Name
AMFLEE 67 MG SPOT-ON SOLUTION FOR SMALL DOGS
Pharmacotherapeutic group
Ectoparasiticides for topical use.
Active substances
1 pipette (0.67 ml) contains: fipronil 67 mg.
Excipients
Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Polysorbate 80, Povidone K25, Dimethyl sulfoxide.
Indications
Treatment of infestations with fleas (Ctenocephalides spp.) and ticks (Dermacentor reticulatus). For the treatment of infestations with Trichodectes canis, the dog biting louse. Most lice are killed within two days. The insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks. The product has a persistent acaricidal efficacy for up to 3 weeks against Ixodes ricinus and up to 4 weeks against Rhipicephalus sanguineus and Dermacentor reticulatus. If ticks of some species (Ixodes ricinus, Rhipicephalus sanguineus) are present when the product is applied, not all ticks may be killed within the first 48 hours. The 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 veterinary surgeon.
Contraindications/Adverse effects
In the absence of available data, do not use in puppies less than 2 months old and/or weighing less than 2 kg. Do not use in sick (e.g. systemic diseases, fever...) or convalescent animals. Do not use in rabbits, as adverse reactions and even death may occur. This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing. Do not use in cases of hypersensitivity to the active substance, to dimethyl sulfoxide or to any of the excipients.
Dosage
For external use only. Administer by topical application to the skin according to body weight as follows: 1 pipette of 0.67 ml per dog weighing over 2 kg and up to 10 kg. Method of administration: Remove the pipette from the triple-layer sachet. Hold the pipette upright, twist and remove the cap. Turn the cap upside down and place it back on the pipette. Push and twist the cap to break the seal, then remove the cap from the pipette. Part the animal's coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze the single-dose pipette several times to empty its contents directly onto the skin in one or two spots. It is important to make sure that the product is applied to an area where the animal cannot lick it off and that animals do not lick each other after treatment. The coat must be parted and the product applied to the skin. Temporary changes to the coat (clumped/greasy hair and/or deposits on the hair) may be seen at the application site. 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 package to protect from light and moisture. Do not remove from the sachet until ready to use. Before application, the product should be kept at room temperature (above 14 degrees C) for about one hour.
Warnings
Bathing/immersion in water within 2 days after application of the product should be avoided. Following weekly immersion in water for one minute, the period of persistent insecticidal efficacy against fleas is 7 weeks. The product does not prevent ticks from attaching to animals. If the animal has been treated prior to exposure to ticks, these will be killed in the first 24-48 hours after attachment. This usually happens before engorgement, reducing but not excluding the risk of disease transmission. Once dead, ticks often drop off the animal, but any remaining ones can be removed with a gentle pull. Fleas on animals often infest the basket, bedding and usual resting areas such as carpets and soft furnishings which, in case of massive infestation and at the start of control measures, should be treated with a suitable insecticide and vacuumed regularly. When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other dogs in the household are recommended. For optimal control of flea infestation in a multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide. Animals should be weighed accurately before treatment. Avoid contact with the animal's eyes. In case of accidental eye contact, immediately rinse the eyes thoroughly with water. It is important to make sure that the product is applied to an area where the animal cannot lick it off and that animals do not lick each other after treatment. Do not apply the product to wounds or damaged skin. Special precautions for the person administering the veterinary medicinal product to animals: this product can cause mucous membrane and eye irritation. Therefore, contact of the product with the mouth or eyes should be avoided. In case of accidental eye contact, immediately rinse the eyes thoroughly with water. If eye irritation persists, seek medical advice and show the package leaflet or the label to the doctor. Do not smoke, drink or eat during application. Avoid the contents coming into contact with the fingers. If this happens, wash hands immediately with soap and water. Wash hands after use. People with known hypersensitivity to fipronil, dimethyl sulfoxide or any of the excipients should avoid contact with the veterinary medicinal product. 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 their owners, especially children. Keep pipettes in the original packaging and dispose of used pipettes immediately. Other precautions: fipronil may be harmful to aquatic organisms. Dogs should not be allowed to swim in watercourses for two days after application. Overdose: in safety studies in the target species, no adverse reactions were observed in 8-week-old puppies, growing dogs and dogs weighing about 2 kg treated once at five times the recommended dose. The risk of adverse reactions (see section 4.6) may, however, increase with overdosing, so animals should always be treated with the pipette of the correct strength for their body weight.
Withdrawal period
Not applicable.
Target species
Dogs.
Interactions
None known.
Adverse effects
If the animal licks the application site, a brief period of hypersalivation may be observed. Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discolouration, local alopecia, itching, erythema) and general itching or alopecia have been reported after use. Hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have exceptionally been observed after use.
Pregnancy and lactation
Laboratory studies using fipronil have not shown any evidence of teratogenic or embryotoxic effects. No studies have been carried out with this product in pregnant or lactating bitches. During pregnancy and lactation, use only according to the benefit/risk assessment.
