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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
Active substance:
Each chewable tablet contains:
| Bravecto chewable tablets | Fluralaner (mg) |
| for very small dogs (2-4.5 kg) | 112.5 |
| for small dogs (>4.5-10 kg) | 250 |
| for medium-sized dogs (>10-20 kg) | 500 |
| for large dogs (>20-40 kg) | 1,000 |
| for very large dogs (>40-56 kg) | 1,400 |
For the full list of excipients, see section “Pharmaceutical particulars”.
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.
Target species
Dogs
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).
Contraindications
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
None known.
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 | |
| 2-4.5 | 1 |
|
|
|
|
| >4.5-10 |
| 1 |
|
|
|
| >10-20 |
|
| 1 |
|
|
| >20-40 |
|
|
| 1 |
|
| >40-56 |
|
|
|
| 1 |
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.
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 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.
Withdrawal period
Not applicable.
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
ATCvet code: QP53BX05.
Pharmacodynamic properties
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.
Pharmacokinetic particulars
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.
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.
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
The netherlands
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.
February 2014.
POM-V To be supplied only on veterinary prescription.
MSD Animal Health
Walton Manor
Walton
Milton Keynes
MK7 7AJ
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.
Cats, Dogs
Pharmaceuticals: Ectoparasiticides: For dogs, For cats
Fluralaner
Bravecto Spot-on Solution for Cats Bravecto Spot-on Solution for Dogs
Bravecto Spot-on Solution for Cats and Dogs
Not applicable.
Bravecto Spot-on Solution for Dogs Bravecto Spot-on Solution for Cats
Each ml contains 280 mg fluralaner.
For the full list of excipients, see 'Pharmaceutical particulars' section.
Spot on solution. Clear colourless to yellow solution.
Cats and Dogs.
For the treatment of tick and flea infestations in cats and dogs.
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.
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
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).
Do not use in case 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.
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.
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.
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. This product and the wet skin of a recently treated animal may be slightly irritating to skin and/or eyes. Avoid contact with the skin and/or eye, including hand-to-eye contact. Do not eat, drink or smoke while handling the product. Do not contact, or allow children to contact the application site until it is dry; it is therefore recommended to treat the animal in the evening. On the day of treatment, treated animals should not be permitted to sleep in the same bed as their owner, especially children. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. In case of contact with eyes, immediately rinse thoroughly with water. The product is flammable. Keep away from heat, sparks, open flame or other sources of ignition. The active ingredient in the product is highly lipophilic and binds to skin and may also bind to surfaces after spillage of the product. The following precautions are therefore recommended:
Do not allow treated animals to come into contact with untreated animals until the application site is dry.
Commonly observed adverse reactions in clinical trials were mild and transient skin reactions at the application site (2.2% of treated cats), such as erythema and pruritus or alopecia. 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).
Commonly observed adverse reactions in clinical trials (1.2% of treated dogs) were mild and transient skin reactions such as erythema or alopecia at the application site.
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 10animals in 100 animals) •uncommon (mroe 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, including isolated reports).
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.
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.
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.
For spot-on use.
Bravecto should be administered in accordance with the following table (corresponding to a dose of 40 - 94 mg fluralaner/kg body weight): 
For cats above 12.5 kg body weight, use a combination of two pipettes that most closely matches the body weight.
Immediately before use, open the sachet and remove the pipette. 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.
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.
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.
For optimal control of tick and flea infestation, the product should be administered at intervals of 12 weeks.
Bravecto should be administered in accordance with the following table (corresponding to a dose of 25-56 mg fluralaner/kg body weight) 
For dogs above 56 kg body weight, use a combination of two pipettes that most closely matches the body weight.
Immediately before use, open the sachet and remove the pipette. 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.
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.
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. 
For optimal control of tick and flea infestation, the product should be administered at intervals of 12 weeks.
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.
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.
Not applicable.
