Flevox 67mg, 34mg, 268mg and 402mg Spot-on Solution for Dogs

Uses
In dogs:
Treatment of flea (Ctenocephalides spp.) and biting/chewing lice (Trichodectes canis) infestations in dogs.
Insecticidal efficacy against new infestations with adult fleas persists for up to 8 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 the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon.
The product has not demonstrated an immediate acaricidal effect against ticks but has demonstrated persistent acaricidal efficacy for up to 4 weeks against Rhipicephalus sanguineus and Dermacentor reticulatus and up to 3 weeks against Ixodes Ricinus. If ticks of these species 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.
Dosage and administration
For external use only. Spot-on use. Animals should be weighed accurately prior to treatment. Apply topically.
1 pipette of 0.67 ml per dog weighing over 2 kg and up to 10 kg bodyweight.
1 pipette of 1.34 ml per dog weighing over 10 kg and up to 20 kg bodyweight
1 pipette of 2.68 ml per dog weighing over 20 kg and up to 40 kg bodyweight
1 pipette of 4.02 ml per dog weighing over 40 kg and up to 60 kg bodyweight
For dogs over 60 kg use two pipettes of 2.68 ml
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 contents 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.
Contra-indications, warnings, etc
Do not use on puppies less than 8 weeks old and/or weighing less than 2 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.
This product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing.
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.
No data on the effect of bathing/shampooing on the efficacy of the product are available. Therefore, bathing/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.
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.
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.
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.
Other precautions
Fipronil may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application.
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 (skin discoloration, 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.
Use during pregnancy or lactation
Laboratory studies using fipronil have not shown any teratogenic or embryotoxic effect. No study was conducted with this product on pregnant and lactating dogs. Use only according to the benefit/risk assessment by the responsible veterinarian.
Symptoms, emergency procedures, antidotes), if necessary
No adverse effects were observed in target animal safety studies in dogs and puppies aged 8 weeks and older and weighing about 2 kg treated once up to five times the recommended dose. The risk of experiencing adverse effects may however increase with overdosing, so animals should always be treated with the correct pipette size according to bodyweight.
User warnings
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.
People 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.
Keep pipettes in the original packaging and dispose of used pipettes immediately.
Pharmaceutical precautions
This veterinary medicinal product does not require any special storage conditions.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.
Legal category
Legal category:NFA-VPS
Packaging quantities
Blister containing 1 pipette of 0.67 ml (small dogs), 1.34 ml (medium dogs), 2.68 ml (large dogs) or 4.02 ml (very large dogs). Carton containing 36 blisters.