Name
AMFLEE COMBO 50 MG/60 MG SPOT-ON SOLUTION FOR CATS AND FERRETS
Pharmacotherapeutic Category
Ectoparasiticides, insecticides and repellents.
Active Ingredients
Each 0.5 ml pipette contains the active substances: fipronil 50 mg; S-Methoprene 60 mg.
Excipients
Butylated hydroxyanisole (E320) 0.1 mg, butylated hydroxytoluene (E321) 0.05 mg, povidone (K25), polysorbate 80, ethanol 96%, diethylene glycol monoethyl ether.
Indications
Cat. For use against flea infestations, alone or in combination with ticks and/or chewing lice: treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for six weeks after application; treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The veterinary medicinal product has a persistent acaricidal efficacy for up to 2 weeks against ticks; treatment of chewing lice infestations (Felicola subrostratus). The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has previously been diagnosed by a veterinarian. Ferret. For use against flea infestations, alone or in combination with ticks: treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas; treatment of tick infestations (Ixodes ricinus). The veterinary medicinal product has a persistent acaricidal efficacy for 4 weeks against ticks.
Contraindications/Side Effects
In the absence of available data, the veterinary medicinal product should not be used on kittens under 8 weeks of age and/or weighing less than 1 kg. This veterinary medicinal product should not be used on ferrets under 6 months of age. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use on rabbits, due to the risk of adverse reactions and even death. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Safety in the Target Species
The risk of adverse events may increase in case of overdose (see section 3.6). Cat: in target species safety studies, no adverse reactions were observed in cats and kittens aged 8 weeks or older and weighing approximately 1 kg, treated once a month with 5 times the recommended dose for 6 consecutive months. Itching may occur after treatment. Application of an overdose of the veterinary medicinal product may cause a sticky appearance of the coat at the application site. However, should this occur, it will disappear within 24 hours of application. Ferret: in ferrets aged 6 months or older treated once every 2 weeks for four treatments with 5 times the recommended dose, weight loss was observed in some animals.
Dosage
For external use only, spot-on use. One 0.5 ml pipette per cat, corresponding to the minimum recommended dose of 5 mg/kg fipronil and 6 mg/kg S-methoprene, for topical application to the skin. In the absence of safety studies, the minimum treatment interval is 4 weeks. One 0.5 ml pipette per ferret, corresponding to a recommended dose of 50 mg/kg fipronil and 60 mg/kg S-methoprene, for topical application to the skin. The minimum treatment interval is 4 weeks. Method of administration: 1- Remove the pipette from the pouch. Hold the pipette upright, twist and remove the cap. 2- Turn the cap upside down and place it on the other end of the pipette. Press and twist the cap to break the seal, then remove the cap from the pipette. 3- Part the animal's coat on its back at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot.
Storage
Store in the original package in order to protect from light and moisture. This veterinary medicinal product does not require any special temperature storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Warnings
All stages of fleas can infest the cat's basket, 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 insecticide product and vacuumed regularly. To reduce the environmental flea challenge, all animals living in the same household should also be treated with an appropriate veterinary medicinal product for flea control. For the treatment and control of Flea Allergy Dermatitis, it is recommended that allergic patients and all other animals in the household are treated regularly. No information is available on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats and ferrets. However, based on information available for dogs bathed from 2 days after application of the veterinary medicinal product, bathing animals within two days after application is not recommended. Special precautions for safe use in the target species: the attachment of single ticks after treatment cannot be excluded. Therefore the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable. For external use only. Do not administer orally. Avoid contact with the animal's eyes. If the veterinary medicinal product comes into contact with the eyes, rinse immediately with plenty of water. Do not apply the veterinary medicinal product to wounds or skin lesions. It is important to make sure that the veterinary medicinal product is applied directly to an area of dry skin where the animal cannot lick it, and to make sure that animals do not lick each other after treatment. Wait for the application site to dry before allowing the treated dog to come into contact with valuable fabrics or furnishings. Special precautions to be taken by the person administering the veterinary medicinal product to animals: this veterinary medicinal product may cause irritation to mucous membranes, skin and eyes. Therefore contact between the veterinary medicinal product and the mouth, skin and eyes should be avoided. People with known hypersensitivity to fipronil or S-methoprene and/or to any of the ingredients should avoid contact with the veterinary medicinal product. Avoid contact of the contents with the fingers. If this happens, wash hands immediately with soap and water. In case of accidental contact with the eyes, rinse the eyes immediately and thoroughly with clean water. Wash hands after use. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Do not smoke, drink or eat during application. Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day but in the early evening, and that recently treated animals are not allowed to sleep with owners, especially children. Keep the pipettes in the original package until use and dispose of used pipettes immediately. Special precautions for the protection of the environment: not applicable. The risk of adverse events may increase in case of overdose (see section 3.6). Cat: in target species safety studies, no adverse reactions were observed in cats and kittens aged 8 weeks or older and weighing approximately 1 kg, treated once a month with 5 times the recommended dose for 6 consecutive months. Itching may occur after treatment. Application of an overdose of the veterinary medicinal product may cause a sticky appearance of the coat at the application site. However, should this occur, it will disappear within 24 hours of application. Ferret: in ferrets aged 6 months or older treated once every 2 weeks for four treatments with 5 times the recommended dose, weight loss was observed in some animals. Incompatibilities: none known.
Withdrawal Periods
Not applicable.
Target Species
Cat and ferret.
Interactions
None known.
Diagnosis and Prescription
Veterinary medicinal product not subject to prescription.
Side Effects
Cat and ferret ^1. Very rare (< 1 animal / 10 000 animals treated, including isolated reports): application site flaking ^2, application site alopecia ^2, application site itching ^2, application site redness ^2, itching, generalised hair loss, hypersalivation ^3, vomiting, neurological signs ^4, hyperaesthesia ^4, depression ^4. ^1 Frequency not determined (cannot be estimated from the available data) for ferrets. ^2 Transient. ^3 If the animal licks itself, a brief period of hypersalivation may be observed due to the nature of the carrier. ^4 Reversible. 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 its local representative or to the national competent authority via the national reporting system. See the package leaflet for the respective contact details.
Pregnancy and Lactation
Pregnancy. Cat: laboratory studies in cats have not shown any evidence of teratogenic, foetotoxic or maternotoxic effects. The veterinary medicinal product can be used during pregnancy. Ferret: the safety of the veterinary medicinal product has not been established in pregnant ferrets. Use only according to the benefit-risk assessment by the responsible veterinarian. Lactation. Cat: the potential toxicity of the veterinary medicinal product in kittens under 8 weeks of age in contact with treated adults is not documented. Particular caution should be taken in this case. Ferret: the safety of the veterinary medicinal product during lactation has not been established. Use only according to the benefit-risk assessment by the responsible veterinarian.