Ectoparasiticides for systemic use. ATCvet code: QP53B E02
Fluralaner is an acaricide and insecticide. In cats:
Fluralaner has a high potency against ticks and fleas by exposure via feeding, ie 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), phenylprazoles (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 cats and dogs have access. Newly emerged fleas on a dog or cat are killed before viable eggs are produced. An in vitro study also demonstrated that very low concentrations of fluaralaner 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.
Fluralaner is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 3 and 21 days after administration. The prolonged persistence and slow elimination from plasma (t1/2 = 12 days) and the lack of extensive metabolism provide effective concentrations of flurarlaner for the duration of the inter-dosing interval. Unchanged fluralaner is excreted in faeces and to a very low extent in urine.
Fluralaner is readily absorbed from the topical administration site into the hair, skin and subjacent tissues, from where it is slowly absorbed into the vascular system. A plateau is seen in plasma between 7 and 63 days post administration, after which conentrations decline slowly. The prolonged persistence and slow elimination from plasma (t1/2 = 21 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval. Unchanged flurarlaner is excreted in faeces and to a very low extent in urine.
Dimethylacetamide, Glycofurol, Diethyltoluamide, Acetone
None known.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
This veterinary medicinal product does not require any special temperature storage conditions. The pipettes should be kept in the outer packaging to prevent solvent loss or moisture uptake. The sachets should only be opened immediately prior to use.
Unit dose pipette made of laminated aluminium/polypropylene foil closed with an HDPE cap and packed in a laminated aluminium foil sachet. Each carton box contains 1 or 2 pipettes. Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Intervet International B.V.
EU/2/13/158/018-019 112.5 mg EU/2/13/158/022-023 250 mg EU/2/13/158/026-027 500 mg
EU/2/13/158/016-017 112.5 mg EU/2/13/158/020-021 250 mg EU/2/13/158/024-025 500 mg EU/2/13/158/028-029 1000 mg EU/2/13/158/030-031 1400 mg
11/02/2014
05/2016
For animal treatment only. Keep out of the sight and reach of children.
Legal category: POM-V
Bravecto Spot On Cat 500 mg GTIN:8713184149459
Bravecto Spot On Cat 112.5 mg GTIN:8713184149435
Bravecto Spot On Cat 250 mg GTIN:8713184149442
All prices include VAT where applicable.
Each chewable tablet contains
For the full list of excipients, see section "Pharmaceutical Particulars".
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.
Dogs.
For the treatment of tick and flea infestations in dogs.
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
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.
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.
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.
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.
Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).
Convulsions and lethargy has been reported very rarely in spontaneous (pharmacovigilance) reports.
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).
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.
None known.
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.
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):
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.
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".
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.
Not applicable.
Ectoparasiticides for systemic use.
ATCvet code: QP53BE02.
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.
Pork liver flavour, Sucrose, Maize starch, Sodium lauryl sulfate, Disodium embonate monohydrate, Magnesium stearate, Aspartame, Glycerol, Soya-bean oil and Macrogol 3350.
None known.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
This veterinary medicinal product does not require any special storage conditions.
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.
Intervet International BV, The Netherlands
| EU/2/13/158/001 | Bravecto 112.5 mg 1 x chewable tablets for very small dogs |
|---|---|
| EU/2/13/158/002 | Bravecto 112.5 mg 2 x chewable tablets for very small dogs |
| EU/2/13/158/004 | Bravecto 250 mg 1 x chewable tablets for small dogs |
| EU/2/13/158/005 | Bravecto 250 mg 2 x chewable tablets for small dogs |
| EU/2/13/158/007 | Bravecto 500 mg 1 x chewable tablets for medium-sized dogs |
| EU/2/13/158/008 | Bravecto 500 mg 2 x chewable tablets for medium-sized dogs |
| EU/2/13/158/010 | Bravecto 1000 mg 1 x chewable tablets for large dogs |
| EU/2/13/158/011 | Bravecto 1000 mg 2 x chewable tablets for large dogs |
| EU/2/13/158/013 | Bravecto 1400 mg 1 x chewable tablets for very large dogs |
| EU/2/13/158/014 | Bravecto 1400 mg 2 x chewable tablets for very large dogs |
11 February 2014.
May 2018.
