Bravecto Spot On Dogs

For the treatment and prevention of tick, flea and mite infestations in dogs and cats.

Bravecto^® Spot-On can be used as part of a treatment strategy for Flea Allergy Dermatitis (FAD). For the treatment of mange caused by Demodex spp. and Sarcoptes scabiei mites in dogs. For the treatment of Otodectes spp. mite infestations in dogs and cats.

In cats, Bravecto^® Spot-On provides immediate and persistent flea and tick killing activity for 3 months.

In dogs, Bravecto^® Spot-On provides immediate and persistent tick killing activity for 4 months and flea killing activity for 6 months. Bravecto^® Spot-On is well tolerated in MDR1 dogs.

A single treatment prevents Dipylidium caninum transmission from infected fleas to susceptible dogs for 12 weeks.

COMPOSITION

Each 1 m of Bravecto^® Spot-On contains 280 mg fluralaner.

Each pipette delivers:

CLINICAL PHARMACOLOGY

Peak fluralaner concentrations are achieved between 7 and 42 days following topical administration and the elimination half-life ranges between 14 and 29 days. The bioavailability of fluralaner following oral and topical administration is approximately 25 %.

PHARMACODYNAMIC PROPERTIES

Fluralaner is an acaricide and insecticide. It is efficacious against ticks, fleas and mites.

Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives.

Fluralaner is an inhibitor of parts of the arthropod nervous system. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor).

CAUTION

STORAGE INSTRUCTIONS

• Store at or below 30 °C in a cool, dry place.
• Store in the original package in order to protect from light.
• Do not use Bravecto^® Spot-On after the expiry date which is stated on the container label.

WARNINGS

• Handle with caution.
• For cats, safety has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
• For dogs infected with tapeworm, we recommend a suitable tapeworm treatment be used.
• Do not use in the case of hypersensitivity to the active substance or to any of the excipients.
• Parasites need to start feeding on the host to become exposed to fluralaner; therefore, the risk of the transmission of parasite-borne diseases cannot be excluded but is reduced by the speed of efficacy.
• Care should be taken to avoid contact with the eyes of the animal.
• Do not use directly on skin lesions.
• Dogs can be washed/shampooed 3 days after treatment.
• Safety in puppies less than 8 weeks old and/or dogs weighing less than 2 kg has not been established.
• Safety in kittens less than 9 weeks old and/or cats weighing less than 1,2 kg has not been established.
• Bravecto^® Spot-On should not be administered at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.
• Keep Bravecto^® Spot-On in the original packaging until use.
• Do not have contact with the animal or allow children to have contact with the animal until the application site is dry.
• Bravecto^® Spot-On is highly flammable. Keep away from heat, sparks, open flames or other sources of ignition.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

• For topical use only. Avoid oral ingestion.
• Do not eat, drink or smoke while handling the product.
• Wash hands thoroughly with soap and water immediately after the product has been used. If skin contact does occur, wash the affected area immediately with water. In some cases, water is not sufficient to remove the product spilled on the fingers. If a sticky residue persists on the skin after washing with water, then this can be removed using household items containing organic solvents [e.g., rubbing alcohol (ethanol, isopropyl alcohol) or nail polish remover (acetone)] applied gently with a swab.
• Do not store with food, drinks, medication or household products.
• Medicines should not be disposed of via wastewater or household waste but in accordance with the National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008). These measures should help to protect the environment.

INTERACTIONS

Fluralaner is highly bound to plasma proteins and might compete with other highly bound drugs 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 laboratory and clinical field testing, no interactions between Bravecto^® Spot-On and routinely used veterinary medicinal products were observed.

ADVERSE REACTIONS

Commonly observed adverse reactions in clinical trials were mild and transient skin reactions at the application site (1,2 % of treated dogs and 2,2 % of treated cats).

Cat's skin reactions were such as erythema and pruritus (most likely due to a transient discomfort) or alopecia (secondary effect due to scratching or licking). As a result of transient discomfort shortly after administration, the following signs were observed: apathy/tremors/anorexia (0,9 % of treated cats) or vomiting/hypersalivation (0,4 % of treated cats). Based on post-registration experience, convulsions have very rarely been reported, (less than 1 in 10 000 animals treated).

Emesis, lethargy, inappetence, muscle tremors, ataxia and convulsions have been reported very rarely in spontaneous reports after the use of this product (less than 1 animal in 10 000 animals treated).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinarian.

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