Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
selamectin, sarolaner
Zoetis Belgium SA
QP54AA55
selamectin, sarolaner
Cats
Antiparasitic products, insecticides and repellents, Macrocyclic lactones, , combinations
For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm.The veterinary medicinal product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time.
Revision: 4
Authorised
2017-02-08
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET STRONGHOLD PLUS 15 MG/2.5 MG SPOT-ON SOLUTION FOR CATS ≤2.5 KG STRONGHOLD PLUS 30 MG/5 MG SPOT-ON SOLUTION FOR CATS >2.5–5 KG STRONGHOLD PLUS 60 MG/10 MG SPOT-ON SOLUTION FOR CATS >5–10 KG 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5–5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5–10 kg selamectin/sarolaner 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (pipette) delivers: ACTIVE SUBSTANCES: Stronghold Plus spot-on solution Total volume of unit dose (ml) selamectin (mg) sarolaner (mg) Cats ≤2.5 kg 0.25 15 2.5 Cats >2.5–5 kg 0.5 30 5 Cats >5–10 kg 1 60 10 EXCIPIENTS: 0.2 mg/ml butylhydroxytoluene. Spot-on solution. Clear, colourless to yellow solution. 4. INDICATION(S) For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time. ECTOPARASITES: - For the treatment and prevention of flea infestations ( _Ctenocephalides_ spp.). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks. The product kills adult fleas before they lay eggs for 5 weeks. Through its ovicidal and larvicidal action, the veterinary medicinal product may aid in the control of existing environmental flea infestations in areas to which the animal has access. - The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5–5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5–10 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: ACTIVE SUBSTANCES: Stronghold Plus spot-on solution Pipette content (ml) selamectin (mg) sarolaner (mg) Cats ≤2.5 kg 0.25 15 2.5 Cats >2.5–5 kg 0.5 30 5 Cats >5–10 kg 1 60 10 EXCIPIENTS: 0.2 mg/ml butylhydroxytoluene. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear, colourless to yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time. ECTOPARASITES: - For the treatment and prevention of flea infestations ( _Ctenocephalides_ spp.). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks. The product kills adult fleas before they lay eggs for 5 weeks. Through its ovicidal and larvicidal action, the veterinary medicinal product may aid in the control of existing environmental flea infestations in areas to which the animal has access. - The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). - Treatment of tick infestations. The veterinary medicinal product has immediate and persistent acaricidal effect for 5 weeks against _Ixodes ricinus _ and _Ixodes hexagonus_ , and 4 weeks against _Dermacentor reticulatus _ and _ Rhipicephalus sanguineus_ . - Treatment of ear mites ( _Otodectes cynotis_ ). - Treatment of biting lice infestations _(Felicola subrostratus Lesen Sie das vollständige Dokument