Target species
Cat.
Indications for use
The treatment and prevention of flea and tick infestations and/or biting lice.
- Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 5 weeks.
- Treatment of tick infestations (Ixodes spp., Dermacentor spp., Rhipicephalus spp.). The veterinary medicinal product has a persistent acaricidal efficacy for up to 1 month against ticks (based on experimental data).
- Treatment of infestations with biting lice (Felicola subrostratus).
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.
Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use on rabbits, as adverse events and even death could occur. In absence of
studies, the use of the veterinary medicinal product is not recommended in non-target species.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
No data on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats is available. However, based on the 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, transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
In case of infestation, carpets and non-washable furnishings should be treated with an appropriate insecticide household spray to kill eggs and larvae already in the home. Wash all pet bedding at 60°C as fleas often infest the animal's regular resting areas. Vacuum the whole house, including under furniture.
Other pets living in the same household should also be treated with a suitable veterinary medicinal product.
Special precautions for use
Special precautions for safe use in the target species:
For external use only.
Avoid 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 groom each other following treatment until the application site is dry.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Keep 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.
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.
In the event of accidental exposure to the eye, it should be rinsed carefully with water.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
People with a known hypersensitivity (allergy) to insecticides, such as fipronil, or to 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.
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 should not be 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 "Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products".
Other Precautions:
The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.
Adverse events
Cats:
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Application site reactions (skin scaling1, localised hair loss1, itching1, reddening1). Generalised itching or hair loss. Hypersalivation2, vomiting. Hyperaesthesia3,4. Excitation3, unusual behaviour3. Depression. |
1 Transient
2 If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the solvents in the veterinary medicinal product.
3 Reversible
4 Increased sensitivity to light and sound
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
The veterinary medicinal product can be used during pregnancy and lactation.
Laboratory studies using fipronil have not shown any evidence of toxicity to the embryo or
developmental abnormalities in the young.
The safety of the veterinary medicinal product was demonstrated in breeding, pregnant and lactating queens treated with multiple consecutive doses with up to 3 times the maximum recommended dose.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with other flea products which are applied directly on to the animal.
Administration routes and dosage
Spot-on.
Cats should be weighed accurately prior to treatment.
One pipette of 0.5 ml per cat, corresponding to a minimum recommended dose of 5 mg/kg of fipronil, by topical application to the skin.
In the absence of safety studies, 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 upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Break back the snap-off top from the spot-on pipette along the scored line. Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette against the skin and squeeze gently to empty its contents directly onto the skin, preferably at two spots, one at the base of the skull and a second 2-3cms further back.
Care should be taken to avoid excessive wetting of the hair with the veterinary medicinal product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Do not overdose.
The risk of experiencing adverse effects may however increase with overdosing (see section 3.6.).
No undesirable effects 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.
Withdrawal periods
Not applicable.