Bravecto 1400mg Chewable Tablet for Extra Large Dogs 40 - 56kg (single tablet)

 Fluralaner is an acaricide and insecticide. It is efficacious against ticks (Ixodes spp., Dermacentor spp. and Rhipicephalus sanguineus) and fleas (Ctenocephalides spp.) on the dog. It 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 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.

Active substances:
Fluralaner 1400 mg

Bravecto is a prescription product and must be applied according to the instructions by your veterinary surgeon.

Please read the product leaflet thoroughly before applying to your pet.

Marketing Authorisation Holder
Intervet International BV, The Netherlands

Marketing Authorisation Number
EU/2/13/158/013

Contra-indications

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

Special warnings for each target species

• 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.

Special precautions for use in animals

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

Operator warnings

• Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
• Do not eat, drink or smoke while handling the product.
• Wash hands thoroughly with soap and water immediately after use of the product.

Adverse reactions

• Commonly observed adverse reactions in clinical trials (1.6% of treated dogs) were mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling.
• The frequency of adverse reactions is defined using the following convention:
  - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
  - common (more than 1 but less than 10 animals in 100 animals)
  - uncommon (more than 1 but less than 10 animals in 1,000 animals)
  - rare (more than 1 but less than 10 animals in 10,000 animals)
  - very rare (less than 1 animal in 10,000 animals, including isolated reports).

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.

Interactions

• None known.

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 cumarin 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 Bravecto chewable tablets for dogs and routinely used veterinary medicinal products were observed.