Bravecto 112.5mg Chewable Tablet for Toy Dogs 2 - 4.5kg (single tablet)

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.