Bravecto 500mg - Chewable Antiparasitic Tablets for Dogs (10-20kg)

Bravecto – External antiparasitic for dogs in the form of chewable tablets.

Indications:

For the treatment of infestations with ticks and fleas in dogs.

This veterinary medicinal product is a systemic insecticide and acaricide that provides:

• Immediate and persistent killing activity against fleas (Ctenocephalides felis) for 12 weeks,
• Immediate and persistent killing activity against ticks for 12 weeks for Ixodes ricinus, Dermacentor reticulatus, and D. variabilis,
• Immediate and persistent killing activity against ticks for 8 weeks for Rhipicephalus sanguineus.

Fleas and ticks must be attached to the host and feed to be exposed to the active substance. The onset of effect is at 8 hours after attachment for fleas (C. felis) and 12 hours after attachment for ticks (I. ricinus).

The product can be used as part of a treatment strategy for controlling flea allergy dermatitis (FAD).

Each chewable tablet contains:

Chewable tablets come in different shades of brown with a smooth or slightly rough surface and a round shape. Marbling, spots, or both may be present.

Contraindications: Do not use in cases of hypersensitivity to the active substance or any of the excipients.

Adverse Reactions:

Common adverse reactions observed in clinical trials (1.6% of treated dogs) were mild and transient gastrointestinal effects such as diarrhea, vomiting, inappetence, and drooling.

The frequency of adverse reactions is defined using the following convention:

• Very common (more than 1 in 10 animals presenting adverse reactions during treatment)
• Common (more than 1 but less than 10 in 100 animals)
• Uncommon (more than 1 but less than 10 in 1,000 animals)
• Rare (more than 1 but less than 10 in 10,000 animals)
• Very rare (less than 1 animal in 10,000 animals, including isolated reports)

If you observe serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

Target Species: Dogs.

Forms:

• Bravecto 112.5 mg chewable tablets for very small dogs (2-4.5 kg)
• Bravecto 250 mg chewable tablets for small dogs (>4.5-10 kg)
• Bravecto 500 mg chewable tablets for medium dogs (>10-20 kg)
• Bravecto 1000 mg chewable tablets for large dogs (>20-40 kg)
• Bravecto 1400 mg chewable tablets for very large dogs (>40-56 kg)

Dosage for Each Species, Route of Administration, and Method of Administration:

For oral administration.

Bravecto should be administered according to the following table (corresponding to the dose of 25.56 mg fluralaner/kg body weight according to the weight band):

Recommendations for Proper Administration:

For dogs over 56 kg body weight, use a combination of two tablets that best fits the weight of the animal.
Chewable tablets should not be broken or divided.
Bravecto chewable tablets are to be administered at or around the feeding time.
Bravecto is a chewable tablet and is well accepted by most dogs. If the tablet is not willingly taken by the dog, it can also be given with food or directly in the oral cavity.
The dog should be observed during administration to confirm that the tablet is swallowed.

Treatment Regimen:

For optimal flea infestation control, the veterinary medicinal product can be administered at intervals of 12 weeks. For optimal tick infestation control, the timing of re-administration depends on the tick species. See section 4.

Waiting Time: Not applicable.

Special Storage Precautions:

Keep out of the sight and reach of children. Do not use this veterinary medicinal product after the expiry date marked on the label. The expiry date refers to the last day of the month.

Special Warnings:

Special warnings for each target species:

For parasites to be exposed to fluralaner, they must begin feeding on the host; therefore, the risk of transmission of infectious diseases cannot be excluded.

Special precautions for use in animals:

In the absence of available data, this veterinary medicinal product should not be used in puppies younger than 8 weeks and/or weighing less than 2 kg.

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

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Keep the product in the original packaging until use to prevent direct access of children to the product. Do not eat, drink, or smoke while handling the product.

Wash hands thoroughly with soap and water after using the product.

Use during pregnancy, lactation, or lay:

The safety of the veterinary medicinal product has been established during growth, pregnancy, and lactation. It can be used in breeding animals, in pregnant females, and during lactation.

Interactions with other medicinal products or other forms of interaction:

Not known.

Fluralaner binds to plasma proteins and may compete with other drugs with a high binding level, such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin.

Fluralaner incubation in the presence of carprofen or warfarin in plasma in dogs at expected peak plasma concentrations did not reduce protein binding of fluralaner, carprofen, or warfarin.

During clinical trials, no interactions were reported between Bravecto chewable tablets for dogs and routinely used veterinary medicinal products.

Special precautions for the disposal of unused products or waste, where appropriate:

Medicines should not be disposed of in wastewater or household waste.

Seek advice from your veterinarian on how to dispose of medicines that are no longer required. These measures contribute to the protection of the environment.

Other Information:

The product helps control flea populations in the environment in areas where treated dogs have access.

Cardboard box containing 1 aluminum blister sealed with paper foil/PET aluminum foil that contains 1 chewable tablet.