For animal treatment only. Keep out of the sight and reach of children.
Each chewable tablet contains
For the full list of excipients, see section "Pharmaceutical Particulars".
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.
Dogs.
For the treatment of tick and flea infestations in dogs.
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
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.
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.
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.
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.
Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).
Convulsions and lethargy has been reported very rarely in spontaneous (pharmacovigilance) reports.
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).
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.
None known.
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.
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):
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.
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".
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.
Not applicable.
Ectoparasiticides for systemic use.
ATCvet code: QP53BE02.
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.
Pork liver flavour, Sucrose, Maize starch, Sodium lauryl sulfate, Disodium embonate monohydrate, Magnesium stearate, Aspartame, Glycerol, Soya-bean oil and Macrogol 3350.
None known.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
This veterinary medicinal product does not require any special storage conditions.
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.
Intervet International BV, The Netherlands
| EU/2/13/158/001 | Bravecto 112.5 mg 1 x chewable tablets for very small dogs |
|---|---|
| EU/2/13/158/002 | Bravecto 112.5 mg 2 x chewable tablets for very small dogs |
| EU/2/13/158/004 | Bravecto 250 mg 1 x chewable tablets for small dogs |
| EU/2/13/158/005 | Bravecto 250 mg 2 x chewable tablets for small dogs |
| EU/2/13/158/007 | Bravecto 500 mg 1 x chewable tablets for medium-sized dogs |
| EU/2/13/158/008 | Bravecto 500 mg 2 x chewable tablets for medium-sized dogs |
| EU/2/13/158/010 | Bravecto 1000 mg 1 x chewable tablets for large dogs |
| EU/2/13/158/011 | Bravecto 1000 mg 2 x chewable tablets for large dogs |
| EU/2/13/158/013 | Bravecto 1400 mg 1 x chewable tablets for very large dogs |
| EU/2/13/158/014 | Bravecto 1400 mg 2 x chewable tablets for very large dogs |
11 February 2014.
May 2018.
For animal treatment only. Keep out of the sight and reach of children.
Each chewable tablet contains
For the full list of excipients, see section "Pharmaceutical Particulars".
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.
Dogs.
For the treatment of tick and flea infestations in dogs.
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
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.
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.
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.
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.
Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).
Convulsions and lethargy has been reported very rarely in spontaneous (pharmacovigilance) reports.
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).
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.
None known.
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.
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):
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.
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".
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.
Not applicable.
Ectoparasiticides for systemic use.
ATCvet code: QP53BE02.
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.
Pork liver flavour, Sucrose, Maize starch, Sodium lauryl sulfate, Disodium embonate monohydrate, Magnesium stearate, Aspartame, Glycerol, Soya-bean oil and Macrogol 3350.
None known.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
This veterinary medicinal product does not require any special storage conditions.
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.
Intervet International BV, The Netherlands
| EU/2/13/158/001 | Bravecto 112.5 mg 1 x chewable tablets for very small dogs |
|---|---|
| EU/2/13/158/002 | Bravecto 112.5 mg 2 x chewable tablets for very small dogs |
| EU/2/13/158/004 | Bravecto 250 mg 1 x chewable tablets for small dogs |
| EU/2/13/158/005 | Bravecto 250 mg 2 x chewable tablets for small dogs |
| EU/2/13/158/007 | Bravecto 500 mg 1 x chewable tablets for medium-sized dogs |
| EU/2/13/158/008 | Bravecto 500 mg 2 x chewable tablets for medium-sized dogs |
| EU/2/13/158/010 | Bravecto 1000 mg 1 x chewable tablets for large dogs |
| EU/2/13/158/011 | Bravecto 1000 mg 2 x chewable tablets for large dogs |
| EU/2/13/158/013 | Bravecto 1400 mg 1 x chewable tablets for very large dogs |
| EU/2/13/158/014 | Bravecto 1400 mg 2 x chewable tablets for very large dogs |
11 February 2014.
May 2018.
