Bravecto Spot-On Flea & Tick Solution for Small Cats

Bravecto Spot-On Flea & Tick Solution for Small Cats is for the treatment and prevention of tick, flea and mite infestation in dogs and cats. Bravecto Spot On can be used as part of a treatment strategy for Flea Allergy Dermatitis (FAD). For the treatment of demodicosis caused by sarcoptic mange mite in dogs, for the treatment of Otodectes spp. mite infestations in dogs.

Bravecto Spot On For cats provides an immediate and persistent tick and flea activity for 3 months.

Bravecto Spot On For Dogs provides an immediate and persistent tick activity for 4 months and flea activity for 6 months.

Composition

Each ml of Bravecto Spot On contains 280mg fluralaner

Clinical Pharmacology

Peak fluralaner concentrations are achieved between 7 and 42 days following topical administration and the elimination half-life ranges between 14 and 29 days. The bioavailability of fluralaner following oral and topical administration is approximately 25%.

Pharmacodynamic Properties

Fluralaner is an acaricide and insecticide. It is efficacyious against ticks, fleas and mites. Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives. Fluralaner is an inhibitor of parts of the arthropod nervous system. The mode of action of fluralaner is the antagonistonism of the ligand-gated chloride channels (gamma-amenobuyotic acid (GABA)- receptor and glutamate-receptor).

Caution

Storage

Store at or below 30^oC in a cool dry place.

Warnings

Handle with caution
For cats, safety has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
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, but is reduced by the speed and efficacy.
Care should be taken to avoid contact with the eyes of the animal.
Do not use directly on skin lesions.
Dogs can be washed/shampooed 3 days after treatment.
Safety in puppies less than 8 weeks old and/or Dogs weighing less than 2kg has not been established.
Safety in kittens less than 11 weeks old and/or cats weighing less than 1.2kg has not been established.
The product should not be administered at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.
Keep the product in the original packaging before use.
Do not have contact with the animal or allow children to have contact with the animal until the application site is dry.
The product is highly flammable. Keep away from heat, sparks, open flames or other sources of ignition.
KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advised notify the registration holder.

Precautions

For topical use only. Avoid Oral ingestion.
Do not eat, drink or smoke while handling the product.
Wash hands thoroughly with soap and water immediately after the product has been used.
Do not store with foods, drinks, other medications and household products.
Medications should not be disposed of via wastewater or household waste but according to Environmental Waste Management Act. These measure should help protect the environment.

Interactions

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 coumarin derivative warfarin. Incubation of fluralaner in the presence of carpofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, Caprofen or warfarin.

During laboratory and clinical field testing, no interactions between Bravecto Spot-On and routinely used veterinary medical products were observed.

Adverse Reactions

Commonly observed adverse reactions in clinical trials were mild and transient skin reactions at the application site. (1.2% of treated dogs and 2.2% of treated cats) Cat’s skin reactions were such as erythema and proritus (most likely due to transient discomfort) or allpecia (secondary effect due to scratching or licking)

As a result od transient discomfort shortly after administration, the following signs were observed: apathy/tremors/anorexia (0.9% of treated cats) or vomiting/hypersalivation (0.4% of treated cats).

If you notice any serious effects or other effects not mentioned in the package leaflet, please inform your veterinarian.

Directions For Use

Bravecto Spot-On should be administered in accordance with the following table (corresponding to dose of between 25 and 56mg fluralaner/kg body weight in dogs and between 40 and 94mg fluralaner/kg body weight in cats within one weight band.

Weight of dog/cat (kg)	Pipette Size To Be Used	Volume (ml)	fluralaner (mg)
2 – 4.5	Miniature Dogs	0.4	112.5
4.5 – 10	Small Dogs	0.89	250
10 – 20	Medium Dogs	1.79	500
20 – 40	Large Dogs	3.57	1 000
40 – 56	Extra Large Dogs	5.0	1 400
Greater than 56kg	The appropriate combination of pipettes should be used.
1.2 – 2.8	Small Cats	0.4	112.5
2.8 – 6.25	Medium Cats	0.89	250
6.25 – 12.5	Large Cats	1.79	500

For optimal control of tick infestation, Bravecto Spot-On should be administered every 3 months for cats and every 4 months for dogs.

For optimal control of flea infestation, Bravecto Spot-On should be administered every 3 months for cats and every 6 months for dogs.

Within each weight range, a whole pipette must be used:

For dogs weighing more than 56kg use a combination of 2 pipettes that most closely matches the body weight.

For cats weighing more than 12,5kg use a combination of 2 pipettes that most closely matched the body weight.

Method Of Administration

Step 1:

Immediately before use, open the sachet and remove the pipette. The pipette should be held by the upper part of the tail base (crimped end) or by the upper rigid portion below the cap in the upright position (tip up) before opening it. The cap should be rotated clockwise or counter clockwise one full turn. The cap will stay on the pipette; it is not possible to remove it. The pipette is open and ready for application when the breaking of seal is felt.

Step 2:

The dog/cat should be standing or lying with its back horizontally during application. Part the fur at the administration site, place the pipette tip vertically against the skin between the shoulder blades of your dog or the pipette on the base of the skull on your cat.

Step 3:

Squeeze the pipette gently and apply the entire contents directly to your dogs skin in one (when volume is small) or several spots along your dogs dorsal line from the shoulder to the base of the tail. It should be avoided to apply an excessive amount of solution at any one spot that could cause some of the solution to run or drip off your dog.

Cats:

Squeeze the pipette gently and apply the entire contents directly to your cats skin. The product should be applied in one spot (cats up to 6.25kg body weight) or two spots on cats weighing more than 6.25kg. If two spots are needed, the first spot should be applied at the base of the skull and the second one between the shoulder blades.

It is important to deliver the solution onto an area that cannot be easily licked by your cat. As cats are fastidious groomers, they may inadvertently ingest the product if easily reached. If multiple cats are treated at the same time, it is advised that they are separated from one another until the product has dried.