WARNINGS
Parasites must begin feeding on the host to be exposed to lotilaner; therefore, the risk of transmission of diseases transmitted by parasites cannot be completely excluded. Consideration should be given to the possibility that other animals in the same household may be a source of reinfection from fleas and these should be treated if necessary with an appropriate product. Fleas, at every stage of their development, can infest the dog’s bedding and normal resting areas such as carpets and upholstered 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 regularly cleaned. Special precautions for safe use in target species: all data on efficacy and safety have been obtained from dogs and puppies 8 weeks or older and with a body weight of 1.3 kg or greater. In the absence of available data, a veterinarian should be consulted before treatment in puppies under 8 weeks of age or with a body weight of less than 1.3 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 puppies aged between 8 and 9 weeks with a body weight of 1.3-3.6 kg, treated with overdoses up to 5 times the maximum recommended dose (43 mg, 129 mg, and 215 mg of lotilaner/kg body weight) on eight occasions at monthly intervals. Incompatibility: not applicable.
PHARMACEUTICAL 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 DOGS
DIAGNOSIS AND PRESCRIPTION
Veterinary medicine not subject to prescription.
EXCIPIENTS
Powdered cellulose, monohydrate lactose, microcrystalline cellulose, dried meat flavor, crospovidone, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate.
ADVERSE EFFECTS
Target species: Dog. Very rare (<1 animal / 10,000 treated animals, including isolated reports): Diarrhea ^1,2, vomiting ^1,2, anorexia ^1,2, lethargy ^2, ataxia ^3, seizures ^3.^1 Mild and transient. ^2 Usually resolve without treatment.^3 Are transient in most cases. Reporting of adverse events is important as it allows for continuous monitoring of the safety of a veterinary medicine. Reports should be submitted, preferably, through a veterinarian, to the marketing authorization holder or the national competent authority via the national reporting system. See also the "Contact" section of the package leaflet.
PREGNANCY AND LACTATION
The safety of the veterinary medicine during pregnancy, lactation, or in breeding dogs has not been established. Pregnancy and lactation: laboratory studies in rats did not show the existence of 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 treatment in breeding dogs.
INDICATIONS
For the treatment of flea and tick infestations in dogs. This veterinary medicine provides immediate and persistent flea-killing (Ctenocephalides felis and C. canis) and tick-killing (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus, and Dermacentor reticulatus) activity for 1 month. Fleas and ticks must attach to the host and begin feeding to be exposed to the active ingredient.
INTERACTIONS
None known. During field clinical studies, no interactions between lotilaner and commonly used veterinary medicines were observed.
DOSAGE
For oral use. The veterinary medicine should be administered according to the following list to ensure a dose of lotilaner from 20 to 43 mg/kg body weight. Dog body weight: 1.3-2.5 kg. Dosage and number of tablets to be administered. AdTab 56 mg: 1. Dog body weight: >2.5-5.5 kg. Dosage and number of tablets to be administered. AdTab 112 mg: 1. Dog body weight: >5.5-11.0 kg. Dosage and number of tablets to be administered. AdTab 225 mg: 1. Dog body weight: >11.0-22.0 kg. Dosage and number of tablets to be administered. AdTab 450 mg: 1. Dog body weight: >22.0-45.0 kg. Dosage and number of tablets to be administered. AdTab 900 mg: 1. Dog body weight: >45 kg. Dosage and number of tablets to be administered: appropriate combination of tablets. For dogs weighing over 45 kg, use an appropriate combination of available dosages to achieve the recommended dose of 20-43 mg/kg. Underdosing may cause ineffectiveness and promote the development of resistance. To ensure correct dosing, determine body weight as accurately as possible. AdTab is a palatable chewable tablet. Administer the chewable tablet with food or after meals. For optimal control of flea and tick infestation, the product should be administered at monthly intervals during the flea and/or tick season, based on local epidemiological situations.
ACTIVE INGREDIENTS
Active substance: chewable tablet. AdTab chewable tablets for dogs (1.3-2.5 kg). Lotilaner: 56.25 mg. AdTab chewable tablets for dogs (>2.5-5.5 kg). Lotilaner: 112.5 mg. AdTab chewable tablets for dogs (>5.5-11 kg). Lotilaner: 225 mg. AdTab chewable tablets for dogs (>11-22 kg). Lotilaner: 450 mg. AdTab chewable tablets for dogs (>22-45 kg). Lotilaner: 900 mg.
SAFETY IN TARGET SPECIES
No adverse reactions were observed after oral administration to puppies aged between 8 and 9 weeks with a body weight of 1.3-3.6 kg, treated with overdoses up to 5 times the maximum recommended dose (43 mg, 129 mg, and 215 mg of lotilaner/kg body weight) on eight occasions at monthly intervals.
TARGET SPECIES
Dog.
WITHDRAWAL TIME
Not applicable.
USE/ROUTE OF ADMINISTRATION
For oral use.