For animal treatment only. Keep out of the sight and reach of children.
Each ml contains 280 mg fluralaner.
Each pipette delivers:
For the full list of excipients, see 'Pharmaceutical particulars' section.
Spot on solution.
Clear colourless to yellow solution.
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:
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):
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.
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.
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)
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.
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.
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.
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
ATCvet code: QP53B E02
Pharmacodynamic properties
Fluralaner is an acaricide and insecticide.
In cats:
In dogs:
In cats and dogs:
Fluralaner has a high potency against ticks and fleas by exposure via feeding, ie 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), phenylprazoles (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 cats and dogs have access.
Newly emerged fleas on a dog or cat are killed before viable eggs are produced. An in vitro study also demonstrated that very low concentrations of fluaralaner 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 particulars
Cats:
Fluralaner is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 3 and 21 days after administration. The prolonged persistence and slow elimination from plasma (t1/2 = 12 days) and the lack of extensive metabolism provide effective concentrations of flurarlaner for the duration of the inter-dosing interval. Unchanged fluralaner is excreted in faeces and to a very low extent in urine.
Dogs:
Fluralaner is readily absorbed from the topical administration site into the hair, skin and subjacent tissues, from where it is slowly absorbed into the vascular system. A plateau is seen in plasma between 7 and 63 days post administration, after which conentrations decline slowly. The prolonged persistence and slow elimination from plasma (t1/2 = 21 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval. Unchanged flurarlaner is excreted in faeces and to a very low extent in urine.
Excipients:
Dimethylacetamide, Glycofurol, Diethyltoluamide, Acetone
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 temperature storage conditions. The pipettes should be kept in the outer packaging to prevent solvent loss or moisture uptake. The sachets should only be opened immediately prior to use.
Immediate packaging:
Unit dose pipette made of laminated aluminium/polypropylene foil closed with an HDPE cap and packed in a laminated aluminium foil sachet. Each carton box contains 1 or 2 pipettes.
Not all pack sizes may be marketed.
Disposal:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Intervet International B.V.
Bravecto Spot-On for Cats:
EU/2/13/158/018-019 112.5 mg
EU/2/13/158/022-023 250 mg
EU/2/13/158/026-027 500 mg
Bravecto Spot-On for Dogs:
EU/2/13/158/016-017 112.5 mg
EU/2/13/158/020-021 250 mg
EU/2/13/158/024-025 500 mg
EU/2/13/158/028-029 1000 mg
EU/2/13/158/030-031 1400 mg
11/02/2014
05/2018
For animal treatment only. Keep out of the sight and reach of children.
Each ml contains 280 mg fluralaner.
Each pipette delivers:
For the full list of excipients, see 'Pharmaceutical particulars' section.
Spot on solution.
Clear colourless to yellow solution.
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:
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):
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.
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.
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)
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.
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.
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.
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
ATCvet code: QP53B E02
Pharmacodynamic properties
Fluralaner is an acaricide and insecticide.
In cats:
In dogs:
In cats and dogs:
Fluralaner has a high potency against ticks and fleas by exposure via feeding, ie 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), phenylprazoles (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 cats and dogs have access.
Newly emerged fleas on a dog or cat are killed before viable eggs are produced. An in vitro study also demonstrated that very low concentrations of fluaralaner 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 particulars
Cats:
Fluralaner is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 3 and 21 days after administration. The prolonged persistence and slow elimination from plasma (t1/2 = 12 days) and the lack of extensive metabolism provide effective concentrations of flurarlaner for the duration of the inter-dosing interval. Unchanged fluralaner is excreted in faeces and to a very low extent in urine.
Dogs:
Fluralaner is readily absorbed from the topical administration site into the hair, skin and subjacent tissues, from where it is slowly absorbed into the vascular system. A plateau is seen in plasma between 7 and 63 days post administration, after which conentrations decline slowly. The prolonged persistence and slow elimination from plasma (t1/2 = 21 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval. Unchanged flurarlaner is excreted in faeces and to a very low extent in urine.
