SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

NexGard 11 mg chewable tablets for dogs 2–4 kg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains:

Active substance:

NexGard	Afoxolaner (mg)
chewable tablets for dogs 2–4 kg	11.3

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.

Mottled red to reddish brown, circular shaped.

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, Hyalomma marginatum). 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).

Treatment of ear mite infestations (caused by Otodectes cynotis).

4.3 Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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 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.

Wash hands after handling the product.

4.6 Adverse reactions (frequency and seriousness)

Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, 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 treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Can be used in breeding, pregnant and lactating dogs.

The safety of the veterinary medicinal product has not been established in breeding males.

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males.

In breeding males, use only according to the benefit-risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

For oral use.

Dosage:

The product should be administered at a dose of 2.7–7 mg/kg bodyweight in accordance with the following table:

Bodyweight of dog (kg)	Strength and number of chewable tablets to be administered
	NexGard 11 mg	NexGard 28 mg	NexGard 68 mg	NexGard 136 mg
2–4	1
>4–10		1
>10–25			1
>25–50				1

For dogs above 50 kg bodyweight, use an appropriate combination of chewable tablets of different/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.

Treatment of ear mite infestations (caused byOtodectes 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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 two to four weeks.

4.11 Withdrawal period(s) Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for systemic use. ATC vet code: QP53BE01.

5.1 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 postsynaptic 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, Ixodes hexagonus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, Haemaphysalis longicornis, and Hyalomma marginatum.

NexGard kills fleas within 8 hours and ticks within 48h.

The product kills fleas before egg production and therefore prevents household contamination.

5.2 Pharmacokinetic particulars

After oral administration in dogs, afoxolaner was shown to have high systemic absorption following administration. The absolute bioavailability was 74 %. The mean maximum concentration (C_max) was 1,655 ± 332 ng/ml in plasma at 2–4 hours (T_max) after a 2.5 mg/kg afoxolaner dose.

Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/hr/kg. The terminal plasma half-life is approximately 2 weeks in most dogs; however, half-life of afoxolaner can differ between dogs (e.g. in one study, t_½ in Collies at 25 mg/kg bodyweight was up to 47.7 days) with no effect on safety. In-vitro experiments demonstrated that P-glycoprotein efflux does not occur, confirming that afoxolaner is not a substrate for the Pglycoprotein transporters.

Afoxolaner in the dog is metabolised to more hydrophilic compounds and then eliminated. The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile. No evidence of enterohepatic recycling has been observed.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize starch

Soy protein fines

Braised beef flavouring

Povidone (E1201)

Macrogol 400

Macrogol 4000

Macrogol 15 hydroxystearate

Glycerol (E422)

Medium-chain triglycerides 6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (PVC/Alu).

One carton contains 1 blister of 1, 3 or 6 chewable tablets or 3 blisters of 6 chewable tablets or 15 blisters of 1 chewable tablet. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

8. MARKETING AUTHORISATION NUMBER

Vm 04491/5027

9. DATE OF FIRST AUTHORISATION

11 February 2014

10. DATE OF REVISION OF THE TEXT

April 2023

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved 17 April 2023