Target species
Cats and ferrets.
Indications for use, specifying the target species
In cats:
To be used against infestations with fleas, alone or in association with ticks and/or biting lice.
- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas 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.
- Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The veterinary medicinal product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data).
- Elimination of biting lice (Felicola subrostratus).
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
In ferrets:
To be used against infestations with fleas, alone or in association with ticks.
- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas.
- Elimination of ticks (Ixodes ricinus). The veterinary medicinal product has a persistent acaricidal efficacy for 4 weeks against ticks (based on experimental data).
Contraindications
In the absence of available data, the veterinary medicinal product should not be used on kittens less than 8 weeks old and/or weighing less than 1 kg. The veterinary medicinal product should not be used on ferrets less than 6 months old. Do not use in rabbits as adverse drug reactions with even mortality, could occur. In absence of studies, the use of the veterinary medicinal product is not recommended in non-target species.
Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of based on its epidemiological features, for each individual animal.
No data on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats and ferrets are available. However, based on information available for dogs shampooed as from 2 days after application of the veterinary medicinal product, it is not recommended to bath animals within 2 days after application of the veterinary medicinal product.
There may be an attachment of single ticks. For this reason a transmission of infectious diseases cannot be completely excluded if conditions
are unfavourable.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.
Other animals living in the same household should also be treated with a suitable product.
Special precautions for use
Special precautions for use in animals
Avoid the contact with the animal’s eyes.
It is important to make sure that the veterinary medicinal product is applied to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
The potential toxicity of the veterinary medicinal product for kittens of less than 8 weeks of age in contact with a treated queen is not documented. Special care should be taken in this case.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product can cause mucous membrane, skin and eye
irritation. Therefore, contact of the veterinary medicinal product with mouth, skin and eyes should be avoided.
People with a known hypersensitivity to fipronil or (S)-methoprene, or alcohol should avoid contact with the veterinary medicinal product. Avoid contents
coming into contact with the fingers. If this occurs, wash hands with soap and water.
After accidental exposure the eye should be rinsed carefully with pure water.
Wash hands after use.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 should be treated during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
Do not smoke, drink or eat during application.
Special precautions for the protection of the environment
See section "Pharmaceutical particulars".
Adverse reactions (frequency and seriousness)
Cats and Ferrets:
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Application site reactions (skin scaling1, hair loss1, itching1, reddening1). Generalised itching or hair loss. Hypersalivation2, vomiting. Increased sensitivity to stimulation3, depression3, other nervous signs3. |
1 Transient
2 If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier.
3 Reversible
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laboratory studies in cats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Pregnancy and lactation:
Cats:
Can be used during pregnancy.
For treatment during the lactating period, see section "Special precautions for use" above.
Ferrets:
The safety of the veterinary medicinal product has not been established in ferrets during pregnancy and lactation. Use only according to the risk-benefit assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Spot-on use.
Underdosing could result in ineffective use and may favour resistance development.
Cats:
The minimum dose is 5 mg/kg bw of fipronil and 6 mg/kg bw of (S)-methoprene, corresponding to one pipette of 0.5 ml per cat.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
Ferrets:
The dose is 50 mg of fipronil and 60 mg of (S)-methoprene per ferret, corresponding to one pipette of 0.5 ml per ferret.
The minimum treatment interval is 4 weeks.
For infestations with fleas and/or ticks, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
Method of administration:
Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette. Snap back the tip. Part the coat on the back of the animal 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not overdose.
The risk of experiencing the adverse events listed above may increase when overdosing (see section "Adverse reactions (frequency and seriousness)" above.
In cats:
No adverse events were observed in target animal safety studies in cats and kittens aged 8 weeks and older and weighing about 1 kg treated once a month at five times the recommended dose for six consecutive months.
Itching may occur following treatment.
Overdose application of the veterinary medicinal product will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.
In ferrets:
In ferrets aged 6 months and older and treated once every 2 weeks for four treatments, at five times the recommended dose, body weight loss was observed in some animals.
Withdrawal period(s)
Not applicable.