Target Species:
Dogs.
Indications for use:
For dogs with, or at risk from, mixed parasitic infestations by ticks or fleas, gastrointestinal nematodes, lungworm and/or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks or fleas and gastrointestinal nematodes is indicated at the same time. The veterinary medicinal product also provides concurrent efficacy for the prevention of heartworm disease and angiostrongylosis.
For the treatment of tick and flea infestations on dogs providing immediate and persistent flea (Ctenocephalides felis and C. canis) and tick (Dermacentor reticulatus, Ixodes hexagonus, I. ricinus, and Rhipicephalus sanguineus) killing activity for 1 month.
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 D. reticulatus for 1 month. 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 C. felis for 1 month. The effect is indirect due to the veterinary medicinal product’s activity against the vector.
Treatment of infections with gastrointestinal nematodes of the following species: roundworms (adult stages of Toxocara canis, and adult stages of Toxascaris leonina) and hookworms (L4, immature adult (L5) and adult stages of Ancylostoma caninum and adult stages of Uncinaria stenocephala).
Prevention of heartworm disease (caused by Dirofilaria immitis).
Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum).
Contraindications:
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species:
Special precautions for safe use in the target species:
Use with caution in dogs with pre-existing epilepsy and in dogs with a history of neurological disorders.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.27 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
In (MDR1-/-) dogs, safety of the veterinary medicinal product has only been investigated after single dosing in a laboratory study. At a single observation timepoint, depression was observed in one animal dosed with the maximum recommended treatment dose, and, in a dose-related manner, in more animals at overdoses. The recommended dose should be strictly observed in MDR1 mutant (-/-) dogs with a non-functional P-glycoprotein, which may include, but not necessarily limited to, Collies and related breeds. Please see also ‘overdose’ section (and where applicable, emergency procedures and antidotes).
The veterinary medicinal product should not be administered at intervals shorter than 1 month as the safety at shorter intervals has not been tested.
Special precautions for use:
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.
Dogs in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms. No therapeutic effect against adult D. immitis has been established. It is therefore recommended, in accordance with good veterinary practice, that all animals 6 months of age or more, living in, or have travelled to, areas where a vector exists, should be tested for existing adult heartworm infections before beginning preventive use with the veterinary medicinal product.
For the treatment of infections with gastrointestinal nematodes, 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.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infections based on epidemiological features, for each individual animal.
In the absence of risk of co-infection with ecto- and endoparasites, a narrow spectrum product should be used.
The possibility that other animals in the same household can be a source of re-infection with ticks, fleas or gastrointestinal nematodes should be considered, and these should be treated as necessary with an appropriate product.
Special precautions for the protection of the environment:
Not applicable.
User warnings:
People with known hypersensitivity to any of the active substances and/or excipients should avoid contact with the veterinary medicinal product.
This veterinary medicinal product is harmful after ingestion. Keep in the original packaging until use, in order to prevent children from getting direct access to the veterinary medicinal product. In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
Do not eat, drink or smoke while handling the veterinary medicinal product.
This veterinary medicinal product may irritate the eyes. Avoid contact with eyes. In case of contact, rinse immediately with plenty of water.
This veterinary medicinal product may irritate the skin or may cause skin sensitization. Wash hands thoroughly with soap and water immediately after use of the veterinary medicinal product.
Adverse Reactions:
Dogs:
Common (1 to 10 animals / 100 animals treated): | Digestive tract disorders (e.g. diarrhoea, emesis)1 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Lethargy2, Hypersalivation1, Decreased appetite |
Very rare (<1 animal / 10,000 animals treated, including isolated reports) | Muscle tremors, ataxia, convulsions3 |
1 Mild and usually resolves within 1 day
2 Mild and usually resolves within 2 days
3 May be serious
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 the package leaflet for respective contact details.
Use during pregnancy or lactation:
The safety of the veterinary medicinal product has not been established during pregnancy, lactation, or in dogs intended for breeding. Laboratory studies with moxidectin in rats and mice have shown evidence of fetotoxic and teratogenic effects.
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
Fertility:
The use is not recommended in breeding animals.
Interactions:
Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein. Therefore, during treatment with the veterinary medicinal product, other products that are substrates or inhibitors of p-glycoprotein (e.g., cyclosporine, digoxin, doxorubicin, ketoconazole, spinosad) should only be used concomitantly according to the benefit/risk assessment of the responsible veterinarian.
During clinical field testing, no interactions between the veterinary medicinal product and routinely used veterinary medicinal products were observed.
Amounts to be administered and administration route:
For oral use.
Dose:
The veterinary medicinal product should be administered orally at a dose of 10-20 mg/kg of fluralaner, 0.025-0.05 mg/kg of moxidectin and 5-10 mg/kg of pyrantel, e.g., as shown in the following table:
The chewable tablet should not be broken or divided.
For dogs above 60 kg, appropriate combinations of chewable tablets should be used.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Underdosing could result in ineffective use and may favour resistance development.
Method of administration:
Administer the veterinary medicinal product at or around the time of feeding.
The veterinary medicinal product is a flavoured chewable tablet. Tablets can be offered to the dog, given with food or placed directly into the mouth. The dog should be observed during administration to confirm that the full tablet is swallowed.
Treatment schedule:
For infestations with ticks, fleas, gastrointestinal nematodes, heartworm and lungworm, the need for and frequency of re-treatments should be based on veterinary advice and should take into account the local epidemiological situation and the animal’s lifestyle.
Ticks and fleas:
For optimal treatment and control of flea and tick infestations, the veterinary medicinal product should be administered at intervals of 1 month.
Gastrointestinal nematodes:
For the concurrent treatment of infections with gastrointestinal nematodes, a single dose of the product should be administered. When necessary, dogs can be re-treated at 1-month intervals.
Heartworm:
The veterinary medicinal product kills Dirofilaria immitis larvae up to one month after their transmission. Therefore, the veterinary medicinal product should be administered at regular monthly intervals during the time of the year when vectors (mosquitoes) are present. Administration should start in the month after the first expected exposure to the vectors and should continue until 1-month after the last exposure to the vectors. Dogs in areas endemic for heartworm, or dogs which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to administration of the veterinary medicinal product for the concurrent prevention of infection with adult D. immitis, the advice provided in ‘Special warnings’ section should be considered. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former medication.
Lungworm:
In endemic areas, monthly administration of the veterinary medicinal product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs.
It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails. Seek veterinary advice regarding information on the optimal time to start treatment with this veterinary medicinal product.
Overdose:
No adverse reactions were observed in 8-weeks old healthy puppies administered up to 5 times the maximum recommended dose for 7 consecutive monthly administrations.
In a laboratory study, in which the veterinary medicinal product was administered once at 3 and 5 times the maximum recommended dose to dogs with a deficient multidrug-resistance protein 1 (MDR1-/-), within 24 hours, dose related neurological signs (mainly depression and emesis), were observed in all treatment groups. After administration of 5 times the maximum recommended dose, isolated incidences of muscle fasciculations were observed in individual animals.
Withdrawal periods:
Not applicable.