Excipients:
Dimethylacetamide, Glycofurol, Diethyltoluamide, Acetone
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 temperature storage conditions. The pipettes should be kept in the outer packaging to prevent solvent loss or moisture uptake. The sachets should only be opened immediately prior to use.
Immediate packaging:
Unit dose pipette made of laminated aluminium/polypropylene foil closed with an HDPE cap and packed in a laminated aluminium foil sachet. Each carton box contains 1 or 2 pipettes.
Not all pack sizes may be marketed.
Disposal:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Intervet International B.V.
Bravecto Spot-On for Cats:
EU/2/13/158/018-019 112.5 mg
EU/2/13/158/022-023 250 mg
EU/2/13/158/026-027 500 mg
Bravecto Spot-On for Dogs:
EU/2/13/158/016-017 112.5 mg
EU/2/13/158/020-021 250 mg
EU/2/13/158/024-025 500 mg
EU/2/13/158/028-029 1000 mg
EU/2/13/158/030-031 1400 mg
11/02/2014
05/2018
For animal treatment only. Keep out of the sight and reach of children.
Each chewable tablet contains
For the full list of excipients, see section "Pharmaceutical Particulars".
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.
Dogs.
For the treatment of tick and flea infestations in dogs.
This veterinary medicinal product is a systemic insecticide and acaricide that provides:
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.
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.
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.
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.
Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).
Convulsions and lethargy has been reported very rarely in spontaneous (pharmacovigilance) reports.
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).
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.
None known.
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.
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):
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.
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".
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.
Not applicable.
Ectoparasiticides for systemic use.
ATCvet code: QP53BE02.
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.
Pork liver flavour, Sucrose, Maize starch, Sodium lauryl sulfate, Disodium embonate monohydrate, Magnesium stearate, Aspartame, Glycerol, Soya-bean oil and Macrogol 3350.
None known.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
This veterinary medicinal product does not require any special storage conditions.
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.
Intervet International BV, The Netherlands
| EU/2/13/158/001 | Bravecto 112.5 mg 1 x chewable tablets for very small dogs |
|---|---|
| EU/2/13/158/002 | Bravecto 112.5 mg 2 x chewable tablets for very small dogs |
| EU/2/13/158/004 | Bravecto 250 mg 1 x chewable tablets for small dogs |
| EU/2/13/158/005 | Bravecto 250 mg 2 x chewable tablets for small dogs |
| EU/2/13/158/007 | Bravecto 500 mg 1 x chewable tablets for medium-sized dogs |
| EU/2/13/158/008 | Bravecto 500 mg 2 x chewable tablets for medium-sized dogs |
| EU/2/13/158/010 | Bravecto 1000 mg 1 x chewable tablets for large dogs |
| EU/2/13/158/011 | Bravecto 1000 mg 2 x chewable tablets for large dogs |
| EU/2/13/158/013 | Bravecto 1400 mg 1 x chewable tablets for very large dogs |
| EU/2/13/158/014 | Bravecto 1400 mg 2 x chewable tablets for very large dogs |
11 February 2014.
May 2018.
For animal treatment only. Keep out of the sight and reach of children.
Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.
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| Order Total | Weight | Delivery |
| £0-£28.99 | Under 2kg | £2.99 |
| 2kg+ | £4.99 | |
| £29-£38.99 | Under 2kg | Free |
| 2kg+ | £4.99 | |
| £39+ | Under 2kg | Free |
| 2kg+ | Free |
Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.
For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.
We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.
Due to air freight restrictions aerosols cannot ever be sent abroad by Royal Mail. We appreciate your understanding.
Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.
Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.
To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.
*For full details on returns, see our terms and conditions page.
Below are some recent questions we've received regarding Bravecto, including answers from our team.
Archana Mehta Shah
I'm in India n can I place order with prescription from Indian vet?
Hello,
Thank you for your question.
As you are not in the EU we will not require a prescription.
Thank you.
American Canine
We are in the US. So we need a UK prescription?
