Bravecto (2 - 4.5 kg)

1 x 1 pc

Chewable tablet

Active substance

Fluralaner : 112,5 mg

ATC code

QP53BE02 Fluralaner

QP53BE Isoxazolines

QP53B Ectoparasiticides for systemic use

QP53 Ectoparaciticides, insecticides and repellents

QP Antiparasitic products, insecticides and repellents

Species

Dog

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.

Dose to be administered and administration route

For oral use.

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

Bodyweight of dog (kg)	Strength and number of tablets to be administered
Bodyweight of dog (kg)	Bravecto 112.5 mg	Bravecto 250 mg	Bravecto 500 mg	Bravecto 1,000 mg	Bravecto 1,400 mg
2 – 4.5	1
>4.5 – 10		1
>10 – 20			1
>20 – 40				1
>40 – 56					1

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.

Method of administration

Administer Bravecto chewable tablets at or around the time of feeding.

Bravecto is a chewable tablet and 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 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 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 product should be administered. The need for and frequency of retreatment should be in accordance with the advice of the prescribing veterinarian.

Adverse reactions

Dog:

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;

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 the national competent authority via the national reporting system. See also section `Contact details` of the package leaflet.