Contraindications
Do not use in cases 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
Cats:
Care should be taken to avoid contact with the eyes of the animal.
Do not use directly on skin lesions.
In the absence of available data, this veterinary medicinal product should not be used on kitten less than 11 weeks old and/or cats weighing less than 1.2 kg.
The product should not be administered at intervals shorter than 8 weeks as the safety at shorter intervals has not been tested.
This product is for topical use and should not be administered orally.
Do not allow recently treated animals to groom each other.
Dogs:
Care should be taken to avoid contact with the eyes of the animal.
Do not use directly on skin lesions.
Do not wash or allow the dog to become immersed in water or swim in water courses within 3 days after treatment.
In the absence of available data, this veterinary medicinal product should not be used on puppies less than 8 weeks old and/or dogs weighing less than 2kg.
The product should not be administered at intervals shorter than 8 weeks as the safety at short intervals has not been tested.
This product is for topical use and should not be administered orally.

Operator warnings
This product is harmful after ingestion. Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product. A used pipette should immediately be disposed of. In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
The product binds to skin and may also bind to surfaces after spillage of the product.
Skin rashes tingling or numbness have been reported in a small number of individuals after skin contact. Contact may occur either directly, when handling the product, or when handling the treated animal. In order to avoid contact, disposable protective gloves provided with this product must be worn when handling and administering the product.
If skin contact does occur, wash the affected area immediately with soap and water. In some cases, soap and water is not sufficient to remove the product spilled on the fingers, therefore gloves must be used.
Make sure that your animal's application site is no longer noticeable before resuming contact with the site of application. This includes cuddling the animal and sharing a bed with the animal. It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
If skin reactions occur, consult a physician and show them the product packaging.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.
In case of spillage onto, for example table or floor surfaces, remove excess product using paper tissue and clean the area with detergent.
Hypersensitivity reactions to the product have been reported in a small number of people. The product should not be used by persons with a hypersensitivity to the active substance or to any of the excipients (see contraindications, section 4.3). People with a sensitive skin or known allergy in general e.g. to other veterinary medicinal products of this type should handle the veterinary medicinal product as well as treated animals with caution.

Adverse Reactions
Cats:
Mild and transient skin reactions at the application site, such as erythema and pruritus or alopecia were commonly observed in clinical trials (2.2% of treated cats).
The following other signs shortly after administration were observed:
apathy/tremors/anorexia (0.9% of treated cats) or vomiting/hypersalivation (0.4% of treated cats).
Dogs:
Mild and transient skin reactions such as erythema or alopecia at the application site were commonly observed in clinical trials (1.2% of treated dogs).
Cats and Dogs:
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Use during pregnancy or lactation
Cats:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Dogs:
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 medicinal products such as non-steroidal and 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 solution for dogs or cats and routinely used veterinary medicinal products were observed.

Overdose
Cats:
No adverse reactions were observed following topical administration to kittens aged 11 - 13 weeks and weighing 1.2 - 1.5 kg treated with overdoses of up to 5 times the maximum recommended dose (93 mg, 279 mg and 465 mg fluralaner/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).
Oral uptake of the product at the maximum recommended dose of 93 mg fluralaner/kg body weight was well tolerated in cats, apart from some self-limiting salivation and coughing or vomiting immediately after administration.
Dogs:
No adverse reactions were observed following topical administration to puppies aged 8 – 9 weeks and weighing 2.0 – 3.7 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).
There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg body weight of fluralaner).
Fluralaner was well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the maximum recommended dose (168 mg/kg body weight). No treatment-related clinical signs were observed.

Withdrawal periods
Not applicable.