Simparica Dog 5 mg (1.3 - 2.5 kg), 3 tablets is used in the treatment of tick, flea and sarcoptic mange infestation in dogs.


QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:

• Simparica chewable tablets sarolaner 5 (mg)

PHARMACEUTICAL FORM

• Chewable tablets.
• Marbled brown in color, square in shape with rounded edges.
• The number stamped on one side refers to the tablet strength (mg)

CLINICAL PARTICULARS

Target species: Dogs.

Indications for use, specifying target species

• For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate tick-killing activity and is persistent for at least 5 weeks.
• For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea control activity against new infestations for up to at least 5 weeks.
• The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
• For the treatment of sarcoptic mange (caused by S. scabiei).
• Fleas and ticks must attach to the host and begin feeding to be exposed to the active substance.

Contraindications

• Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species

• Parasites must begin feeding to be exposed to sarolaner; therefore the possibility of disease transmission via parasites cannot be excluded.

Special precautions for use in animals

• In the absence of available data, puppies less than 8 weeks of age and/or less than 1.3 kg in weight should not be treated without veterinary advice.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

• Wash hands after handling the product.
• Accidental ingestion of the product may cause adverse effects, such as transient excitatory neurological signs.
• To prevent children from accessing the product, only one tablet should be removed from the blister at a time and only when necessary.
• The blister should be immediately returned to the carton and the carton should be kept out of the sight and reach of children.
• In case of accidental ingestion, seek medical advice immediately and show the package leaflet to the doctor.

Adverse reactions (frequency and severity)

• They don't know each other.

Use during pregnancy, lactation or laying

• The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding animals.
• Laboratory studies in rats and rabbits have produced no evidence of teratogenic effects.
• Use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions with other medicinal products or other forms of interaction

• They don't know each other.

During clinical field trials, no interactions were observed between Simparica chewable tablets for dogs and routine veterinary medicinal products used in dogs.
In laboratory safety studies, no interactions were observed when sarolaner was administered with milbemycin, moxidectin and pyrantel pamoate (efficacy was not investigated in these studies).
Sarolaner is highly bound to plasma proteins and may compete with other highly bound proteins, such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative, warfarin.


METHOD OF ADMINISTRATION

• For oral administration.
• The tablets can be taken with or without food.
• The veterinary medicinal product should be administered at a dose of 2–4 mg/kg body weight, according to the following table:

• Simparica tablets are chewable and palatable, quickly consumed by dogs when offered by the owner.
• If the tablets are not taken voluntarily by dogs, they can be administered with food or directly into the animal's mouth.
• The tablets should not be divided.

Treatment program:

• For optimal control of flea and tick infestations, the veterinary medicinal product should be administered continuously at monthly intervals throughout the season. The need for repeat treatment should be based on the local epidemiological situation.
• For the treatment of scabies (caused by Sarcoptes scabiei var. canis), one dose should be administered at monthly intervals for two consecutive months.

Overdose (symptoms, emergency procedures, antidotes), as appropriate

• In safety studies, the veterinary medicinal product was administered orally to 8-month-old Beagle puppies at doses of 0, 1, 3 and 5 times the maximum exposure dose of 4 mg-kg, at 28-day intervals for 10 doses.
• No adverse effects were reported at the maximum recommended dose (4 mg/kg).
• In the overdose groups, transient and limited to some animals, self-resolving neurological signs were observed: moderate tremors at 3 times the recommended dose and convulsions at 5 times the recommended dose. All dogs recovered without treatment.
• Sarolaner is well tolerated in Collies with multidrug resistance protein 1 deficiency (MDR1 -/-) following a single oral dose at 3 times the recommended dose.
• No treatment-related clinical signs were observed.

Waiting time

• Not applicable.

Pharmacodynamic properties

• Sarolaner is an acaricide and insecticide belonging to the isoxazoline family. The primary target of action of sarolaner in insects and mites is functional blockade by binding to chloride channels (GABA receptors and glutamate receptors). Sarolaner blocks the chloride channels of the GABA and glutamate complex in the central nervous system of insects and mites. The disruption of these receptors by sarolaner prevents the transmission of ions through the chloride channels of GABA and glutamate, thus increasing
• nerve stimulation and death of the target parasite. Sarolaner exhibits a high affinity for blocking insect/mite receptors compared to mammalian receptors. Sarolaner does not interact with known insecticide, nicotinic or GABA binding sites, such as
• neonicotinoids, fiprols, milbemycins, avermectins and cyclodienes. Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as against several tick species such as Dermacentor reticulatus, Dermacentor variabilis, Ixodes hexagonus, Ixodes holocyclus, Ixodes ricinus, Ixodes scapularis, Rhipicephalus sanguineus, Amblyomma americanum, Amblyomma maculatum and mange mites (Sarcoptes scabiei, Demodex canis and Otodectes cynotis).
• For fleas, the onset of efficacy occurs 8 hours after attachment and lasts 28 days after application of the product. For ticks, the onset of efficacy occurs 12 hours after attachment and lasts 28 days after application of the product. Ticks on the animal, existing before administration, are killed within 24 hours of administration.
• The veterinary medicinal product kills hatched fleas on the dog before they lay eggs and thus prevents the contamination of the environment with fleas in areas where dogs have access.

Pharmacokinetic features

• 85%. Sarolaner was dosed proportionally to Beagle dogs from 2–4 mg/kg to 20 mg/kg. The prandial state of the dog did not significantly affect the extent of absorption.
• Sarolaner had a low clearance rate (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg). The half-life was comparable for the two routes of administration, intravenous and oral, at 11 and 12 days, respectively. The degree of plasma protein binding was determined in vitro and calculated to be ≥99.9%.
• A distribution study determined that Sarolaner 14C residues were widely distributed in tissues. Tissue depletion coincided with the plasma half-life.
• The primary route of elimination of the parent molecule is primarily biliary with elimination via the feces.

PHARMACEUTICAL PARTICULARS
List of excipients

• Hypromellose acetate succinate, medium grade
• Lactose monohydrate
• Sodium starch glycolate
• Silica, colloidal anhydrous
• Magnesium stearate
• Corn starch
• Sugar by structure
• Glucose, liquid (81.5% solids)
• Freeze-dried pork liver powder
• Vegetable protein hydrolysate
• Gelatin type A5
• Wheat germ
• Anhydrous calcium hydrogen phosphate

incompatibility

• Not applicable.

Special precautions for storage

• This veterinary medicinal product does not require any special storage conditions.

Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

• Any unused veterinary medicinal product or waste materials derived from the use of such veterinary medicinal products should be disposed of in accordance with local requirements.

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Presentation type: Tablet

Action: Ticks, Fleas

Dog Weight: 1.3-2.5 KG

Pieces Set: 3 pieces

Brand Name: Simparica

Product Code: 9088884225642

Quantity: 3 Tablets