Flevox 50 mg spot-on solution for cats 1 pipette
Treatment of flea and tick infestations in cats
Flevox 50 mg spot-on solution for cats
2. FLEVOX QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 0.5 ml contains:
Fipronil 50 mg
Butylhydroxyanisole (E320) 0.2 mg
Butylhydroxytoluene (E321) 0.1 mg
For a full list of excipients, see section 6.1.
3. FLEVOX PHARMACEUTICAL FORM
Limpid, yellow solution
4. FLEVOX CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
Treatment of flea (Ctenocephalides spp.) and tick (Rhipicephalus sanguineus) infestations.
Insecticidal efficacy against new infestations with adult fleas persists for up to 4 weeks. Newly arriving fleas are killed within 48 hours of landing on the animal. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD) where this has previously been diagnosed by a veterinary surgeon.
The product has a persistent acaricidal efficacy for up to 1 week against ticks (Rhipicephalus sanguineus and Dermacentor reticulatus). If ticks of Dermacentor reticulatus are present when the product is applied, all the ticks may not be killed within the first 48 hours, but they may be killed within a week.
Do not use on kittens less than 8 weeks old and/or weighing less than 1 kg in the absence of available data.
Do not use on sick (systemic diseases, fever…) or convalescent animals.
Do not use in rabbits, as adverse drug reactions and even death could occur.
Do not use in case of hypersensitivity to fipronil or to any of the excipients.
Do not administer orally.
4.4 Special warnings for each target species
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.
Ticks already on the animal prior to treatment may not be killed within the first 48 hours after application of the product, but they may be killed within a week. Removal of ticks already on the animal at the time of application is recommended. The product does not prevent ticks from attaching to the animal. If the animal has been treated prior to exposure to the ticks, most ticks will be killed within 48 hours of infestation. This will usually be prior to engorgement, minimising but not excluding the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may be removed with a gentle pull.
Neither immediate nor persistent efficacy has been demonstrated against Ixodes ricinus.
No data on the effect of bathing/shampooing on the efficacy of the product are available. Therefore, bathing or immersion in water within 2 days of application and more frequent bathing than once a week should be avoided.
For optimum control of flea problems in a multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide.
When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other cats and dogs in the household are recommended.
4.5 Special precautions for use
Special precautions for use in animals
Avoid contact with the animal’s eyes. In case of accidental eye contact, rinse immediately with plenty of water.
Do not apply the product on wounds or damaged skin.
Specific studies investigating the safety of the product following repeated administration have not been conducted due to the known safety profile of the active substance and excipients.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product can cause mucous membrane and eye irritation. Therefore, contact of the product with mouth and eyes should be avoided.
In case of accidental eye contact, rinse immediately with plenty of water. If the irritation persists, seek medical advice and show the container or the package leaflet to the physician.
Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. Wash hands after use.
Do not smoke, drink or eat during application.
Operators with a known hypersensitivity to fipronil or any excipient should avoid contact with the product.
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.
4. 6 Adverse reactions (frequency and seriousness)
If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier.
Among the extremely rare suspected adverse reactions, transient cutaneous reactions at the application site (scaling, local alopecia, pruritus, erythema) and general pruritus or alopecia could occur after use. Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs), vomiting or respiratory signs could be observed after use.
4.7 Use during pregnancy, lactation or lay
Laboratory studies using fipronil have not shown any teratogenic or embryotoxic effect. No study was conducted with this product on pregnant and lactating cats. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
For external use only.
Apply topically to the skin 1 pipette of 0.5 ml per cat.
The minimum treatment interval is 4 weeks.
Method of Administration:
Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze gently to empty its content onto the skin.
It is important to make sure that the 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.
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. However, should this occur, it will generally disappear within 24 hours post application but can persist for up to 2 weeks.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects were observed in target animal safety studies in cats and kittens aged 8 weeks and older and weighing about 1 kg treated once up to five times the recommended dose. The risk of experiencing adverse effects may however increase with overdosing.
4.11 Withdrawal period(s)
5. FLEVOX PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use, including insecticides
ATCvet code: QP53AX15
5.1 Pharmacodynamic properties
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by inhibiting GABA complex, binding to the chloride channel and thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acarids.
Fipronil also inhibits glutamate-activated chloride channels (GloCls) which are only found in invertebrates.
5.2 Pharmacokinetic particulars
After a local application of fipronil to the cat, systemic absorption is negligible. After application, there is a good distribution of the chemical in the hair, presenting a good gradient of concentration between the application zone and the peripheral area.
The principal metabolite is the sulfone derivative of fipronil. However, this may be of limited relevance “in vivo” as fipronil is poorly absorbed in the cat. The concentrations of fipronil on the hair decrease with time.
6. FLEVOX PHARMACEUTICAL PARTICULARS
List of excipients
Diethylene glycol monoethylether
6.3 Shelf life
Shelf life of the veterinary medicinal product as package for sale: 3 years
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
The primary packaging consists of pipettes made of a polyacrylonitrile / polypropylene - cyclic olefin copolymer - polypropylene / polypropylene thermoforming foil sealed with a polyacrilonitrile / aluminium / polyethylene terephthalate lid foil.
Each pipette is included in one individual blister.
Cardboard box containing 1 blister of 1 pipette of 0.5 ml
Cardboard box containing 3 blisters of 1 pipette of 0.5 ml
Cardboard box containing 6 blisters of 1 pipette of 0.5 ml
Cardboard box containing 30 blisters of 1 pipette of 0.5 ml
Cardboard box containing 36 blisters of 1 pipette of 0.5 ml
Cardboard box containing 50 blisters of 1 pipette of 0.5 ml
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste materials should be disposed of in accordance with national requirements.
Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.
7. MARKETING AUTHORISATION HOLDER
Vetoquinol UK Ltd
Buckingham Industrial Estate