Bravecto TriUNO Chewable Tablets for Dogs (> 2.5-5 kg)

Use of this combination veterinary medicinal product should be restricted to situations
where all active substances are necessary at the time of administration. In the absence
of a risk of co-infection with both ecto- and endoparasites, a narrow spectrum product
should be used.
Unnecessary use of antiparasitics or use deviating from the instructions given in the
SPC may increase the resistance selection pressure and lead to a reduction in
efficacy. In each individual animal the decision to use this veterinary medicinal
product should be based on confirmation of the parasitic species present and their
burden, or the risk of infestation/infection based on the epidemiological features of
the specific case.
Parasites need to start feeding on the host to become exposed to fluralaner; therefore,
the risk of the transmission of parasite borne diseases (including
and D. caninum) cannot be completely excluded.
Dogs in areas endemic for heartworm (or those which have travelled to endemic areas)
may be infected with adult heartworms. No therapeutic effect against adult
has been established. It is therefore recommended, in accordance with good veterinary
practice, that all animals 6 months of age or more, living in, or have travelled to, areas
where a vector exists, should be tested for existing adult heartworm infections before
beginning preventive use with the veterinary medicinal product.
Furthermore, it is essential that the guidance set out in section 3.9 (Amount(s) to be
administered and administration route) is followed closely and that there are no gaps
in product use for the prevention of heartworm disease while an animal is exposed to
the parasite’s vector.
For the treatment of infections with gastrointestinal nematodes the need for re-
treatment should be evaluated by the prescribing veterinarian. When re-treatment is
considered necessary, the choice of the treatment (monosubstance or combination
product) and the frequency of use should be determined by the responsible
veterinarian.
The possibility that other animals in the same household are a source of re-infection
with ticks, fleas or gastrointestinal nematodes should be considered, and these
animals should be treated as necessary with an appropriate product.

Special precautions for safe use in the target species:
In the absence of available data, treatment of puppies less than 8 weeks of age
should be based on a benefit-risk assessment by the responsible veterinarian.
In (MDR1-/-) dogs, the safety of the veterinary medicinal product was investigated in
a laboratory study following the administration of only a single dose. At a single
observation timepoint, depression was observed in one animal given the maximum
recommended dose. At 3 and 5 times the maximum recommended dose, depression
was observed in multiple animals in a dose-related manner. The recommended dose
should be strictly observed in MDR1 mutant (-/-) dogs with a non-functional P-
glycoprotein, which may include Collies and related breeds.
Use with caution in dogs with pre-existing epilepsy.
The veterinary medicinal product should not be administered at intervals shorter than
1 month as the safety at shorter intervals has not been tested.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Accidental ingestion of a tablet by a child may cause symptoms such as headache or
nausea.
Keep tablets in the original packaging until use in order to prevent children from
getting access to the product and ensure that if the tablet is administered via the
dog's feed, that it is fully consumed.
In case of accidental ingestion by a child, seek medical advice immediately and show
the package leaflet or the label to the physician.
The product may cause skin or eye irritation.
Should skin or eye irritation occur, rinse the affected area with water. If irritation
persists, seek medical advice.
Pyrantel may cause hypersensitivity reactions. People with sensitivity to pyrantel
should avoid contact with the product. If symptoms such as a skin rash occur, seek
medical advice.
Do not eat, drink, or smoke while handling the product.
Wash hands after use.
Special precautions for the protection of the environment:
The active substances, fluralaner and moxidectin, are mostly excreted in the faeces
and may be toxic to non-target organisms. In order to avoid contamination of the
environment, dog faeces should be bagged up and disposed of safely.