Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species:
Ticks and fleas 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.
Cats in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms. No therapeutic effect against adult Dirofilaria immitis has been established. It is therefore recommended, in accordance with good veterinary practice, that animals of 6 months of age or older and living in areas where a vector exists, should be tested for existing adult heartworm infections before application of the veterinary medicinal product for the prevention of heartworm disease.
For the prevention of heartworm disease in cats that are only temporarily in endemic areas, the product should be applied before the first expected exposure to mosquitoes. The period between treatment and return from the endemic areas should not exceed 60 days.
For the treatment of infections with ear mites (Otodectes cynotis) or the gastrointestinal nematodes T. cati and A. tubaeforme, the need for, and the frequency of, re-treatment as well as the choice of the treatment (monosubstance or combination product) should be evaluated by the prescribing veterinarian.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class under specific circumstances. The use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance. Parasite control is recommended throughout the period of potential infestation risk.
Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
Special precautions for use:
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, treatment of kittens less than 9 weeks of age and cats less than 1.2 kg bodyweight is not recommended.
Treatment of male breeding animals is not recommended.
This product is for topical use and should not be administered orally.
Oral uptake of the product at the maximum recommended dose of 93 mg fluralaner + 4.65 mg moxidectin/kg body weight induced some self-limiting salivation or single incidences of vomiting immediately after administration. It is important to apply the dose as indicated to prevent the animal from licking and ingesting the product.
Do not allow recently treated animals to groom each other.
Do not allow treated animals to come into contact with untreated animals until the application site is dry.
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 obtained with this product at the point of sale 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.
Hypersensitivity reactions to another veterinary medicinal product containing fluralaner and the same excipients as Bravecto Plus 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.
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.
Mild and transient skin reactions at the application site (alopecia, flaking skin and pruritus) were commonly observed in clinical trials.
The following other adverse reactions were uncommonly observed in clinical trials shortly after administration: dyspnoea after licking the application site, hypersalivation, emesis, haematemesis, diarrhoea, lethargy, pyrexia, tachypnoea, mydriasis.
The frequency of adverse reactions is defined using the following convention:
− very common (more than 1 in 10 animals treated displaying adverse reaction(s))
− common (more than 1 but less than 10 animals in 100 animals treated)
− uncommon (more than 1 but less than 10 animals in 1,000 animals treated )
− rare (more than 1 but less than 10 animals in 10,000 animals treated)
− very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy or lactation:
The safety of the veterinary medicinal product has not been established in pregnant or lactating animals and therefore use in such animals is not recommended.
Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein. Therefore, during treatment with Bravecto Plus, other products that can inhibit p-glycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
Amounts to be administered and administration route:
For spot-on use.
Bravecto Plus spot-on solution is available in three pipette sizes.
For the concurrent treatment of infections with ear mites (Otodectes cynotis), a single dose of the product should be applied. Seek further veterinary examination (i.e. otoscopy) 28 days after treatment to determine whether there is re-infestation requiring additional treatment. The choice of the additional treatment (monosubstance or combination product) should be determined by the prescribing veterinarian.
For the concurrent treatment of infections with the gastrointestinal nematodes T. cati and A. tubaeforme, a single dose of the product should be applied. The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian and take into account the local epidemiological situation.
Where necessary, cats can be re-treated at 12-week intervals.
Cats in areas endemic for heartworm, or cats which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to application of Bravecto Plus for the concurrent prevention of infection with adult D. immitis, the advice provided in section 4.4 should be considered.
No adverse reactions were observed following topical administration to kittens aged 9-13 weeks and weighing 0.9-1.9 kg treated with overdoses of up to 5 times the maximum recommended dose (93 mg fluralaner + 4.65 mg moxidectin, 279 mg fluralaner + 13.95 mg moxidectin and 465 mg fluralaner + 23.25 mg moxidectin/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).