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Date: Monday, June 24, 2024 16:11

Description: MSD-AH
Release 5.207
Bravecto® chewable tablets for dogs
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Fluralaner
Product:Bravecto® chewable tablets for dogs
Product index: Bravecto chewable tablets for dogs
Qualitative and quantitative composition
Each chewable tablet contains
Bravecto chewable tablets
Fluralaner (mg)
for very small dogs
(2- 4.5 kg)
for small dogs
(> 4.5 - 10 kg)
for medium-sized dogs
(> 10 - 20 kg)
for large dogs
(> 20 - 40 kg)
for very large dogs
(> 40 - 56 kg)
For the full list of excipients, see section "Pharmaceutical Particulars".
Pharmaceutical form
Chewable tablet.
Light to dark brown tablet with a smooth or slightly rough surface and circular shape. Some marbling, speckles or both may be visible.
Clinical particulars
Target species
Indications for use
For the treatment of tick and flea infestations in dogs.
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
- immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks,
- immediate and persistent tick killing activity for 12 weeks for Ixodes ricinus, Dermacentor reticulatus and D. variabilis,
- immediate and persistent tick killing activity for 8 weeks for Rhipicephalus sanguineus.
- persistent tick killing activity from 7 days to 12 weeks after treatment for Ixodes hexagonus.
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).
For the treatment of demodicosis caused by Demodex canis.
For the treatment of sarcoptic mange (Sarcoptes scabiei var. canis) infestation.
For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for up to 12 weeks. The effect is indirect due to product’s activity against the vector.
For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for up to 12 weeks. The effect is indirect due to product’s activity against the vector.
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 (including Babesia canis canis and D. caninum) cannot be completely excluded.
Special precautions for use
Use with caution in dogs with pre-existing epilepsy.
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.
Hypersensitivity reactions in humans have been reported.
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
Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).
Lethargy, muscle tremor, ataxia and convulsions have been reported very rarely in spontaneous reports.
Most reported adverse reactions were self-limiting and of short duration.
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
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.
Fluralaner is highly bound to plasma proteins and might compete with other highly bound active substances such as non-steroidal 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 clinical field testing, no interactions between Bravecto chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Amounts to be administered and administration route
For oral use.
Bravecto should be administered in accordance with the following table (corresponding to a dose of 25 – 56 mg fluralaner/kg body weight within one weight band):
Body weight of dog (kg)
Strength and number of tablets to be administered
Bravecto 112.5 mg
Bravecto 250 mg
Bravecto 500 mg
Bravecto 1000 mg
Bravecto 1400 mg
2 - 4.5
> 4.5 - 10
> 10 - 20
> 20 - 40
> 40 - 56
The chewable tablets should not be broken or divided.
For dogs above 56 kg body weight, use a combination of two tablets that most closely matches the bodyweight.
Method of administration
Administer Bravecto chewable tablets at or around the time of feeding.
Bravecto is a chewable tablet and is well accepted by most dogs. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The dog should be observed during administration to confirm that the tablet is swallowed.
Treatment schedule
For optimal control of flea infestation, the veterinary medicinal product should be administered at intervals of 12 weeks. For optimal control of tick infestation, the timing of retreatment depends on the tick species. See also section "Indications for use".
For the treatment of Demodex canis mite infestations, a single dose of the product should be administered. As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.
For the treatment of sarcoptic mange infestations (Sarcoptes scabiei var. canis), a single dose of the product should be administered. The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.
No adverse reactions were observed following oral administration to puppies aged 8 – 9 weeks and weighing 2.0 – 3.6 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).
The veterinary medicinal product was well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose (168 mg/kg body weight). No treatment-related clinical signs were observed.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATCvet code: QP53BE02.
Pharmacotherapeutic group
Ectoparasiticides for systemic use.
Fluralaner is an acaricide and insecticide. It is efficacious against ticks (Ixodes spp., Dermacentor spp. and Rhipicephalus sanguineus), fleas (Ctenocephalides spp.), Demodex canis mites and sarcoptic mange (Sarcoptes scabiei var. canis) on the dog.
Fluralaner reduces the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus by killing the ticks within 48 hours, before disease transmission occurs.
Fluralaner reduces the risk of infection with D. caninum via transmission of Ctenocephalides felis by killing the fleas before disease transmission occurs.
The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for I. ricinus and 48 hours for D. reticulatus ticks. The onset of acaricidal efficacy against I. hexagonus ticks was demonstrated 7 days after treatment.
Fluralaner has a high potency against ticks and fleas by exposure via feeding, i.e. it is systemically active on target parasites.
Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate-receptor).
In molecular on-target studies on insect GABA receptors of flea and fly, fluralaner is not affected by dieldrin resistance.
In in vitro bio-assays, fluralaner is not affected by proven field resistances against amidines (tick), organophosphates (tick, mite), cyclodienes (tick, flea, fly), macrocyclic lactones (sea lice), phenylpyrazoles (tick, flea), benzophenyl ureas (tick), pyrethroids (tick, mite) and carbamates (mite).
The product contributes towards the control of the environmental flea populations in areas to which treated dogs have access.
Newly emerged fleas on a dog are killed before viable eggs are produced. An in vitro study also demonstrated that very low concentrations of fluralaner stop the production of viable eggs by fleas.
The flea life cycle is broken due to the rapid onset of action and long-lasting efficacy against adult fleas on the animal and the absence of viable egg production.
Pharmacokinetic properties
Following oral administration, fluralaner is readily absorbed reaching maximum plasma concentrations within 1 day. Food enhances the absorption. Fluralaner is systemically distributed and reaches the highest concentrations in fat, followed by liver, kidney and muscle. The prolonged persistence and slow elimination from plasma (t1/2 = 12 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval. Individual variation in Cmax and t1/2 was observed. The major route of elimination is the excretion of unchanged fluralaner in faeces (~90% of the dose). Renal clearance is the minor route of elimination.
Pharmaceutical particulars
Pork liver flavour
Maize starch
Sodium lauryl sulfate
Disodium embonate monohydrate
Magnesium stearate
Soya-bean oil
Macrogol 3350
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Immediate packaging
Cardboard box with 1 aluminium foil blister sealed with PET aluminium foil lid stock containing 1, 2 or 4 chewable tablets.
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK(GB): 01708/5014, 16, 19, 21, 24
UK(NI): EU/2/13/158/001-2, 004-005, 007-008, 010-011, 013-014

Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 11 February 2014.
Date of last renewal: 05 February 2019.
Date of revision of the text
UK(GB): 18/11/2022
UK(NI): 18/07/2022.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN description:Bravecto 112.5 mg 1 x 1 tab:
GTIN description:Bravecto 112.5 mg 2 x 1 tab:
GTIN description:Bravecto 250 mg 1 x 1 tab:
GTIN description:Bravecto 250 mg 2 x 1 tab:
GTIN description:Bravecto 500 mg 1 x 1 tab:
GTIN description:Bravecto 500 mg 2 x 1 tab:
GTIN description:Bravecto 1000 mg 1 x 1 tab:
GTIN description:Bravecto 1000 mg 2 x 1 tab:
GTIN description:Bravecto 1400 mg 1 x 1 tab:
GTIN description:Bravecto 1400 mg 2 x 1 tab: