatment and prevention of flea infestation ( _Ctenocephalides_ _canis and C. felis_ .). Treatment and prevention of tick infestation ( _Ixodes ricinus, Ixodes scapularis, Dermacentor _ _variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum_ ). Treatment and prevention of flea infestation: Prac-tic is effective against new infestations with fleas for a minimum duration of 4 weeks. Treatment and prevention of tick infestation: Prac-tic is effective against ticks for 4 weeks. 5. CONTRAINDICATIONS Do not use in dogs less than 8 weeks of age or weighing less than 2 kg. Do not use in case of known hypersensitivity to phenylpyrazole class compounds or to any of the excipients. Do not use on sick animals or on animals recovering from disease. The veterinary medicinal product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing. Do not use in rab Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 56.25 mg spot-on solution for very small dogs Prac-tic 137.5 mg spot-on solution for small dogs Prac-tic 275 mg spot-on solution for medium dogs Prac-tic 625 mg spot-on solution for large dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Pyriprole 125 mg One pipette delivers: UNIT DOSE PYRIPROLE Prac-tic for very small dogs 0.45 ml 56.25 mg Prac-tic for small dogs 1.1 ml 137.5 mg Prac-tic for medium dogs 2.2 ml 275 mg Prac-tic for large dogs 5.0 ml 625 mg EXCIPIENTS: 0.1% Butylhydroxytoluene (E321) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Colourless to yellow, clear spot-on solution for external application 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention of flea infestation ( _Ctenocephalides_ _canis and C. felis_ ) in dogs. Efficacy against new infestations with fleas persists for a minimum of 4 weeks. Treatment and prevention of tick infestation ( _Ixodes ricinus, Rhipicephalus sanguineus, Ixodes _ _scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum_ ) in dogs. Efficacy against ticks persists for 4 weeks. 3 4.3 CONTRAINDICATIONS Do not use in dogs less than 8 weeks of age or with a body weight of less than 2 kg. Do not use in cases of known hypersensitivity to phenylpyrazole class compounds or to any of the excipients. Do not use on sick (e.g. systemic diseases, fever) animals or animals recovering from disease. This veterinary medicinal product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing. Do not use in rabbits. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This veterinary medicinal product is for the treatment of ticks and adult fleas. All dogs in a household should be treated. In cases of heavy infestation prior to treatment, the dog’s surrounding should be vacuumed and treated with a suitable Lue koko asiakirja