Indications for use, specifying the target species
- Treatment and prevention of flea and/or tick infestations.
- Treatment and prevention of flea infestations (Ctenocephalides spp). Immediate insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Prevention of the multiplication of fleas by inhibiting the hatching of flea eggs (ovicidal activity) and the development of flea eggs into adult fleas persists for 6 weeks after application
- Treatment and prevention of tick infestation (Rhipicephalus turanicus). The product has immediate and persistent acaricidal efficacy for 5 weeks after application.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) when previously diagnosed by a veterinary surgeon.
Do not use in rabbits, as adverse reactions, even mortality, could occur.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use on sick (e.g. systemic disease, fever) or convalescent animals.
The attachment of single ticks after treatment cannot be ruled out. Therefore the transmission of infectious disease cannot be completely excluded if conditions are unfavourable.
All stages of fleas can infest the cat’s basket, bedding, and regular resting areas such as carpets and soft furnishings. In cases of massive flea infestation at the beginning of the control measures these areas should be treated with a suitable environmental product. To reduce environmental flea challenge, all animals living in the same household should also be treated with a suitable flea control product.
For the treatment and control of flea allergy dermatitis it is recommended that allergic patients and all other animals in the household should be treated on a regular basis.
No data on the effect of bathing/shampooing on the efficacy of the product in cats is available.
Special precautions for use
Special precautions for use in animals
For external use only. Do not administer orally.
Avoid contact with the eyes of the animal. If the product is in contact with eyes, rinse immediately with plenty of water.
Do not apply the product on wounds or skin lesions.
Wait for the application site to dry before allowing the treated cat to come into contact with valuable fabrics or furnishings. It is important to make sure that the veterinary medicinal product is applied directly onto an area of dry skin where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
In the absence of additional safety studies, do not repeat the treatment at intervals of less than 2 weeks. The safety of the product has not been established in cats younger than 8 weeks of age or weighing less than 0.5kg of body weight (bw).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product can cause mucous membrane, skin and eye irritation.
Therefore, contact of the product with mouth, skin and eyes should be avoided.
In the case of accidental eye contact immediately and thoroughly flush the eyes with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician.
Avoid contents coming into contact with the fingers. If this occurs, wash off immediately with soap and water.
People with known hypersensitivity to fipronil and/or (S)-Methoprene should not treat their animal with this product.
This product may cause neurotoxicity and be harmful if swallowed. Avoid ingestion including hand-to-mouth contact.
Treated animals should not be handled or played with for at least 12-hours after treatment. Animals should be treated in the evening in order to minimise contact with the treated animal. On the day of treatment, treated animals should not be permitted to sleep with their owner, especially children.
Do not eat, drink or smoke while handling the product.
If the product is accidentally swallowed, seek medical advice immediately and show the package leaflet to the physician.
Wash hands thoroughly after use.
Keep stored pipettes in the original packaging until ready to use. In order to prevent children from getting access to used pipettes, dispose of used pipettes immediately in a proper way.
Adverse reactions (frequency and seriousness)
Transient cosmetic effects at the application site such as spiking of the hair, wet appearance, dry residue or slight scaling, were very rarely observed in spontaneous reports. These changes do not affect the safety or the efficacy of the product.
Transient hypersalivation after licking the product was observed very rarely in spontaneous reports mainly due to the excipients of the product.
Use during pregnancy, lactation or lay
Laboratory studies have not produced any evidence of teratogenic or foetotoxic effects with fipronil, although developmental effects (e.g.neurotoxicity) have been shown in rats in one study.
The safety of the veterinary medicinal product has not been established in cats during pregnancy and lactation. Use only according to the benefit/ risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Amounts to be administered and administration route
Spot-on use. Cats 0.5-5kg
One pipette per animal corresponding to the minimal recommended dose of 12 mg/kg bw of fipronil and 6 mg/kg bw of (S)-methoprene.
Treatment can be repeated every 5 weeks or as considered appropriate for the type and level of parasitic exposure. In the absence of appropriate studies, the treatment should not be repeated at intervals of less than 2 weeks.
How to apply:
Disconnect one of the blisters from the card. This helps to avoid accidental opening of the adjacent blisters in order to protect the still unopened pipettes from exposure to humidity. Open the blisters with scissors. To avoid damaging the pipette cut along the line marked with the scissors icon. Carefully peel back the foil from the cut off end and withdraw the pipette.
Hold the pipette upright. Tap lightly to ensure the entire liquid content is within the main body of the pipette. Bend the upper border strip backwards. Then the pipette can be set aside, if necessary. To open the pipette snap off the top of the pipette along the scored line.
Part the coat between 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 content completely and directly onto the skin in one spot.
Application of the solution near the base of the neck minimises the possibility that the animal will lick the solution off. Care should be taken after the application that animals do not mutually lick off the solution.
Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at the treatment spot.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects were observed in a target animal safety study conducted in 8 weeks old kittens (average weight 0.5 kg on the first day of treatment) and treated on 7 consecutive occasions at 2 weeks intervals with up to 5x the recommended dose.