Target species
Dogs.
Indications for use, specifying the target species
For dogs with, or at risk from, mixed external and internal parasitic infestations. The veterinary medicinal product is exclusively indicated when use against ticks, fleas or mites and gastrointestinal nematodes is indicated at the same time. The veterinary medicinal product also provides concurrent efficacy for the prevention of heartworm disease, angiostrongylosis and thelaziosis.
Ectoparasites
− For the treatment of tick infestations. The veterinary medicinal product has immediate and persistent tick killing activity for 5 weeks against Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus and for 4 weeks against Dermacentor reticulatus;
− For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks;
− The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
− For the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
− For the treatment of demodicosis (caused by Demodex canis).
Gastrointestinal nematodes
For the treatment of gastrointestinal roundworm and hookworm infections:
− Toxocara canis immature adults (L5) and adults;
− Ancylostoma caninum L4 larvae, immature adults (L5) and adults;
− Toxascaris leonina adults;
− Uncinaria stenocephala adults.
Other nematodes
− For the prevention of heartworm disease (Dirofilaria immitis);
− For the prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) stages of Angiostrongylus vasorum.
− For the prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection).
Contraindications
Do not use in cases of hypersensitivity to the active substances 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 sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
This veterinary medicinal product is not effective against adult D. immitis. However, accidental administration to dogs infected with adult heartworms should not pose safety concerns. Dogs in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms. Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment. Only negative animals should be treated.
Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class. Therefore, the use of this 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.
Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.25 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
The product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-). However, in such sensitive breeds (which may include, but not necessarily limited to, Collies and related breeds), the recommended dose should be strictly observed.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after handling the product.
The accidental ingestion of the product may potentially result in adverse effects, such as transient excitatory neurological signs. To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required. The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Gastrointestinal signs (such as vomiting, diarrhoea)1 Systemic disorders (such as lethargy, anorexia)1 Neurological signs (such as tremor, ataxia, convulsions)2 |
1In most cases these signs are mild and transient.
2In most cases these signs are transient.
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 its local representative or the national competent authority via the national reporting system. See also section “Contact details” of the package leaflet.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in dogs intended for breeding.
Pregnancy and lactation:
The use in these animals is not recommended.
Fertility:
The use in breeding animals is not recommended.
Interaction with other medicinal products and other forms of interaction
None known.
Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein. Therefore, during treatment with the veterinary medicinal product, 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.
Amount(s) to be administered and administration route
Oral use.
Dose
The veterinary medicinal product should be administered at a dose of 1.2–2.4 mg/kg of sarolaner, 0.024–0.048 mg/kg of moxidectin and 5–10 mg/kg of pyrantel in accordance with the following table:
Bodyweight (kg) | Tablet strength 3 mg/0.06 mg/12.5 mg | Tablet strength 6 mg/0.12 mg/25 mg | Tablet strength 12 mg/0.24 mg/50 mg | Tablet strength 24 mg/0.48 mg/100 mg | Tablet strength 48 mg/0.96 mg/200 mg | Tablet strength 72 mg/1.44 mg/300 mg |
1.25 -2.5 | 1 | | | | | |
>2.5 - 5 | | 1 | | | | |
>5 - 10 | | | 1 | | | |
>10 - 20 | | | | 1 | | |
>20 - 40 | | | | | 1 | |
>40 - 60 | | | | | | 1 |
>60 | Appropriate combination of tablets |
To ensure a correct dosage, bodyweight should be determined as accurately as possible.
Method of administration
Tablets can be administered with or without food.
Simparica Trio tablets are palatable and readily consumed by the majority of dogs when offered by the owner. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The tablets should not be divided.
Treatment schedule:
The treatment schedule should be based on veterinary diagnosis, the local epidemiological situation and/or the epidemiological situation of other areas the dog has visited or is going to visit. If based on veterinarian opinion re-administration(s) of the product is required, any subsequent administration(s) must follow the minimum 1-month interval schedule.
The product should only be used in dogs when treatment of ticks / fleas / mites and gastrointestinal nematodes is indicated at the same time. In the absence of the risk of mixed co-infestation, a narrower spectrum parasiticide should be used.
Treatment of flea and tick infestations and gastrointestinal nematodes:
The veterinary medicinal product can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a mono-active flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infections. A single treatment is efficacious for the treatment of gastrointestinal nematodes. After treatment of the nematode infections, further flea and tick treatment should be continued with a mono-active product.
Prevention of heartworm disease and angiostrongylosis:
A single administration also prevents lungworm disease (by reducing the immature adults (L5) of A. vasorum) and heartworm disease (D. immitis) for one month. When the product replaces another lungworm or heartworm preventive product, the first dose of the product should be given within a month of the last dose of the former veterinary medicinal product. In endemic areas, dogs should receive lungworm and/or heartworm preventive treatments at monthly intervals. It is recommended that heartworm prevention treatment should be continued until at least 1 month after the last exposure to mosquitoes.
Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection):
Monthly administration of the product prevents establishment of infection with adult Thelazia callipaeda eyeworm.
Treatment of demodicosis (caused by Demodex canis):
Administration of a single dose once monthly for two consecutive months is efficacious and leads to a marked improvement of clinical signs. Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart. As demodicosis is a multifactorial disease, it is advisable to also treat any contributing, underlying conditions appropriately.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Administration of a single dose at monthly intervals for two consecutive months. Further monthly administrations of the product may be required based on clinical assessment and skin scrapings.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed in 8-weeks old healthy puppies administered with up to 5 times the maximum recommended dose for 7 consecutive monthly administrations.
In a laboratory study, the product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose. After a single administration of 5 times the maximum recommended dose to this sensitive dog breed, transient ataxia and/or muscle fasciculation were observed.
Withdrawal period(s)
Not applicable.