Name
FRONTLINE COMBO SPOT-ON CATS
Pharmacotherapeutic Category
Ectoparasiticides for topical use, including insecticides.
Active Ingredients
Each 0.5 ml pipette contains: fipronil 50.00 mg, (S)-methoprene 60.00 mg, butylhydroxyanisole (E320) 0.10 mg, butylhydroxytoluene (E321) 0.05 mg. For the full list of excipients, see section 6.1.
Excipients
Butylhydroxyanisole (E320), butylhydroxytoluene (E321), ethanol, polysorbate 80 (E433), povidone, diethylene glycol monoethyl ether.
Indications
In cats: for use against flea infestations, alone or in association with ticks and chewing lice. Kills fleas (Ctenocephalides spp.). Insecticidal activity against new infestations with adult fleas persists for 4 weeks. Prevents the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), pupae and larvae (larvicidal activity) originating from eggs laid by adult fleas, for 6 weeks after application. Kills ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has persistent activity against ticks for up to 2 weeks (based on experimental data). Kills chewing lice (Felicola subrostratus). Frontline Combo Spot-on Cats can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). In ferrets: for use against flea infestations, alone or in association with ticks. Kills fleas (Ctenocephalides spp.). Insecticidal activity against new infestations with adult fleas persists for 4 weeks. Prevents the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), pupae and larvae (larvicidal activity) originating from eggs laid by adult fleas. Kills ticks (Ixodes ricinus). The product has persistent acaricidal activity against ticks for 4 weeks (based on experimental data).
Contraindications/Undesirable Effects
In the absence of data, do not use the product on kittens less than 8 weeks old and/or weighing less than 1 kg. Do not use the product on ferrets less than 6 months old. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use on rabbits, as adverse reactions, potentially fatal, could occur. In the absence of studies, it is recommended not to use the product on species other than the target species. 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 side effects (see section 4.6) may increase in case of overdose. In cats: in safety studies, no side effects were observed in cats and kittens aged 8 weeks and over, weighing approximately 1 kg, treated once a month at five times the recommended dose for six consecutive months. Itching may occur after treatment. Applying a higher dose than recommended causes a wet, sticky appearance of the coat at the application site. In any case, should this occur, it will disappear within 24 hours of application. In ferrets: in ferrets aged 6 months and over treated every 2 weeks four times at five times the recommended dose, a decrease in body weight was observed in some animals.
Dosage
For external use only. Spot-on application. One 0.5 ml pipette per cat, corresponding to the minimum recommended dose of 5 mg/kg of fipronil and 6 mg/kg of (S)-methoprene, by topical application to the skin. In the absence of safety data, the minimum treatment interval should be 4 weeks. One 0.5 ml pipette per ferret, corresponding to 50 mg of fipronil and 60 mg of (S)-methoprene, by topical application to the skin. The minimum treatment interval should be 4 weeks. Method of administration: hold the pipette upright and tap the narrow part of the pipette gently so that the liquid remains in the wide part of the pipette. Snap off the pre-cut tip. Part the hair at the base of the neck, on the animal's back between the shoulder blades, until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette several times until it is completely empty, applying the product at one spot directly onto the skin.
Storage
Store below 30 degrees C. Store in the original packaging. Shelf life of the veterinary medicinal product as packaged for sale: 36 months.
Warnings
Avoid contact with the animal's eyes. Other animals living in the same household should also be treated with a suitable product. Special precautions for use in animals: it is important to apply the product to an area where the animal cannot lick it off and to make sure that animals do not lick each other after treatment. For cats and ferrets, no information is available on how bathing or immersion in water may affect the product's activity. However, based on data obtained from dogs washed from 2 days after application, it is recommended to avoid bathing for 2 days after application. Individual ticks may attach to the cat. For this reason, under unfavourable conditions the transmission of infectious diseases cannot be completely excluded. Fleas on animals often infest the animal's basket, bedding and the areas where the animal lives, especially carpets, curtains and soft furnishings; in case of massive infestations and at the start of antiparasitic treatment, these should be treated with a suitable insecticide and vacuumed regularly. The potential toxicity of Frontline Combo Spot-On Cats in kittens under 8 weeks of age in contact with a treated mother has not been documented. Particular care is therefore advised in this case. Special precautions to be taken by the person administering the veterinary medicinal product to animals: the product may cause irritation to mucous membranes, skin and eyes. Avoid contact with the mouth, skin and eyes. People with known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contact of the contents with the hands. If this occurs, wash hands with soap and water. In case of accidental contact with the eyes, rinse thoroughly with water. Wash hands after use. Do not handle treated animals or allow children to play with them until the application site is dry. It is therefore recommended not to treat animals during the day but in the evening, and not to let recently treated animals sleep with their owners, especially children. Do not smoke, drink or eat during application. The risk of side effects (see section 4.6) may increase in case of overdose. In cats: in safety studies, no side effects were observed in cats and kittens aged 8 weeks and over, weighing approximately 1 kg, treated once a month at five times the recommended dose for six consecutive months. Itching may occur after treatment. Applying a higher dose than recommended causes a wet, sticky appearance of the coat at the application site. In any case, should this occur, it will disappear within 24 hours of application. In ferrets: in ferrets aged 6 months and over treated every 2 weeks four times at five times the recommended dose, a decrease in body weight was observed in some animals. Incompatibilities: none known.
Withdrawal Period
Not applicable.
Target Species
Cats and ferrets
Interactions
None known.
Supply and Prescription
Sale is not restricted exclusively to pharmacies and does not require a veterinary prescription.
Undesirable Effects
Do not exceed the recommended dose. Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (scaling, local hair loss, itching, redness) and generalised itching or hair loss after application have been reported. Hypersalivation, reversible neurological symptoms (increased sensitivity to stimulation, depression, other nervous signs) or vomiting have also been observed. If animals lick the application site, transient hypersalivation may be observed, mainly due to the excipients of the product. The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 treated animals showing adverse reactions); common (more than 1 but less than 10 animals in 100 treated animals); uncommon (more than 1 but less than 10 animals in 1,000 treated animals); rare (more than 1 but less than 10 animals in 10,000 treated animals); very rare (less than 1 animal in 10,000 treated animals, including isolated reports).
Pregnancy and Lactation
In cats: the product can be used during pregnancy. For treatment during lactation, see section 4.5. In ferrets: laboratory studies in cats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product during pregnancy and lactation has not been established in ferrets. Use only according to the benefit/risk assessment by the responsible veterinarian.
