Dogs.

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, Ixodes hexagonus, and Dermacentor reticulatus,

-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 for up to 12 months. The effect is indirect due to the veterinary medicinal product’s activity against the vector.

Do not use in cases 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 (including Babesia canis canis and D. caninum) cannot be completely excluded. Unnecessary use of antiparasitics, or use deviating from the instructions given, may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features (having regard to the duration of the effect of the product of 12 months), for each individual animal.

The possibility that other animals in the same household can be a source of re-infection with parasites should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product.

Safety of the product has not been assessed in dogs with pre-existing epilepsy. Therefore, use with caution in such dogs based on a benefit/risk assessment by the responsible veterinarian. In the absence of available data, the veterinary medicinal product should not be used on dogs less than 6 months old.

Hypersensitivity reactions to fluralaner or benzyl alcohol in humans have been reported, which can potentially be serious. Also, injection site reactions may occur. Care should be taken to avoid accidental self-injection and dermal exposure when administering this veterinary medicinal product. In case of accidental self-injection with adverse effects, hypersensitivity reactions or injection site reactions, contact a physician and show the label or package leaflet. Wash hands after use.

This veterinary medicinal product is to be administered only by veterinarians or under their close supervision.

Dogs:

1Palpable and/or visual swellings, non-inflammatory, non-painful, self-resolving over time

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.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.

Fluralaner is highly bound to plasma proteins and might compete with other highly bound active substances such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin. Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.

During clinical field testing, no interactions between the veterinary medicinal product and routinely used veterinary medicinal products were observed. .

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:

Calculate the dose accordingly for dogs weighing less than 5 kg or more than 60 kg.

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).

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.

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.

For infestations with fleas and ticks, the need for and frequency of retreatment(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. See section ‘Special warnings’.

Following the subcutaneous administration of 3 and 5 times the recommended dose of 15 mg fluralaner/kg body weight every 4 months for a total of 6 doses (Days 1, 120, 239, 358, 477 and 596) to 6 months old puppies, the only treatment-related finding was limited to injection site swellings that resolved over time. The active substance 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 body weight). Since the peak systemic exposure to fluralaner after subcutaneous administration is not higher compared to oral administration, the subcutaneous injection of the veterinary medicinal product is considered safe in MDR1(-/-) dogs.