Bravecto 250 mg Chewable Tablets for Small Dogs (>4.5 – 10 kg)

Composition

Active substance:

Each chewable tablet contains:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Pork liver flavour

Sucrose

Maize starch

Sodium lauryl sulfate

Disodium pamoate monohydrate

Magnesium stearate

Aspartame

Glycerol

Soya-bean oil

Macrogol 3350

3

Pharmaceutical form

Chewable tablet.

Light to dark brown tablet with a smooth or slightly rough surface and circular shape. Some marbling, speckles or both may be visible.

3

Pharmacological properties

Pharmacotherapeutic group: Ectoparasiticides for systemic use.

ATCvet code: QP53BE02.

5.1 Pharmacodynamic properties

Fluralaner is an acaricide and insecticide. It is efficacious against ticks (Ixodes spp., Dermacentor spp. and Rhipicephalus sanguineus), fleas (Ctenocephalides spp.), Demodex canis mites and sarcoptic mange (Sarcoptes scabiei var. canis) on the dog.

Fluralaner reduces the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus by killing the ticks within 48 hours, before disease transmission occurs.

Fluralaner reduces the risk of infection with D. caninum via transmission by Ctenocephalides felis by killing the fleas before disease transmission occurs.

The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for I. ricinus and 48 hours for D. reticulatus ticks. The onset of acaricidal efficacy against I. hexagonus ticks was demonstrated 7 days after treatment.

Fluralaner has a high potency against ticks and fleas by exposure via feeding, i.e. it is systemically active on target parasites.

Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate- receptor).

In molecular on-target studies on insect GABA receptors of flea and fly, fluralaner is not affected by dieldrin resistance.

In in vitro bio-assays, fluralaner is not affected by proven field resistances against amidines (tick), organophosphates (tick, mite), cyclodienes (tick, flea, fly), macrocyclic lactones (sea lice), phenylpyrazoles (tick, flea), benzophenyl ureas (tick), pyrethroids (tick, mite) and carbamates (mite).

The veterinary medicinal product contributes towards the control of the environmental flea populations in areas to which treated dogs have access.

Newly emerged fleas on a dog are killed before viable eggs are produced. An in vitro study also demonstrated that very low concentrations of fluralaner stop the production of viable eggs by fleas.

The flea life cycle is broken due to the rapid onset of action and long-lasting efficacy against adult fleas on the animal and the absence of viable egg production.

5.2 Pharmacokinetic particulars

Following oral administration, fluralaner is readily absorbed reaching maximum plasma concentrations within 1 day. Food enhances the absorption. Fluralaner is systemically distributed and reaches the highest concentrations in fat, followed by liver, kidney and muscle. The prolonged persistence and slow elimination from plasma (t1/2 = 12 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval. Individual variation in Cmax and t1/2 was observed. The major route of elimination is the excretion of unchanged fluralaner in faeces (~90% of the dose). Renal clearance is the minor route of elimination.

3

Target species

Dogs.

3

Indications

For the treatment of tick and flea infestations in dogs.

This veterinary medicinal product is a systemic insecticide and acaricide that provides:

- immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks,

- immediate and persistent tick killing activity for 12 weeks for Ixodes ricinus, Dermacentor reticulatus and D. variabilis,

- immediate and persistent tick killing activity for 8 weeks for Rhipicephalus sanguineus,

- persistent tick killing activity from 7 days to 12 weeks after treatment for Ixodes hexagonus.

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

For the treatment of demodicosis caused by Demodex canis.

For the treatment of sarcoptic mange (Sarcoptes scabiei var. canis) infestation.

For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for up to 12 weeks. The effect is indirect due to the veterinary medicinal product’s activity against the vector.

For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for up to 12 weeks. The effect is indirect due to the veterinary medicinal product’s activity against the vector.

3

Dosage

For oral use.

The veterinary medicinal product should be administered in accordance with the following table (corresponding to a dose of 25 – 56 mg fluralaner/kg bodyweight within one weight band):

Strength and number of tablets to be administered

The chewable tablets should not be broken or divided.

For dogs above 56 kg body weight, use a combination of two tablets that most closely matches the bodyweight.

Underdosing could result in ineffective use and may favour resistance development.

Method of administration Administer the veterinary medicinal product at or around the time of feeding. The chewable tablet is well accepted by most dogs. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The dog should be observed during administration to confirm that the tablet is swallowed.

Treatment schedule For infestations with fleas and ticks, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.

For optimal control of flea infestation, the veterinary medicinal product should be administered at intervals of 12 weeks. For optimal control of tick infestation, the timing of retreatment depends on the tick species. See section 4.2.

For the treatment of Demodex canis mite infestations, a single dose of the veterinary medicinal product should be administered. As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately. For the treatment of sarcoptic mange infestations (Sarcoptes scabiei var. canis), a single dose of the veterinary medicinal product should be administered. The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.

3

Contraindications

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

3

Adverse reactions

Dogs:

Common (1 to 10 animals / 100 animals treated): Gastrointestinal effects (such as Anorexia, Hypersalivation, Diarrhoea, Emesis) #.

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Lethargy; Pruritus; Muscle tremor, Ataxia, Convulsion.

# mild and transient

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 also the last section of the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

Use with caution in dogs with pre-existing epilepsy.

In the absence of available data, the veterinary medicinal product should not be used on puppies less than 8 weeks old and /or dogs weighing less than 2 kg.

The veterinary medicinal product should not be administered at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Keep the veterinary medicinal product in the original packaging until use, in order to prevent children from getting direct access to the veterinary medicinal product. Hypersensitivity reactions in humans have been reported.

Do not eat, drink or smoke while handling the veterinary medicinal product.

Wash hands thoroughly with soap and water immediately after use of the veterinary medicinal product.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Not applicable.

3

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has been demonstrated. Can be used in breeding, pregnant and lactating dogs.

3

Interactions

Fluralaner is highly bound to plasma proteins and might compete with other highly bound active substances such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin. Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.

During clinical field testing, no interactions between the veterinary medicinal product and routinely used veterinary medicinal products were observed.

3

Overdose

No adverse reactions were observed following oral administration to puppies aged 8 – 9 weeks and weighing 2.0 – 3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).

There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg body weight of fluralaner).

The veterinary medicinal product was well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose (168 mg/kg body weight). No treatment-related clinical signs were observed.

3

Special warnings

Parasites need to start feeding on the host to become exposed to fluralaner; therefore the risk of the transmission of parasite borne diseases (including Babesia canis canis and D. caninum) cannot be completely 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 veterinary medicinal 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- infection with parasites should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Cardboard box with 1 aluminium foil blister sealed with PET aluminium foil lid stock containing 1, 2 or 4 chewable tablets.

Not all pack sizes may be marketed.

3

Storage

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

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as fluralaner may be dangerous for aquatic invertebrates.

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

3

Additional information

Vm 01708/5021

9 DATE OF FIRST AUTHORISATION

11 February 2014

10 DATE OF REVISION OF THE TEXT

July 2025

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 07 August 2025

3

Registration holder

MSD Animal Health UK Limited

Walton Manor

Walton

Milton Keynes

MK7 7AJ

3