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Bravecto Chewable Tablets contain fluranaler and are used in dogs to control fleas and ticks. One dose is effective for 12 weeks against fleas and most types of tick. Bravecto can be given safely to breeding dogs, including pregnant or lactating bitches. It can be given to puppies from 8 weeks of age. The tablets should not be broken prior to dosing and are best given with food.
Bravecto is only effective once the parasite has bitten the dog and taken some blood. Therefore in a heavily infested environment, newly attached parasites might be seen briefly before they die. Newly emerged fleas will be killed before they are mature enough to lay eggs, so the life cycle of the flea is effectively stopped, so contributing to the control of the background environmental flea population.
Bravecto® chewable tablets for dogs
Each chewable tablet contains:
Bravecto chewable tablets
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”.
Light to dark brown tablet with a smooth or slightly rough surface and circular shape. Some marbling, speckles or both may be visible.
Indications for use, specifying the target species
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.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus).
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Do not use in case 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
Special precautions for use in animals
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
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 (frequency and seriousness)
Commonly observed adverse reactions in clinical trials (1.6% of treated dogs) were mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
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.
Interaction with other medicinal products and other forms of interaction
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 cumarin 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 bodyweight within one weight band):
Bodyweight 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
The chewable tablets should not be broken or divided.
For dogs above 56 kg bodyweight, 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.
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 section 4.2.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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 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 bodyweight 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 bodyweight). No treatment-related clinical signs were observed.
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
ATCvet code: QP53BX05.
Fluralaner is an acaricide and insecticide. It is efficacious against ticks (Ixodes spp., Dermacentor spp. and Rhipicephalus sanguineus) and fleas (Ctenocephalides spp.) on the dog.
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.
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.
List of excipients
Pork liver flavour, Sucrose, Maize starch, Sodium lauryl sulphate, Disodium embonate monohydrate, Magnesium stearate, Aspartame, Glycerol, Soya-bean oil and Macrogol 3350.
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.
Nature and composition of immediate packaging
Cardboard box with 1 aluminium foil blister sealed with paper/PET aluminium foil lid stock containing 1, 2 or 4 chewable tablets.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
MARKETING AUTHORISATION NUMBER(S)
EU/2/13/158/001 Bravecto 112.5 mg chewable tablets for very small dogs
EU/2/13/158/004 Bravecto 250 mg chewable tablets for small dogs
EU/2/13/158/007 Bravecto 500 mg chewable tablets for medium-sized dogs
EU/2/13/158/010 Bravecto 1000 mg chewable tablets for large dogs
EU/2/13/158/013 Bravect0 1400 mg chewable tablets for very large dogs
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11 February 2014.
POM-V To be supplied only on veterinary prescription.
MSD Animal Health
Bravecto is in tablet form and allows fuss-free administration for most dogs. The active ingredient, fluralaner, is absorbed into the blood stream and affects parasites after they take a blood meal from the dog; it takes just 8 hours to kill exposed fleas and 12 hours to kill exposed ticks. Fluralaner belongs to a group of ectoparasiticides called the isoxazolines and kills by causing spastic paralysis. A primary target is the GABA receptor which normally prevents repetitive or uncontrolled firing of action potentials (impulses) by allowing entry of negatively charged ions (anions). When fluralaner binds GABA receptor, anion flow is inhibited, so nerve and muscle cells remain excited. Accumulation of positively charged ions (cations) leaves nerve and muscle cells hyperexcited, and induces loss of regulated muscle contraction and death.
For customers wishing to treat their dogs less regularly, Bravecto seems like it would be the ideal choice, as it lasts three times longer than the majority of flea and tick products on the current market. Its systemic, persistent action will ensure that your pet is fully protected but at the same time, the chemical is not a risk to a dog's health. At present, there is little information available but the product promises to be an effective treatment for fleas and ticks and will be a valuable asset when treating dogs with Flea Allergy Dermatitis (FAD). Bravecto will be classified as a POM-V medication and will therefore require a prescription from your veterinary surgeon, which you can send to us at VioVet to supply.
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