Bravecto
Active substance
ATC code
Species
Dogs.
Indications
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 and Ctenocephalides canis) killing activity for 12 months;
- persistent tick killing activity from 3 days to 12 months after treatment for Ixodes ricinus and Dermacentor reticulatus;
- persistent tick killing activity from 7 days to 12 months after treatment for Ixodes hexagonus;
- persistent tick killing activity from 4 days to 12 months after treatment for Rhipicephalus sanguineus.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus from day 3 after treatment for up to 12 months. The effect is indirect due to the veterinary medicinal product’s activity against the vector.
For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis from day 2 after treatment for up to 12 months. The effect is indirect due to the veterinary medicinal product’s activity against the vector.
Dose to be administered and administration route
Subcutaneous use.
Administer 0.1 ml of reconstituted suspension per kg body weight (equivalent to 15 mg fluralaner per kg body weight) subcutaneously, e.g. between the shoulder blades (dorso-scapular region) of the dog. The dog should be weighed at the time of dosing to calculate an accurate dose.
Underdosing could result in ineffective use and may favour development of resistance.
The following table may be used as a dosage guide:
|
Body weight (kg) |
Volume of the reconstituted suspension (ml) |
|
5 |
0.5 |
|
10 |
1 |
|
15 |
1.5 |
|
20 |
2 |
|
25 |
2.5 |
|
30 |
3 |
|
35 |
3.5 |
|
40 |
4 |
|
45 |
4.5 |
|
50 |
5 |
|
55 |
5.5 |
|
60 |
6 |
Calculate the dose accordingly for dogs weighing less than 5 kg or more than 60 kg.
Reconstitution of the suspension before first use:
Reconstitute 1 vial of powder with 15 ml of solvent. It is recommended to use an 18 G sterile transfer needle and a sterile 20 ml syringe for the reconstitution of the product.
1. Shake the fluralaner powder vial to break up any aggregates prior to reconstitution.
2. Invert the solvent vial at least 3 times until the content is visibly uniform.
3. First inject up to 14 ml of air into the solvent vial, then withdraw 15 ml of the solvent from the vial (image A). There is more solvent supplied in the vial than required for reconstitution. Discard the vial with the rest of the solvent.
4. Insert the 25 G vent needle into the top of the fluralaner powder vial (image B).
5. While rotating the vial horizontally in your hand, slowly transfer the 15 ml of solvent into the fluralaner powder vial to ensure complete wetting of the powder (image C).
 |
||
| A | B | C |
6. Once the solvent has been added, remove the vent needle and the transfer needle from the fluralaner powder vial. Discard the needles.
7. Shake the vial vigorously for at least 30 seconds until a thoroughly mixed suspension is formed. The reconstituted product is an opaque white to pale yellow slightly viscous suspension, practically free of aggregates.
8. The expiry date printed on the label of the glass vial refers to the powder as packaged for sale. After reconstitution, the suspension must be discarded within 3 months from the date of reconstitution. Write the discard date on the label of the glass vial.
Method of administration of the reconstituted suspension to the dog:
1. Determine the dose to be administered based on the dog’s body weight.
2. Use a sterile syringe and a sterile 18 G needle for administration.
3. The fluralaner powder will separate out of suspension upon standing. Before every use, shake the reconstituted vial vigorously for 30 seconds to achieve a uniform suspension.
4. It may be necessary to inject air into the vial prior to dosing.
5. To maintain a uniform suspension and accurate dosing, the dose should be administered within approximately 5 minutes after drawing it into the dosing syringe.
6. Inject the product subcutaneously, e.g. in the dorso-scapular region.
Do not puncture the stopper of the vial containing the reconstituted suspension more than 20 times.
For reconstitution after settling, shake the vial vigorously for at least 30 seconds to achieve a uniform suspension.
Treatment schedule:
For infestations with fleas and ticks, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle. Treatment with this veterinary medicinal product may begin at any time of the year and can continue without interruption.
Adverse reactions
Dogs:
|
Common (1 to 10 animals / 100 animals treated): |
Injection site swelling1 |
|
Uncommon (1 to 10 animals / 1,000 animals treated): |
Decreased appetite Tiredness Hyperaemic mucous membranes |
|
Very rare (<1 animal / 10 000 animals treated, including isolated reports) |
Muscle tremor, ataxia, convulsion |
1Palpable and/or visual signs of non-inflammatory, non-painful swellings were detected from approximately 2 weeks after injection for a period of 1-2 weeks; swellings self-resolved.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section ‘Contact details’ of the package leaflet for contact details.
