AdTab 450 mg chewable tablets for dogs against fleas and ticks (11-22 kg) - 1 tablet
1. NAME OF THE VETERINARY MEDICINAL PRODUCT AdTab 56 mg chewable tablets for dogs (1.3–2.5 kg) AdTab 112 mg chewable tablets for dogs (>2.5–5.5 kg) AdTab 225 mg chewable tablets for dogs (>5.5–11 kg) AdTab 450 mg chewable tablets for dogs (>11–22 kg) AdTab 900 mg chewable tablets for dogs (>22–45 kg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each chewable tablet contains: AdTab chewable tablets lotilaner (mg) for dogs (1.3–2.5 kg) 56.25 for dogs (>2.5–5.5 kg) 112.5 for dogs (>5.5–11 kg) 225 for dogs (>11–22 kg) 450 for dogs (>22–45 kg) 900 Excipients: Qualitative composition of excipients and other constituents Powdered cellulose Lactose monohydrate Silicified microcrystalline cellulose Dried meat flavor Crospovidone Povidone K30 Sodium lauryl sulfate Colloidal anhydrous silicon dioxide Magnesium stearate Round, white-beige chewable tablets with brown dots. 3. CLINICAL INFORMATION 3.1 Target species Dogs. 3.2 Indications for use for each target species For the treatment of flea and tick infestations in dogs. The veterinary medicinal product has immediate and persistent elimination activity for up to one month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus). Fleas and ticks must attach to the host and begin feeding to be exposed to the active substance. 3 3.3 Contraindications Do not use in cases of hypersensitivity to the active substance or any of the excipients. 3.4 Special warnings Parasites must start feeding to be exposed to lotilaner; therefore, the risk of disease transmission via parasites cannot be completely excluded. The possibility that other animals in the household may be a source of flea reinfestation should be considered and should be treated with an appropriate product. Fleas in all stages of development can infest the dog's bedding and usual resting areas such as carpets and soft furnishings. In the event of a heavy flea infestation and at the start of control measures, these areas should be treated with an environmentally appropriate product and then vacuumed regularly. 3.5 Special precautions for use Special precautions for safe use in target species: All safety and efficacy data have been obtained after administration to dogs and puppies at least 8 weeks of age and weighing at least 1.3 kg. In the absence of available data, a veterinarian should be consulted before treatment in puppies less than 8 weeks of age or less than 1.3 kg. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash your hands after handling the product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Special precautions for environmental protection: That's not the case. 3.6 Adverse events Target species: Dogs Very rare (<1 animal / 10,000 animals treated, including isolated reports): Diarrhea1,2, Vomiting1,2; Anorexia1,2, Lethargy2; Ataxia3, Convulsions3, Tremor3 1 Mild and transient 2 It usually resolves without treatment 3 Transient in most cases Reporting of adverse events is important. It allows for the continuous monitoring of the safety of the veterinary medicinal product. Reports should be sent, preferably by the veterinarian, either 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. 3.7 Use during pregnancy, lactation or lay 4 The safety of the veterinary medicinal product has not been established during pregnancy, lactation or in breeding dogs. Gestation and lactation: Laboratory studies in rats have produced no evidence of teratogenic effects or any other adverse effects on male or female reproductive capacity. Consult a veterinarian before treatment, during pregnancy and lactation. Fertility: Consult a veterinarian before treatment in breeding dogs. 3.8 Interaction with other medicinal products and other forms of interaction They don't know each other. During clinical trials, no interactions were observed between lotilanerum and common veterinary medicinal products. 3.9 Routes of administration and doses For oral administration. The veterinary medicinal product should be administered according to the following table to ensure a dose of 20-43 mg lotilaner/kg body weight. Body weight of the dog (kg) The right combination of tablets For dogs weighing more than 45 kg, use an appropriate combination of available strengths to achieve the recommended dose of 20-43 mg/kg. Underdosing may lead to ineffective use and may promote the emergence of resistance. To ensure correct dosage, the body weight of the animals should be determined as accurately as possible. AdTab chewable tablets are palatable and flavored. Take the chewable tablet(s) monthly, with or without food. For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and administration should be continued throughout the flea and/or tick season, depending on local epidemiological situations. 3.10 Symptoms of overdose (and, where appropriate, emergency procedures and antidotes) No adverse reactions were observed after oral administration to puppies aged 8-9 weeks and 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) eight times, at monthly intervals. 3.11 Special restrictions on use and special conditions of use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products, to limit the risk of development of resistance 5 That's not the case. 3.12 Waiting periods That's not the case. 4. PHARMACOLOGICAL INFORMATION 4.1 ATCvet code: QP53BE04 4.2 Pharmacodynamics Lotilaner, a pure enantiomer of the isoxazolines class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis), against the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus, as well as the mites Demodex canis. Lotilaner is a potent inhibitor of gamma-aminobutyric acid (GABA)-gated chloride ion channels, causing rapid death of ticks and fleas. The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin). For fleas, the onset of efficacy occurs within 4 hours of attachment and lasts for one month after administration of the product. Fleas present on the animal before administration are eliminated within 6 hours. For ticks, the onset of efficacy occurs within 48 hours of attachment and lasts for one month after administration of the product. Ticks (I. ricinus) present on the animal before administration are eliminated within 8 hours. The veterinary medicinal product kills existing and newly hatched fleas on animals before they can lay eggs. The product therefore interrupts the flea life cycle and prevents the environment from being contaminated with fleas in areas where dogs have access. 4.3 Pharmacokinetics After oral administration, lotilaner is absorbed immediately, with peak plasma concentrations occurring within 2 hours. Food enhances absorption. The elimination half-life is approximately 4 weeks. This long elimination half-life ensures effective plasma concentrations throughout the dosing interval. The main route of elimination is biliary excretion, with renal excretion being a minor route of elimination (less than 10% of the dose). Lotilaner is metabolized to a small extent to several hydrophilic compounds that can be detected in feces and urine. 5. PHARMACEUTICAL INFORMATION 5.1 Major incompatibilities That's not the case. 5.2 Expiration date Shelf life of the veterinary medicinal product as packaged for sale: 3 years. 5.3 Special precautions for storage This veterinary medicinal product does not require any special storage conditions. 5.4 Nature and composition of primary packaging The tablets are packed in aluminium/aluminium blisters packed in an outer cardboard box. Each strength is available in packs of 1 or 3 tablets. Not all pack sizes may be marketed. 5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products Medicines should not be disposed of via wastewater or household waste. Use systems for the collection of unused veterinary medicinal products or waste materials derived from such products, in accordance with local requirements and national collection systems applicable to the veterinary medicinal product concerned. 6. NAME OF THE MARKETING AUTHORISATION HOLDER Elanco GmbH 7. MARKETING AUTHORISATION NUMBER(S) EU/2/22/288/001–010 8. DATE OF FIRST AUTHORISATION Date of first authorisation: 13/09/2022 9. DATE ON WHICH THE SUMMARY OF PRODUCT CHARACTERISTICS WAS LAST REVISION DD/MM/YYYY 10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS Veterinary medicinal product not available on prescription. Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary). Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information Currently, product safety information is not available. Manufacturer information Currently, manufacturer information is not available. Responsible person information Currently, information about the person responsible is not available. \n Presentation type: Tablets Action: Ticks, Fleas Pieces Set: 1 piece Brand Name: Elanco \n Quantity: 1 Piece