Bravecto 1000 mg (20-40 kg) – one pipette

Name:
Bravecto 1000 mg – Spot-on pipette for dogs between 20 – 40 kg

Manufacturer:
MSD

Description:
Treatment against fleas and ticks in very small dogs (between 20 – 40 kg) offering protection for 12 weeks.

Ingredients:
Fluralaner 1000 mg.
Excipients: Dimethylacetamide, Glycofurol, Diethyltoluamide, Acetone.

Key benefits:
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 killing activity for fleas (Ctenocephalides felis) 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 Rhiphicephalus sanguineus.

Fleas and ticks must be attached to the host and feed in order to be exposed to the active substance. The onset of the effect is 8 hours after fixation for fleas (C. felis) and 12 hours after attachment for ticks (I. ricinus).
The product can be used as part of the treatment strategy for the control of flea allergic dermatitis (PAD).

Intended for:
Dogs between 20 and 40 kg.

Method of administration:
Dermal administration.
· Step 1: Immediately before use, open the sachet and remove the pipette. The pipette should be held by the base or the rigid upper portion under the cap in an upright position (tip up) to open it. The lid must be turned clockwise or counterclockwise for a full turn. The cap will remain on the pipette; secondment is not possible. The pipette is open and ready to apply when the seal is broken.
Bravecto spot on how to apply the pipette
· Step 2: The dog should stand or lie with its back horizontal during application. Place the tip of the pipette on the skin vertically, between the dog‘s shoulder blades.
· Step 3: Squeeze the pipette gently and apply the entire contents directly to the dog‘s skin in one (when the volume is small) or more points, along the dog‘s dorsal line from the shoulder blade to the base of the tail. Avoid applying an excessive amount of solution to one spot, as it could leak or drip off the dog.
Bravecto spot on how to apply the pipette according to the size of the dog

Form of presentation:
1 spot–on pipette.

Dosage:
1 spot–on pipette for dogs between 20 and 40 kg.
For optimal control of flea infestation, the veterinary medicinal product can be administered at 12–week intervals.
For optimal control of tick infestation, the timing of readministration depends on the tick species.

Possible side effects:
Common adverse reactions seen in clinical trials (1.6% of treated dogs) were mild and transient gastrointestinal effects such as diarrhoea, vomiting, loss of appetite and salivation.
If you notice any side effects, even those not already included in the package leaflet, or you think the medicine has had no effect, please inform your veterinarian.

Precautions:
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
To be exposed to fluralaner it is necessary for the parasites to start feeding on the host; Therefore, the risk of spreading communicable diseases cannot be excluded.
In the absence of available data, the veterinary medicinal product should not be used in puppies younger than 8 weeks of age and/or weighing less than 2 kg.

The product should not be taken at intervals of less than 8 weeks as the safety for shorter intervals has not been tested.
Fluralaner binds to plasma proteins and may compete with other drugs with high levels of binding, such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin.
Incubation of fluralaner in the presence of carprofen or warfarin in plasma in dogs at maximum predicted plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.
During clinical trials, there were no interactions between Bravecto for dogs and the routine veterinary medicinal products used.

How to store:
Store in a place away from moisture and direct exposure to the sun, at temperatures up to 25°C.

In case of overdose:
No adverse reactions were observed following oral administration in puppies 8–9 weeks of age 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) at intervals three times shorter than recommended (8–week intervals).
No conclusions were drawn on reproductive performance nor outcomes of interest on the viability of puppies after fluralaner was administered orally to Beagle dogs with overdoses up to 3 times the maximum recommended dose (up to 168 mg/kg fluralaner).
This veterinary medicinal product was well tolerated in Collie with a deficiency of drug resistance protein–1 (MDR1 –/–) after single oral administration of 3 times the recommended dose (168 mg/kg). No treatment–related clinical signs were observed.
In case of overdose, please contact your veterinarian urgently.