Name
ADTAB CHEWABLE TABLETS FOR DOGS
Pharmacotherapeutic Group
Ectoparasiticides for systemic use.
Active Substances
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.
Excipients
Powdered cellulose, lactose monohydrate, silicified microcrystalline cellulose, dried meat flavour, crospovidone, povidone K30, sodium lauryl sulphate, colloidal anhydrous silica, magnesium stearate.
Indications
For the treatment of flea and tick infestations in dogs. This veterinary medicinal product 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 start feeding in order to be exposed to the active substance.
Contraindications/Adverse Effects
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Safety in the Target Species
No adverse reactions were observed following oral administration to puppies aged 8-9 weeks weighing 1.3-3.6 kg, treated with overdoses of 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.
Dosage
For oral use. The veterinary medicinal product should be administered according to the following table to ensure a dose of 20 to 43 mg lotilaner/kg body weight. Dog body weight: 1.3-2.5 kg. Strength and number of tablets to be administered. AdTab 56 mg: 1. Dog body weight: >2.5- 5.5 kg. Strength and number of tablets to be administered. AdTab 112 mg: 1. Dog body weight: >5.5-11.0 kg. Strength and number of tablets to be administered. AdTab 225 mg: 1. Dog body weight: >11.0-22.0 kg. Strength and number of tablets to be administered. AdTab 450 mg: 1. Dog body weight: >22.0-45.0 kg. Strength and number of tablets to be administered. AdTab 900 mg: 1. Dog body weight: >45 kg. Strength and number of tablets to be administered: appropriate combination of tablets. For dogs over 45 kg, use an appropriate combination of the available strengths to achieve the recommended dose of 20-43 mg/kg. Underdosing may result in ineffectiveness and may favour the development of resistance. To ensure correct dosing, body weight should be determined as accurately as possible. AdTab is a palatable flavoured chewable tablet. Administer the chewable tablet with food or after meals. For optimal control of flea and tick infestations, the product should be administered at monthly intervals during the flea and/or tick season, depending on the local epidemiological situation.
Storage
This veterinary medicinal product does not require any special storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Warnings
Parasites need to start feeding on the host to become exposed to lotilaner; therefore the risk of transmission of parasite-borne diseases cannot be completely excluded. The possibility that other animals in the same household may be a source of flea reinfestation should be considered, and these should be treated as necessary with an appropriate product. Fleas at all stages of development can infest the dog's bedding and regular resting areas such as carpets and soft furnishings. In case of massive flea infestation, and at the start of control measures, these areas should be treated with a suitable environmental product and then cleaned regularly. Special precautions for safe use in the target species: all efficacy and safety data were obtained from dogs and puppies aged 8 weeks or older and weighing 1.3 kg or more. In the absence of available data, a veterinarian should be consulted before treating puppies under 8 weeks of age or weighing less than 1.3 kg. Special precautions to be taken by the person administering the veterinary medicinal product to animals: wash hands after handling the product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the doctor. Special precautions for the protection of the environment: not applicable. No adverse reactions were observed following oral administration to puppies aged 8-9 weeks weighing 1.3-3.6 kg, treated with overdoses of 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. Incompatibilities: not applicable.
Withdrawal Periods
Not applicable.
Target Species
Dog.
Interactions
None known. During clinical field studies, no interactions were observed between lotilaner and routinely used veterinary medicinal products.
Diagnosis and Prescription
Veterinary medicinal product not subject to prescription.
Adverse Effects
Target species: Dog. Very rare (<1 animal / 10,000 animals treated, including isolated reports): , anorexia ^1,2, lethargy ^2, ataxia ^3, convulsions ^3, tremor ^3. ^1 Mild and transient. ^2 Usually resolve without treatment. ^3 Transient in most cases. Reporting adverse events is important as it allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to the marketing authorisation holder or to the national competent authority via the national reporting system. See also the "Contact details" section of the package leaflet.
Pregnancy and Lactation
The safety of the veterinary medicinal product during pregnancy, lactation or in breeding dogs has not been established. Pregnancy and lactation: laboratory studies in rats have not produced any evidence 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 treating breeding dogs.
