Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
afoxolaner
Boehringer Ingelheim Vetmedica GmbH
QP53BE01
afoxolaner
Dogs
Isoxazolines, Ectoparasiticides for systemic use
Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus). One treatment kills ticks for up to one month.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. Treatment of demodicosis (caused by Demodex canis).Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Revision: 11
Authorised
2014-02-11
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: NEXGARD 11 MG CHEWABLE TABLETS FOR DOGS 2–4 KG NEXGARD 28 MG CHEWABLE TABLETS FOR DOGS >4–10 KG NEXGARD 68 MG CHEWABLE TABLETS FOR DOGS >10–25 KG NEXGARD 136 MG CHEWABLE TABLETS FOR DOGS >25–50 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 11 mg chewable tablets for dogs (2–4 kg) NexGard 28 mg chewable tablets for dogs (>4–10 kg) NexGard 68 mg chewable tablets for dogs (>10–25 kg) NexGard 136 mg chewable tablets for dogs (>25–50 kg) afoxolaner 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains: NexGard Afoxolaner (mg) chewable tablets for dogs 2–4 kg 11.3 chewable tablets for dogs >4–10 kg 28.3 chewable tablets for dogs >10–25 kg 68 chewable tablets for dogs >25–50 kg 136 Mottled red to reddish brown, circular shaped (tablets for dogs 2–4 kg), or rectangular shaped (tablets for dogs >4–10 kg, tablets for dogs >10–25 kg and tablets for dogs >25–50 kg). 4. INDICATIONS Treatment of flea infestation in dogs ( _Ctenocephalides felis _ and _ C. canis_ ) for at least 5 weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). Treatment of tick infestation in dogs ( _Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, _ _Rhipicephalus sanguineus). _ One treatment kills ticks for up to one month. Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. Treatment of demodicosis (caused by _Demodex canis_ ). 17 Treatment of sarcoptic mange (caused by _Sarcoptes scabiei _ var. _canis_ ). 5. CONTRAINDICATIONS Do not use Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NexGard 11 mg chewable tablets for dogs 2–4 kg NexGard 28 mg chewable tablets for dogs >4–10 kg NexGard 68 mg chewable tablets for dogs >10–25 kg NexGard 136 mg chewable tablets for dogs >25–50 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: NexGard Afoxolaner (mg) chewable tablets for dogs 2–4 kg 11.3 chewable tablets for dogs >4–10 kg 28.3 chewable tablets for dogs >10–25 kg 68 chewable tablets for dogs >25–50 kg 136 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 2–4 kg) or rectangular shaped (tablets for dogs >4–10 kg, tablets for dogs >10–25 kg and tablets for dogs >25–50 kg). 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea infestation in dogs ( _Ctenocephalides felis _ and _ C. canis_ ) for at least 5 weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). Treatment of tick infestation in dogs ( _Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, _ _Rhipicephalus sanguineus). _ One treatment kills ticks for up to one month. Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. Treatment of demodicosis (caused by _Demodex canis_ ). Treatment of sarcoptic mange (caused by _Sarcoptes scabiei _ var. _canis_ ). 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Parasites need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In the absence of available data, treatment of puppies les Lesen Sie das vollständige Dokument