Nexgard

INDICATIONS - Treatment of flea infestations in dogs (Ctenocephalides felis and C. canis) for a minimum of 5 weeks. The product may be part of a treatment strategy for the control of flea allergy dermatitis (FAD). Treatment of tick infestations in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus). One treatment kills ticks for up to 1 month. Fleas and ticks must be attached to the host and begin feeding to be exposed to the active substance. For fleas (C. felis), onset of effect occurs within 8 hours of attachment. For ticks, onset of effect (death) occurs within 48 hours of attachment.

NexGard chewable tablets

11 mg for dogs 2-4 kg;

28 mg for dogs >4-10 kg;

68 mg for dogs >10-25 kg;

136 mg for dogs >25-50 kg
ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each chewable tablet contains:

Excipient: Potassium sorbate (E202): 0.3 mg /g

CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS None. If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

ROUTE AND METHOD OF ADMINISTRATION Oral administration.

Dosage: The product should be administered at a dose of 2.7-6.9 mg/kg body weight according to the following table:

For dogs over 50 kg body weight, the necessary combination of chewable tablets of different or the same strengths should be used. The tablets should not be divided. Treatment regimen: The treatment is repeated at monthly intervals throughout the periods conducive to the development of fleas and/or ticks, depending on the local epidemiological situation.

RECOMMENDATIONS ON CORRECT ADMINISTRATION The tablets are chewable and palatable to most dogs. If the dog does not accept the tablets directly, they can be administered with food. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. This medicinal product does not require any special temperature storage conditions.

SPECIAL WARNINGS

Special warnings for each target species: Parasites must start feeding on the host to be exposed to afoxolaner; therefore the risk of transmission of infectious diseases cannot be excluded.

Special precautions for use in animals In the absence of available data, the treatment of puppies less than 8 weeks of age and/or dogs weighing less than 2 kg should only be carried out based on a benefit/risk assessment by the veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals Remove one tablet from the blister and return the blister with the remaining tablets to the carton to prevent direct access of children to the veterinary medicinal product. Wash hands thoroughly after use.

Pregnancy and lactation: Laboratory studies in rats and rabbits have not shown 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 according to the benefit/risk assessment of the veterinarian.

Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age treated with 5 times the maximum dose repeated 6 times at intervals of 2 to 4 weeks. Diarrhoea and vomiting have been observed at approximately 5 x overdose (25 mg/kg body weight) in Collies.

DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Ask your veterinary surgeon how to dispose of medicines no longer required. These measures will help protect the environment.

Detailed information on this product is available on the website of the European Medicines Agency.

OTHER INFORMATION

Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.

NexGard is active against adult fleas as well as tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.

The product kills fleas before they lay eggs and thus prevents contamination of the home.

Chewable tablets are available for each strength in the following pack sizes: Cardboard box with a blister of 1 chewable tablet, 3 or 6 chewable tablets.