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External anti-parasitic topical solution for cats and ferrets.
Contains 18 pipettes.
An external anti-parasitic topical solution for cats and ferrets.
Pharmaceutical form
Solution for spot-on dorsal anointing (Sol.u.d.p.)
Composition per pipette (0.5 ml):
Fipronil 50 mg; (S)-methoprene 60 mg.
Excipients: Butylated hydroxyanisole (E 320) 0.1 mg; butylated hydroxytoluene (E 321) 0.05 mg.
Pharmacotherapeutic group: Topical ectoparasiticides QP53.
Pharmacodynamic properties: Fipronil is an insecticide/acaricide belonging to the phenylpyrazole family. It acts by interacting with ligand-regulated chloride channels, in particular those regulated by the neurotransmitter ?-aminobutyric acid (GABA), blocking the pre- and postsynaptic transfer of chloride ions across the cell membrane. This results in uncontrolled central nervous system activity and death of the insects and mites. Fipronil kills fleas within 24 hours, and ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes scapularis, lxodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava, Haemaphysalis campanulata) and lice within 48 hours after exposure.
(S)-Methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects. This compound mimics the action of juvenile hormone and causes abnormal development and death at different stages of flea development. The ovicidal activity of (S)-methoprene occurs both by direct penetration into the shells of newly laid eggs and by absorption through the cuticle of adult fleas. (S)-methoprene is also effective in preventing the development of flea larvae and pupae, thus preventing contamination of the environment of treated animals by immature flea stages.
Metabolism studies of fipronil have shown that the main metabolite is the sulphone derivative of fipronil.
(S)-methoprene is extensively degraded to carbon dioxide and acetate, which are then incorporated into endogenous materials.
The pharmacokinetic profiles after topical application in cats of fipronil and (S)-methoprene in combination have been studied in comparison to intravenous administrations of fipronil or (S)-methoprene alone. This established absorption and other pharmacokinetic parameters under similar clinical conditions. Topical application, with the additional potential oral exposure from licking, resulted in low systemic absorption of fipronil (18%) with a mean maximum concentration (Cmax) of approximately 100 ng/ml of fipronil and 13 ng/ml of its sulphone derivative in plasma.
Peak plasma concentrations of fipronil are reached rapidly (mean tmax approximately 6 h), and decrease with a mean terminal half-life of approximately 25 h. Fipronil is slightly metabolised to fipronil sulphone in cats.
Plasma concentrations of (S)-methoprene after topical application in cats were below the limit of quantification (20 ng/ml).
(S)-methoprene and fipronil, together with its major metabolite, are well destroyed by the fur of cats one day after application. Concentrations of both fipronil and its sulphone derivative and (S)-methoprene in the coat decrease over time and are detectable for at least 59 days after treatment. Parasites are killed by contact rather than systemic exposure.
No pharmacological interaction between fipronil and (S)-methoprene has been observed.
The pharmacokinetic profile of the veterinary medicinal product has not been investigated in ferrets.
None known.
Cats: Can be used against flea infestations, alone or in association with ticks and/or biting lice.
- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new adult flea infestations persists for 4 weeks. Prevention of flea multiplication by inhibition of the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for six weeks after application.
- Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). Acaricidal efficacy of up to 2 weeks against ticks (based on experimental data).
- Elimination of biting lice (Felicola subrostratus).
Can be used as part of the treatment strategy for the control of flea allergy dermatitis (FAD).
Ferrets: Can be used against flea infestations, alone or in association with ticks.
- Flea (Ctenocephalides spp.) elimination. Insecticidal efficacy against new adult flea infestations persists for 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas.
- Elimination of ticks (Ixodes ricinus). Acaricidal efficacy persists for up to 4 weeks against ticks (based on experimental data).
In the absence of available data, not for use in kittens less than 8 weeks of age and/or weighing less than 1 kg.
Not for use in ferrets less than 6 months of age.
Do not use in sick (systemic disease, fever, etc.) or convalescent animals.
Do not use in rabbits, as adverse reactions, even life-threatening, may occur.
In the absence of studies, use in non-target species is not recommended.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Administer the recommended dose.
Very rare adverse reactions reported include: transient skin reactions at the site of application (scaling, local hair loss, itching, redness) as well as general itching or hair loss. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs) or vomiting have also been observed.
In case of licking, a brief period of excessive salivation may be observed mainly due to the nature of the excipient.
Dorsal spot-on solution.
Cats: One 0.5 ml pipette per cat corresponding to the recommended minimum dose of 5 mg/kg fipronil and 6 mg/kg (S)-methoprene, by topical application to the skin.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
Ferrets: One 0.5 ml pipette per ferret corresponding to a dose of 50 mg fipronil and 60 mg (S)-methoprene per ferret, by topical application to the skin.
The minimum treatment interval is 4 weeks.
Hold the pipette in an upright position. Tap the narrow end of the pipette to ensure that the contents are in the main part of the pipette. Open the tip. Part the animal's hair 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 until the contents are completely emptied directly onto the skin in a single point.
Special precautions for use in animals:
It is important to ensure that the veterinary medicinal product is applied to an area where the animal cannot lick itself and that animals do not lick each other after treatment.
No data are available on the effect of water immersion/soapy baths on the efficacy of the veterinary medicinal product in cats and ferrets. However, based on the information available in shampooed dogs from 2 days after application of the veterinary medicinal product, it is not recommended to bathe animals within 2 days after application of the veterinary medicinal product.
Single tick attachment may occur. For this reason, transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Animal fleas often infest the basket, bedding and resting areas of animals, such as carpets and certain types of furniture which should be treated, in case of massive infestation, with an appropriate insecticide, at the beginning of control measures and regularly vacuumed.
No data are available on the potential toxicity of the veterinary medicinal product to kittens less than 8 weeks old in contact with a treated cat. Particular care should be taken in this case.
Specific precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product may cause eye, skin and mucosal irritation. Therefore, contact of the veterinary medicinal product with the mouth, skin and eyes should be avoided.
Persons with known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product. Avoid contact of the veterinary medicinal product with the fingers. If this occurs, wash hands with soap and water.
After accidental eye exposure, rinse the eye gently with water. Wash hands after use.
Treated animals should not be touched until the application site of the veterinary medicinal product 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 should not be treated during the day, but should be treated in the evening, and that these newly treated animals should not sleep with owners, especially children.
Use during pregnancy and lactation:
Cats: Can be used during gestation.
Ferrets: The safety of the product has not been established in ferrets during pregnancy and lactation. Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian.
Do not store above 30 °C. Store in the original container.
Medicinal product not subject to veterinary prescription.
