Antiparasitario masticable para perros ADTAB de 5.5 kg a 11 kg, 1 ud

Qualitative and quantitative composition

Active substance:

Each chewable tablet contains:

Dogs (1.3–2.5 kg): 56.25 mg Lotilaner

Dogs (>2.5-5.5 kg): 112.5 mg Lotilaner

Dogs (>5.5-11 kg): 225 mg Lotilaner

Dogs (>11-22 kg): 450 mg Lotilaner

Dogs (>22-45 kg): 900 mg Lotilaner

Excipients:

Qualitative composition of excipients and other constituents

Cellulose, powder

Lactose monohydrate

Silified microcrystalline cellulose

Dried meat flavor

Crospovidone

Povidone K30

Sodium lauryl sulfate

Silica, colloidal anhydrous

Magnesium stearate

White to beige round chewable tablets with brown spots.

Target species

Dogs.

Indications for use for each target species

Treatment of flea and tick infestations in dogs.

This veterinary medicinal product provides immediate and persistent action for a 1 month of elimination of fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).

Fleas and ticks must be attached to the host and carry out their food cycle to be exposed to the active ingredient.

Contraindications

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

Special warnings

Parasites must start feeding on the dog to be exposed to lotilaner; For this reason, the risk of contagion of parasitically transmitted diseases cannot be totally excluded.

The possibility that other animals in the same household may be a source of flea reinfection should be taken into account, and these should be treated as necessary with a suitable product.

All phases of fleas can infest dog bedding and usual resting areas such as carpets and furniture. In case of massive flea infestation and at the beginning of control measures, these areas should be treated with a suitable environmental product and then vacuumed regularly.

Special precautions for use

Special precautions for safe use in target species:

All efficacy and safety data have been acquired with puppies and dogs 8 weeks of age or older and weighing 1.3 kg or more. In the absence of available data, the veterinarian should be consulted before treating puppies less than 8 weeks of age or weighing less than 1.3 kg.

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

Wash hands after use of the product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the doctor.

Special precautions for environmental protection:

Not applicable.

Adverse events

Target species: Dogs

Very rare (<1 animal per 10 000 animals treated, including isolated reports)

Mild and transient. Usually resolves without treatment: Diarrhea, Vomiting and Anorexia

Usually resolves without treatment: lethargy

Transient in most cases: Ataxia, Seizures, Tremors

Reporting of adverse events is important. It allows continuous monitoring of the safety of a veterinary medicinal product. Notifications shall preferably be sent through a veterinarian to the marketing authorisation holder or to the national competent authority through the national notification system. See the "Contact details" section of the package leaflet.

Use during pregnancy, lactation or laying

The safety of the veterinary medicinal product has not been demonstrated during pregnancy, lactation or in breeding dogs.

Pregnancy and lactation:

Laboratory studies in rats have not demonstrated teratogenic effects or any adverse effects on the reproductive capacity of males and females. Consult the veterinarian before treatment during pregnancy and lactation.

Fertility:

Consult your veterinarian before treating breeding dogs.

Interaction with other medicinal products and other forms of interaction

None known. During clinical trials, no interactions have been observed between lotilaner and routinely used veterinary medicinal products.

Dosage and routes of administration

Orally.

The veterinary medicinal product should be administered according to the table below to ensure a dose of 20 to 43 mg lotilaner/kg body weight.

Lotilaner Elanco

450 mg

Lotilaner Elanco

900 mg

1,3–2,5

1

>2.5–5.5

1

>5.5-11.0

1

>11.0-22.0

1

>22.0-45.0

1

>45

Appropriate combination of tablets

For dogs weighing more than 45 kg use an appropriate combination of available doses to achieve the recommended dose of 20–43 mg/kg.

Insufficient dosing could result in ineffective use and promote the development of resistance.

To ensure correct dosing, the weight must be determined as accurately as possible.

Lotilaner Elanco is a chewable tablet with a pleasant taste. Administer the chewable tablet(s) once a month during or after a meal.

For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and maintained throughout the flea or tick season depending on local epidemiological situations.

Overdose symptoms (and, where appropriate, emergency procedures and antidotes)

No adverse reactions have been observed during oral administration to puppies aged 8 to 9 weeks weighing 1.3–3.6 kg treated with overdosage up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg body weight) on eight occasions at monthly intervals.

Restrictions and special conditions of use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products, in order to reduce the risk of development of resistance

Not applicable.

Waiting times

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Special precautions for storage

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

Classification of veterinary medicinal products

Medicinal product not subject to veterinary prescription.