NexGard Chewable Tablets for Dogs Species: Dogs Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs Active ingredient: Afoxolaner Product:NexGard Chewable Tablets for Dogs Product index: NexGard Qualitative and quantitative composition Active substance: Each chewable tablets contains: NexGard chewable tablets for dogs Afoxolaner (mg) (S) 2 - 4 kg 11.3 (M) >4 - 10 kg 28.3 (L) >10 - 25 kg 68.0 (XL) >25 - 50 kg 136.0 Excipient: Potassium sorbate (E202): 3 mg/g. For the full list of excipients, see Pharmaceutical particulars. Pharmaceutical form Chewable tablets. Mottled red to reddish brown, circular shaped (for dogs 2-4 kg) or rectangular shaped (for dogs >4-10 kg, >10-25 kg and >25-50 kg) tablets. Clinical particulars Target species Dogs Indications for 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 ricinis, 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). Contra-indications Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 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. Special precautions for use in animals In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian. Special precautions to be taken by the person administering the product to animals To prevent children from getting access to the product, remove only one chewable tablet at a time from the blister. Return the blister with the remaining chewable tablets into the carton. Wash hands after handling the product. Adverse reactions Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, or anorexia and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely. Most reported adverse reactions were self-limiting and of short duration. The frequency of adverse reactions is defined using the following convention: • very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) • common (more than 1 but less than 10 animals in 100 animals) • uncommon (more than 1 but less than 10 animals in 1,000 animals) • rare (more than 1 but less than 10 animals in 10,000 animals) • very rare (less than 1 animal in 10,000 animals, including isolated reports). Use during pregnancy, lactation or lay Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs. Use only according to the benefit-risk assessment by the responsible veterinarian. Interactions None known. Amounts to be administered and administration route For oral use only. Dosage: The product should be administered at a dose of 2.7- 7.0 mg/kg bodyweight in accordance with the following table: Weight (kg) Dosage 2 - 4 1 x NexGard (S) 11 mg tablet >4 - 10 1 x NexGard (M) 28 mg tablet >10 - 25 1 x NexGard (L) 68 mg tablet >25 - 50 1 x NexGard (XL) 136 mg tablet For dogs above 50 kg bodyweight, use an appropriate combination of chewable tablets of different/the same strengths. The tablets should not be divided. Method of administration: The tablets are chewable and palatable to most dogs. If the dog does not accept the tablets directly they may be administered with food. Treatment schedule: Treatment of flea and tick infestations: Monthly intervals throughout the flea and/or tick seasons, based on local epidemiological situations. Treatment of demodicosis (caused by Demodex canis): Monthly administration of the product until two negative skin scrapings are obtained one month apart. Severe cases may require prolonged monthly treatments. As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately. Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis): Monthly administration of the product for two consecutive months. Further monthly administration of the product may be required based on clinical assessment and skin scrapings. Overdose No adverse reactions were observed in healthy puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks. Pharmacodynamic properties Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family. Afoxolaner acts at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acarines. The selective toxicity of afoxolaner between insect/acarines and mammals may be inferred by the differential sensitivity of the insect/acarines’ GABA receptors versus mammalian receptors. Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis. NexGard kills fleas within 8 hours and ticks within 48 hours. The product kills fleas before egg production and therefore prevents household contamination. Pharmaceutical particulars Excipients Maize starch, Soy protein fines, Braised beef flavouring, Povidone (E1201), Macrogol 400, Macrogol 4000, Macrogol 15 hydroxystearate, Glycerol (E422), Medium-chain triglycerides. Major incompatibilities Not applicable. Shelf life Shelf life of the product as packaged for sale: 3 years Special precautions for storage This product does not require any special storage conditions. Immediate packaging The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (Aclar/PVC/Alu). One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet. Not all pack sizes may be marketed Disposal Any unused product or waste materials derived from it should be disposed of in accordance with local requirements. . Marketing Authorisation Holder (if different from distributor) Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany Marketing Authorisation Number UK(GB): NexGard 11 mg Chewable Tablets for Dogs 2-4 kg: Vm 04491/5027 NexGard 28 mg Chewable Tablets for Dogs >4-10 kg: Vm 04491/5029 NexGard 68 mg Chewable Tablets for Dogs >10-25 kg: Vm 04491/5030 NexGard 136 mg Chewable Tablets for Dogs >25-50 kg: Vm 04491/5028 UK(NI): EU/2/13/159/001-020 Significant changes Legal category Legal category: POM-V