WARNINGS
Parasites must begin to feed on the host to be exposed to lotilaner; therefore, the risk of transmission of parasite-borne diseases cannot be completely excluded. Consideration should be given to the possibility that other animals in the same household may be a source of reinfestation from fleas and these should be treated if necessary with an appropriate product. Fleas, at any stage of their development, can infest the cat’s litter box and normal resting areas such as carpets and upholstery. 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 cleaned regularly. Acceptable levels of efficacy may not be achieved if the veterinary medicine is not administered with food or within 30 minutes of feeding. Due to insufficient data supporting efficacy against ticks in young cats, this product is not recommended for the treatment of ticks in kittens aged 5 months or younger. Special precautions for safe use in target species: safety and efficacy data have been studied in cats aged 8 weeks or older with a body weight of 0.5 kg or more. In the absence of available data, a veterinarian should be consulted before treatment in kittens under 8 weeks of age or weighing less than 0.5 kg. Special precautions to be taken by the person administering the veterinary medicine to animals: wash hands after handling the product. In case of accidental ingestion, seek immediate medical attention showing the package leaflet or label. Special precautions for environmental protection: not applicable. No adverse reactions were observed after oral administration to 8-week-old kittens, weighing 0.5 kg, that had been treated with doses over 5 times the maximum recommended dose (130 mg of lotilaner/kg body weight) on eight occasions at monthly intervals. Incompatibility: not applicable.
PHARMACOTHERAPEUTIC CATEGORY
Ectoparasiticides for systemic use.
STORAGE
This veterinary medicine does not require any special storage conditions. Shelf life of the veterinary medicine packaged for sale: 3 years.
CONTRAINDICATIONS/ADVERSE EFFECTS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
NAME
ADTAB CHEWABLE TABLETS FOR CATS
DIAGNOSIS AND PRESCRIPTION
Veterinary medicine not subject to prescription.
EXCIPIENTS
Powdered yeast (flavor), microcrystalline cellulose, powdered cellulose, lactose monohydrate, povidone K30, crospovidone, sodium lauryl sulfate, vanillin (flavor), anhydrous colloidal silica, magnesium stearate.
ADVERSE EFFECTS
Target species: Cats. Very rare (<1 animal / 10,000 treated animals, including isolated reports): vomiting. ^1 Usually resolves without treatment. Reporting adverse events is important as it allows for continuous monitoring of the safety of a veterinary medicine. Reports should be sent, preferably through a veterinarian, to the marketing authorization holder or the competent national authority via the national reporting system. See also the section "Contact" in the package leaflet.
PREGNANCY AND LACTATION
The safety of the veterinary medicine during pregnancy or lactation has not been established. Pregnancy and lactation: laboratory studies in rats did not show teratogenic effects or adverse effects on the reproductive capacity of males and females. Consult a veterinarian before use during pregnancy and lactation. Fertility: consult a veterinarian before use in breeding cats.
INDICATIONS
For the treatment of flea and tick infestations in cats. This veterinary medicine provides immediate and persistent flea (Ctenocephalides felis and C. canis) and tick (Ixodes ricinus) activity for 1 month. Fleas and ticks must attach to the host and begin to feed to be exposed to the active substance.
INTERACTIONS
None known. During field clinical studies, no interactions between lotilaner and commonly used veterinary medicines were observed.
DOSAGE
For oral use. The flavored veterinary medicine should be administered according to the following list to ensure a single dose of lotilaner from 6 to 24 mg/kg body weight. Cat body weight: 0.5 – 2.0 kg. Dosage and number of tablets to administer: AdTab 12 mg: 1. Cat body weight: >2.0 – 8.0 kg. Dosage and number of tablets to administer: AdTab 48 mg: 1. Cat body weight: >8.0 kg. Dosage and number of tablets to administer: appropriate combination of tablets. In cats weighing over 8 kg, use an appropriate combination of available dosages to achieve the recommended dose of 6-24 mg/kg. Underdosing may result in ineffective use and may promote the development of resistance. To ensure correct dosing, determine the body weight as accurately as possible. Administer the veterinary medicine with food or within 30 minutes of feeding. For optimal control of flea and tick infestations, the veterinary medicine should be administered at monthly intervals and continued during the flea and/or tick season based on local epidemiological situations.
ACTIVE INGREDIENTS
Active substance: chewable tablet. AdTab chewable tablets for cats (0.5-2.0 kg). Lotilaner: 12 mg. AdTab chewable tablets for cats (>2.0-8.0 kg). Lotilaner: 48 mg.
SAFETY IN TARGET SPECIES
No adverse reactions were observed after oral administration to 8-week-old kittens, weighing 0.5 kg, that had been treated with doses over 5 times the maximum recommended dose (130 mg of lotilaner/kg body weight) on eight occasions at monthly intervals.
TARGET SPECIES
Cat.
WITHDRAWAL TIME
Not applicable.
ADMINISTRATION/ROUTE OF ADMINISTRATION
For oral use.