Target species
Dogs
Indications for use for each target species
Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis). The veterinary medicinal product provides immediate and persistent killing activity 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, Hyalomma marginatum). The veterinary medicinal product provides immediate and persistent killing activity for 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).
Treatment of ear mite infestations (caused by Otodectes cynotis).
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
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.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.
The possibility that other animals in the same household can be a source of re-infestation with fleas, ticks or mites should be considered, and these should be treated as necessary with an appropriate product.
Special precautions for use
Special precautions for safe use in the target species:
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 veterinary medicinal product to animals:
To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister. Return the blister with the remaining chewable tablets into the carton. In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
Wash hands after handling the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorders1 (vomiting2, diarrhoea2) Lethargy2, anorexia2 Pruritus2 Neurological disorders (convulsion2, ataxia2, muscle tremor2). |
1 Mild.
2 Mostly self-limiting and of short duration.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used in pregnant and lactating dogs.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects.
Fertility:
Can be used in breeding females.
The safety of the veterinary medicinal product has not been established in breeding males. In breeding males, use only according to the benefit-risk assessment by the responsible veterinarian.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse reactions on the reproductive capacity of males.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Oral use.
Dosage:
The veterinary medicinal product should be administered at a dose of 2.7 to 7 mg/kg bodyweight of afoxolaner in accordance with the following table:
Bodyweight of dog (kg) | Strength and number of chewable tablets to be administered |
2 - 4 | 1 x NexGard 11 mg |
>4 - 10 | 1 x NexGard 28 mg |
>10 - 25 | 1 x NexGard 68 mg |
>25 - 50 | 1 x NexGard 136 mg |
For dogs above 50 kg bodyweight, use an appropriate combination of chewable tablets of different/same strengths.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The chewable tablets should not be divided. Underdosing could result in ineffective use and may favour resistance development.
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 and the animal’s lifestyle.
Treatment of demodicosis (caused by Demodex canis):
Monthly administration of the veterinary medicinal 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 veterinary medicinal product for two consecutive months. Further monthly administration may be required based on clinical assessment and skin scrapings.
Treatment of ear mite infestations (caused by Otodectes cynotis):
A single dose of the veterinary medicinal product should be administered. A further veterinary examination one month after the initial treatment is recommended as some animals may require a second treatment.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of 2 to 4 weeks.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.