If we are posting to a US address then we need a US prescription. If we post to the UK then we need a UK prescription.
Debbie
I have a 1 1/2 year old Aussie/Border mix who weighs 60 pounds....is Bravecto safe for collie mixes?
This product has been tested at a three-fold overdose in collies with the known genetic variation and found to be very safe. As long as you give the correct dose it should be perfectly safe for your "collie mix".
Julie cottam
How soon after using stronghold spot on can I safely give my dogs bravecto ?
The active ingredients in these two products are completely different and there is no reason to expect them to interact adversely at all. Theoretically it should be safe to give Bravecto at the same time as Stronghold, but it would be sensible to discuss this with your own vet first.
Will
Will frequent bathing reduce the effectiveness of Bravecto?
I would not expect frequent bating to reduce the effectiveness. It is a systemic product and parasites have to bite the dog to be killed off. This is different from the usual spot-on treatments which coat the surface of the dog and can be washed off.
Cathy D.
I recently acquired a 6 year old rescue German Shepherd. She is on Atopica for anal furunculosis (100mg capsules) and weighs 27kg. Her vaccinations had lapsed so they were given (including the new lepto-4). She had one seizure a few days after the first vacc, which we did not connect, but she had 3 seizures within 24 hours after the second vacc. Previous owner thought she had some seizures but did not connect them with anything. I am about to flea treat her for the first time and was going to use Stronghold which I use for my other GSD, but the leaflet said it can cause seizures so did not want to risk that. I do not know what has been used on her in the past, so was going to use Frontline, then someone mentioned Bravecta. It is just routine treatment, we don't have a particular flea or tick problem. What would you suggest as the safest course of action for her please. Thank you.
It is not possible to predict with certainty when another fit might occur but it is true that some medications might well make another fit more likely. I would recommend Frontline Spot-on for your dog. The active ingredient is virtually not absorbed into the body at all, it just sits on the surface of the skin and coat. It is also very non-toxic to dogs anyway. I think that Frontline would be your safest option rather than a systemic product like Bravecto or Stronghold.
Helen patrick
Is bravecto safe for border collies? Is it palatable and what are the side effects if any?
The safety of Bravecto in collies has been tested (using dogs with the MDR1 deletion mutation) and it has been shown to be safe.
The tablets are palatable and intended to be taken directly. If a dog doesn't wish to take it, it can be disguised in food or administered orally. Tablets should not be split or crushed into food, and it is important to watch that it has been swallowed.
Side effects that may be seen include mild and short-lived gastrointestinal effects such as diarrhoea, vomiting, drooling and lack of appetite.
paul59
I have a small dog and am not sure if she has a tick or not. looks like a small skin tag? I was going to use Bravecta flea and tick chew. If it is a tick will the chew work with existing ticks?
Bravecto should work fine with an existing tick.
If you look very carefully at the base of the "tick", you will see small legs and they will move about if it really is a tick. Most ticks where the observer is not sure if it is a tick or not, turn out not to be if you look carefully. As long as you have averagely normal eyesight, you should be able to tell the difference quite easily. (You can look on Google for images of ticks.)
Judy
Does Bravecto get incorporated into the bitches milk? In other wrods, does it give any direct protection to the pups she is feeding?
Bravecto is safe to use in pregnant and lactating bitches. I am not sure if it transfers directly to the puppies through milk or before birth. However fleas as normally quite well controlled by just treating the bitch anyway so that should be adequately effective. Remember to treat the environment with Indorex or similar if you are aware of a significant flea problem.
Phil Wells
we have just used this product and alot of the ticks have dropped off. but there are some large ones and very small white infant ones still left on the dog. will they drop off on their own or do they have to be removed (larger ones) what about the small white ones?
many thanks
Phil.
The ticks should drop off in time, but it is OK to remove them if you need to. Personally I find that gently rolling large ticks around on the skin will usually work them out, if they are alive or dead. It can take a few minutes with a very persistent large tick, but never leaves the jaws behind.
