Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
afoxolaner, milbemycin oxime
Boehringer Ingelheim Vetmedica GmbH
QP54AB51
afoxolaner, milbemycin oxime
Dogs
Endectocides, Antiparasitic products, insecticides and repellents, milbemycin oxime, combinations
For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis). Treatment of demodicosis (caused by Demodex canis). Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis). Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration. Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.
Revision: 9
Authorised
2015-01-15
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: NEXGARD SPECTRA 9 MG / 2 MG CHEWABLE TABLETS FOR DOGS 2–3.5 KG NEXGARD SPECTRA 19 MG / 4 MG CHEWABLE TABLETS FOR DOGS > 3.5–7.5 KG NEXGARD SPECTRA 38 MG / 8 MG CHEWABLE TABLETS FOR DOGS >7.5–15 KG NEXGARD SPECTRA 75 MG / 15 MG CHEWABLE TABLETS FOR DOGS >15–30 KG NEXGARD SPECTRA 150 MG / 30 MG CHEWABLE TABLETS FOR DOGS >30–60 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: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS, 4 Chemin du Calquet, 31000 Toulouse, FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2–3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5–7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5–15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15–30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30–60 kg Afoxolaner, milbemycin oxime 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains the active substances: NEXGARD SPECTRA Afoxolaner (mg) Milbemycin oxime (mg) chewable tablets for dogs 2–3.5 kg 9.375 1.875 chewable tablets for dogs >3.5–7.5 kg 18.75 3.75 chewable tablets for dogs >7.5–15 kg 37.50 7.50 chewable tablets for dogs >15–30 kg 75.00 15.00 chewable tablets for dogs >30–60 kg 150.00 30.00 Mottled red to reddish brown, circular shaped (tablets for dogs 2–3.5 kg) or rectangular shaped (tablets for dogs >3.5–7.5 kg, tablets for dogs >7.5–15 kg, tablets for dogs >15–30 kg and tablets for dogs >30-60 kg). 19 4. INDICATION(S) For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease ( _Dirofilaria immitis _ larvae), _angiostrongylosis _ (reduction in level of immature adults (L5) Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2–3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5–7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5–15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15–30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30–60 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCES: NEXGARD SPECTRA Afoxolaner (mg) Milbemycin oxime (mg) chewable tablets for dogs 2–3.5 kg 9.375 1.875 chewable tablets for dogs >3.5–7.5 kg 18.75 3.75 chewable tablets for dogs >7.5–15 kg 37.50 7.50 chewable tablets for dogs >15–30 kg 75.00 15.00 chewable tablets for dogs >30–60 kg 150.00 30.00 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets Mottled red to reddish brown, circular shaped (tablets for dogs 2–3.5 kg) or rectangular shaped (tablets for dogs >3.5–7.5 kg, tablets for dogs >7.5–15 kg, tablets for dogs >15–30 kg and tablets for dogs >30-60 kg). 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease ( _Dirofilaria immitis_ larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of _Angiostrongylus vasorum_ ), thelaziosis (adult _Thelazia callipaeda_ ) and/or treatment of gastrointestinal nematode infestations is indicated. Treatment of flea infestations ( _Ctenocephalides felis _ and _ C. canis_ ) in dogs for 5 weeks. Treatment of tick infestations ( _Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, _ _Rhipicephalus sanguineus_ ) in dogs for 4 weeks. Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. 3 Treatment of infestations with adult gastrointestinal nematodes of the following speci Soma hati kamili