AMFLEE 50 MG SPOT-ON SOLUTION FOR CATS

Pharmacotherapeutic group

Ectoparasiticides for topical use.

Active ingredients

1 pipette (0.5 ml) contains: fipronil 50 mg.

Excipients

Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Polysorbate 80, Povidone K25, Dimethyl sulfoxide.

Indications

Treatment and prevention of infestations by fleas (Ctenocephalides spp.) and ticks (Dermacentor reticulatus, Ixodes ricinus) in cats. The product has persistent insecticidal efficacy for up to 4 weeks against fleas (Ctenocephalides spp.) and acaricidal efficacy for up to 4 weeks against Ixodes ricinus and up to 1 week against Dermacentor reticulatus and Rhipicephalus sanguineus. If ticks of the species Rhipicephalus sanguineus are present when the product is applied, not all ticks may be killed within the first 48 hours, but may be killed within one week. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), when this has been previously diagnosed by the veterinarian.

Contraindications and adverse effects

In the absence of available data, do not use the product on kittens under 2 months of age and/or weighing less than 1 kg. Do not use on sick animals (e.g., systemic diseases, fever...) or convalescing animals. Do not use on rabbits, as adverse reactions and even death may occur. Do not use in case of hypersensitivity to the active ingredient, dimethyl sulfoxide, or any of the excipients.

Dosage

For external use only. Administer by topical application to the skin 1 pipette of 0.5 ml per animal. Method of use: Remove the pipette from the triple-layer sachet. Hold the pipette upright, twist and pull off the cap. Invert the cap and replace it on the pipette. Press and twist the cap to break the seal, then remove the cap from the pipette. Part the animal's fur in the area between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and gently squeeze to empty its contents onto the skin, preferably in two spots, one at the base of the head and the other 2-3 cm further back. It is important to ensure that the product is applied to an area that the animal cannot lick and that animals do not lick each other after treatment. The fur must be parted, and the product applied to the skin. Transient coat changes (clumped/greasy fur and/or residue on the fur) may be observed at the application site, which usually disappear within 24 hours. Treatment schedule: For optimal control of flea and/or tick infestations, the treatment schedule can be based on the local epidemiological situation. In the absence of safety studies, the minimum interval between treatments is 4 weeks.

Storage

Store in the original packaging to protect from light and moisture. Do not remove from the sachet until use. Before application, the product must be kept at room temperature (above 14 degrees C) for about an hour.

Warnings

Fleas on animals often infest their bedding, blankets and usual resting areas such as carpets and upholstered furniture which, in case of massive infestations and at the beginning of control measures, must be treated with a suitable insecticide and regularly cleaned with a vacuum cleaner. The product does not prevent ticks from attaching to animals. If the animal has been treated before exposure to ticks, these will be killed within the first 24-48 hours after attachment. Generally, this occurs before the completion of the meal, reducing but not excluding the risk of disease transmission. Once dead, ticks often detach from the animal, but remaining ones can be removed by gently pulling them. No information is available on the effect of baths/shampoos on the product's efficacy in cats. However, based on information available for dogs, weekly one-minute immersions in water reduce the persistence period of insecticidal efficacy against fleas by one week. For optimal control of flea infestations in a multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide. When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications are recommended for allergic patients and other cats in the household. Avoid contact with the animal's eyes. In case of accidental eye contact, wash eyes immediately and thoroughly with water. Do not apply the product to wounds or damaged skin. Animals must be weighed accurately before treatment. Special precautions for the person administering the veterinary medicinal product to animals: This product can cause irritation to mucous membranes and eyes. Therefore, contact between the product and the mouth or eyes must be avoided. In case of accidental eye contact, wash eyes immediately and thoroughly with water. If eye irritation persists, consult a doctor showing them the package leaflet or label. Avoid content coming into contact with fingers. If this happens, wash hands immediately with soap and water. Wash hands after use. Do not smoke, drink or eat during application. Persons with known hypersensitivity to fipronil or dimethyl sulfoxide or any of the excipients should avoid contact with the veterinary medicinal product. Treated animals must not be touched until the application site has dried, and children must not be allowed to play with treated animals until the application site has dried. It is therefore recommended not to treat animals during the day, but in the evening, and not to allow recently treated animals to sleep with owners, especially with children. Keep pipettes in the original container and dispose of used pipettes immediately. Overdose: In target species safety studies, no adverse reactions were observed in cats and kittens 2 months of age or older or weighing approximately 1 kg, treated once a month with 5 times the recommended dose for 3 consecutive months. However, the risk of adverse reactions may increase in case of overdose.

Withdrawal period

Not applicable.

Target species

Cats.

Interactions

None known.

Adverse effects

If the animal licks itself, a brief period of hypersalivation may be observed. Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (scaling, local alopecia, itching, erythema) and general itching or alopecia have been reported after use. Exceptionally, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), and vomiting have been observed after use.

Pregnancy and lactation

Laboratory studies using fipronil have shown no evidence of teratogenic or embryotoxic effects. No studies with this product have been conducted on pregnant or lactating queens. During pregnancy and lactation, use only in accordance with the benefit/risk assessment.