Target species
Dogs
Indications for use, specifying the target species
For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product provides immediate and persistent killing activity for 1 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 commence feeding in order to be exposed to the active substance.
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has been previously diagnosed by a veterinary surgeon.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Parasites need to start feeding on the host to become exposed to lotilaner; therefore, the risk of the transmission of parasite borne diseases cannot be completely excluded.
The possibility that other animals in the same household can be a source of re-infection with fleas should be considered, and these should be treated as necessary with an appropriate product.
All stages of fleas 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 beginning of the control measures, these areas should be treated with a suitable environmental product and then vacuumed regularly.
Special precautions for use
i). Special precautions for use in animals All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater. In the absence of available data, a veterinarian should be consulted before treatment in puppies younger than 8 weeks of age or less than 1.3 kg of body weight.
Inform your veterinary surgeon that you are using this product if s/he provides your dog with any other medication.
ii). Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after handling the product.
Special precautions for the protection of the environment:
The active substance is mostly excreted in the faeces (poo) and may be toxic to non-target organisms. In order to avoid contamination of the environment, ensure that dog faeces are bagged up and disposed of safely.
iii) Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
Target species: Dogs
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Diarrhoea1,2, Vomiting1,2; Anorexia1,2, Lethargy2 ; Ataxia3 , Convulsion3 , Tremor3 |
1 Mild and transient
2 Typically resolve without treatment
3 Transient in most cases
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy, lactation or in breeding dogs.
Pregnancy and lactation:
Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established. Consult a veterinarian before treatment during pregnancy and lactation.
Fertility:
Consult a veterinarian before treatment in breeding dogs.
Interaction with other medicinal products and other forms of interaction
None known.
During clinical testing, no interactions between lotilaner and routinely used veterinary medicinal products were observed.
Amount(s) to be administered and administration route
For oral use.
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.
Strength and number of tablets to be administered
Body weight of dog (kg) | Advantage Chewable 56 mg | Advantage Chewable 112 mg | Advantage Chewable 225 mg | Advantage Chewable 450 mg | Advantage Chewable 900 mg |
1.3–2.5 | 1 | | | | |
Greater than 2.5–5.5 | | 1 | | | |
Greater than 5.5–11.0 | | | 1 | | |
Greater than 11.0–22.0 | | | | 1 | |
Greater than 22.0–45.0 | | | | | 1 |
Greater than 45 | | | Appropriate combination of tablets | | |
For dogs of more than 45 kg body weight, use an appropriate combination of available strengths to achieve the recommended dose of 20–43 mg/kg.
Underdosing could result in ineffective use and may favour resistance development.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Advantage Chewable is a palatable chewable flavoured tablet. Administer with food or within 30 minutes of feeding.
For optimal control of flea and tick infestation, the product should be administered at monthly intervals throughout the flea and/or tick seasons, based on local epidemiological situations.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed following 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 bodyweight) on eight occasions at monthly intervals.
Withdrawal period(s)
Not applicable