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Clinical particulars
Target species
Cats.
Indications for use, specifying the target species
For the treatment of flea and tick infestations on cats.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
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).
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.
Acceptable levels of efficacy may not be achieved if the veterinary medicinal product is not administered with food or within 30 minutes after feeding.
Due to insufficient data to support efficacy against ticks in young cats, this product is not recommended for the treatment of ticks in kittens 5 months of age or younger.
Special precautions for use
i) Special precautions for use in animals
Safety and efficacy data has been studied in cats aged 8 weeks and older with a body weight of 0.5 kg or more. Therefore, use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Wash hands after handling the product.
iii) Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
Target species: Cats
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Vomiting1
1 Typically resolves without treatment
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 or 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 cats has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
During clinical testing, no interactions between Credelio chewable tablets and routinely used veterinary medicinal products were observed.
Amounts to be administered and administration route
For oral use.
The flavoured veterinary medicinal product should be administered in accordance with the following table to ensure a single dose of 6 to 24 mg lotilaner/kg bodyweight.
Body weight of cat (kg)
Strength and number of tablets to be administered
Credelio 12 mg
Credelio 48 mg
0.5-2.0
1
>2.0-8.0
1
>8.0
Appropriate combination of tablets
For cats of more than 8 kg body weight, use an appropriate combination of available strengths to achieve the recommended dose of 6–24 mg/kg.
Administer the veterinary medicinal product with food or within 30 minutes after feeding.
For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed following oral administration to kittens aged 8 weeks, weighing 0.5 kg, which were treated with more than 5 times the maximum recommended dose (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Withdrawal period(s)
Not applicable.