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Clinical particulars
Target species:
Cats and Dogs.
Indications for use:
For the treatment of tick and flea infestations in cats and dogs.
Cats:
This veterinary medicinal product is a systemic insecticide and acaricide that provides immediate and persistent flea (Ctenocephalides felis) and tick (Ixodes ricinus) killing activity for 12 weeks.
Dogs:
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
immediate and persistent flea (Ctenocephalides felis and Ctenocephalides canis) killing activity for 12 weeks, and
immediate and persistent tick (Ixodes ricinus, Rhipicephalus sanguineus and Dermacentor reticulatus) killing activity for 12 weeks.
In both cats and dogs:
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Contraindications:
Do not use in case 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 veternary 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 shortr intervals has not been tested.
This product is for topical use and hsould 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 shorterly 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.
Amounts to be administered and administration route:
For spot-on use.
Cats:
Bravecto should be administered in accordance with the following table (corresponding to a dose of 40 - 94 mg fluralaner/kg body weight):
Bravecto Cat Dosage Guide
For cats above 12.5 kg body weight, use a combination of two pipettes that most closely matches the body weight.
Method of administration:
Step 1: Immediately before use, open the sachet and remove the pipette. Put on gloves. The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for opening it. The twist-and-use 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 the seal is felt.
Bravecto spot on cat
Step 2: The cat should be standing or lying with its back horizontal for easy application. Place the pipette tip on the base of the skull of the cat.
Step 3: Squeeze the pipette gently and apply the entire contents directly to the cat's skin. The product should be applied on cats up to 6.25 kg body weight in one spot at the base of the skull and in two spots on cats greater than 6.25 kg bodyweight.
cat1
Treatment Schedule:
For optimal control of tick and flea infestation, the product should be administered at intervals of 12 weeks.
Dogs:
Bravecto should be administered in accordance with the following table (corresponding to a dose of 25-56 mg fluralaner/kg body weight)
Bravecto Dog Dosage Guide
For dogs above 56 kg body weight, use a combination of two pipettes that most closely matches the body weight.
Method of administration to dogs:
Step 1: Immediately before use, open the sachet and remove the pipette. Put on gloves. The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for 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 the seal is felt.
Bravecto spot on
Step 2: The dog should be standing or lying with its back horizontal during application. Place the pipette tip vertically against the skin between the shoulder blades of the dog.
Step 3: Squeeze the pipette gently and apply the entire contents directly to the dog's skin in one (when volume is small) or several spots along the dog's dorsalline from the shoulder to the base of the tail. Avoid the application of more than 1 ml of solution at any oen spot as it could cause some of the solution to run or drip off the dog.
Bravecto Spot On Dog image
Treatment schedule:
For optimal control of tick and flea infestation, the product should be administered at intervals of 12 weeks.
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 bodyweight) 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 bodyweight). No treatment-related clinical signs were observed.
Withdrawal periods:
Not applicable.