Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
fipronil, amitraz, (S)-methoprene
Merial
QP53AX65
fipronil / amitraz / (S)-methoprene
Dogs
Ectoparasiticides for topical use, incl. insecticides
Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis). Treatment of infestations by chewing lice (Trichodectes canis). Prevention of environmental flea contamination by inhibiting the development of all flea immature stages. The product can be used as part of a treatment strategy for the control of flea-allergy dermatitis. Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for five weeks by ticks and for up to five weeks by fleas.The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for four weeks.
Revision: 5
Withdrawn
2011-05-06
Medicinal product no longer authorised B. PACKAGE LEAFLET 21 Medicinal product no longer authorised PACKAGE LEAFLET FOR (Box of 3 pipettes) CERTIFECT 67 MG/ 60.3 MG/ 80 MG SPOT-ON SOLUTION FOR DOGS 2-10 KG CERTIFECT 134 MG/ 120.6 MG/ 160 MG SPOT-ON SOLUTION FOR DOGS 10-20 KG CERTIFECT 268 MG/ 241.2 MG/ 320 MG SPOT-ON SOLUTION FOR DOGS 20-40 KG CERTIFECT 402 MG/ 361.8 MG/ 480 MG SPOT-ON SOLUTION FOR DOGS 40-60 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: MERIAL 29, avenue Tony Garnier FR-69007 Lyon France. Manufacturer responsible for the batch release: MERIAL 4, Chemin du Calquet FR-31000 Toulouse Cedex France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Spot-on solution. Clear amber to yellowish solution. Each unit dose (dual cavity pipette) delivers: CERTIFECT spot-on solution Volume of unit dose (ml) Fipronil (mg) (S)-methoprene (mg) Amitraz (mg) dogs 2-10 kg 1.07 67.0 60.3 80.0 dogs 10-20 kg 2.14 134.0 120.6 160.0 dogs 20-40 kg 4.28 268.0 241.2 320.0 dogs 40-60 kg 6.42 402.0 361.8 480.0 Excipients essential for proper administration: butylhydroxyanisole (0.02 %) and butylhydroxytoluene (0.01 %). 22 Medicinal product no longer authorised 4. INDICATIONS Treatment and prevention of infestations in dogs by ticks ( _Ixodes ricinus, Dermacentor reticulatus, _ _Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, _ _Haemaphysalis longicornis, Amblyomma americanum _ and _Amblyomma maculatum) _ and fleas _(Ctenocephalides felis _ and _Ctenocephalides canis)._ Treatment of infestations by chewing lice ( _Trichodect Baca dokumen lengkap
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Each unit dose delivers: CERTIFECT spot-on solution Volume of unit dose (ml) Fipronil (mg) (S)-Methoprene (mg) Amitraz (mg) dogs 2-10 kg 1.07 67 60.3 80 dogs 10-20 kg 2.14 134 120.6 160 dogs 20-40 kg 4.28 268 241.2 320 dogs 40-60 kg 6.42 402 361.8 480 Excipients: Butylhydroxyanisole (0.02 %) Butylhydroxytoluene (0.01 %) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear amber to yellowish solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention of infestations in dogs by ticks ( _Ixodes ricinus, Dermacentor reticulatus, _ _Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, _ _Haemaphysalis longicornis, Amblyomma americanum _ and _Amblyomma maculatum) _ and fleas _(Ctenocephalides felis _ and _Ctenocephalides canis)._ Treatment of infestations by chewing lice ( _Trichodectes canis_ ). Prevention of environmental flea contamination by inhibiting the development of all flea immature stages. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for 5 weeks by ticks and for up to 5 weeks by fleas. 2 Medicinal product no longer authorised The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infect Baca dokumen lengkap