Bravecto spot-on (2 - 4.5 kg)

1 x 1 pc

Spot-on, solution

Active substance

Fluralaner : 112,5 mg/pipette

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 and Ctenocephalides canis) killing activity for 12 weeks, and

- immediate and persistent tick (Ixodes ricinus, Rhipicephalus sanguineus and Dermacentor reticulatus) killing activity for 12 weeks.

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.

Dose to be administered and administration route

For spot-on use.

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

Body weight of dog (kg)	Strength and number of pipettes to be administered
Body weight of dog (kg)	Bravecto 112.5 mg	Bravecto 250 mg	Bravecto 500 mg	Bravecto 1000 mg	Bravecto 1400 mg
2 - 4.5	1
>4.5 - 10		1
>10 - 20			1
>20 - 40				1
>40 - 56					1

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

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

Method of administration

Step 1: Immediately before use, open the sachet and remove the pipette. Put on gloves. The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for opening it. The cap should be rotated clockwise or counter clockwise one full turn. The cap will stay on the pipette; it is not possible to remove it. The pipette is open and ready for application when the breaking of the seal is felt.

Step 2: The dog should be standing or lying with its back horizontal during application. Place the pipette tip vertically against the skin between the shoulder blades of the dog.

Step 3: Squeeze the pipette gently and apply the entire contents directly to the dog’s skin in one (when volume is small) or several spots along the dog’s dorsal line from the shoulder to the base of the tail. Avoid the application of more than 1 ml of solution at any one spot as it could cause some of the solution to run or drip off the dog.

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 tick and flea infestation, the veterinary medicinal product should be administered at intervals of 12 weeks.

For the treatment of Demodex canis mite infestations, a single dose of the veterinary medicinal product should be applied. 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 applied. The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.

Adverse reactions

Dog:

Common

(1 to 10 animals / 100 animals treated):

Skin reactions at the application site (such as Erythema, Alopecia) ^#

Very rare

(<1 animal / 10 000 animals treated, including isolated reports):

Lethargy, Anorexia

Emesis

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.