Flevox Spot-On

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Containing the renowned active ingredient Fipronil, known for its potency and safety, Flevox provides powerful and durable flea and tick protection. Flevox comes in an easy-to-administer, simple pipette. Applied to the skin on the scruff of the neck in dogs and cats, Flevox is regarded as having an ideal balance between safety and effectiveness for the lasting control of feline and canine fleas and ticks. As with all flea treatments, Flevox Spot-on is ideally used regularly to prevent infestations. Once fleas are being seen, it can be too late for proper control, and difficult to clear the reservoir population from the environment. To provide the best control against fleas, VioVet recommends using Flevox on pets and also the household insecticide Indorex on soft furnishings, carpets and floors.

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
Animals should be weighed accurately prior to treatment.
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.

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.
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.

Flevox 50mg Spot-on Solution for cats
Fiprospot 67, 134, 268 and 402 mg spot-on solution for small, medium, large and very large dogs

Flevox 50mg Spot-on Solution for cats

Presentation

Spot-on solution containing 10% w/v fipronil. Each pipette contains 0.5 ml (50 mg fipronil). Also contains butylhydroxyanisole (E320) and butylhydroxytoluene (E321).

Uses

In cats:

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.

Dosage and administration

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.

Contra-indications, warnings, etc

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.

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.

Special precautions for use

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.

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.

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 cats. Use only according to the benefit/risk assessment by the responsible veterinarian.

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.

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.

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.

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.

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.

Legal category

NFA-VPS

Packaging Quantities

Blisters containing 1 pipette of 0.5 ml. Carton containing 36 blisters.

Further information

Nil

Marketing Authorisation Holder (if different from distributor)

Marketing authorisation number

Vm 08007/4124.

GTIN (Global Trade Item No)

Flevox Spot-on Solution for Cats

03605874254237

Fiprospot 67, 134, 268 and 402 mg spot-on solution for small, medium, large and very large dogs

Presentation

Clear, colourless to yellowish solution for topical application to the skin.

Fiprospot 67 mg spot-on solution for small dogs (2 - 10 kg) contains 67 mg fipronil per 0.67 ml pipette.

Fiprospot 134 mg spot-on solution for medium dogs (10 - 20 kg) contains 134 mg fipronil per 1.34 ml pipette.

Fiprospot 268 mg spot-on solution for large dogs (20 - 40 kg) contains 268 mg fipronil per 2.68 ml pipette.

Fiprospot 402 mg spot-on solution for very large dogs (40 - 60 kg) contains 402 mg fipronil per 4.02 ml pipette.

Uses

For the treatment of dogs against flea infestations (Ctenocephalides spp.)

Insecticidal efficacy against new infestation with fleas persists for up to 6 weeks.

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.

Although the product does not consistently show an immediate acaricidal efficacy (several ticks may be present after 48 hours), it has a persistent acaricidal efficacy for up to 4 weeks against Dermacentor variabilis and up to 3 weeks against Rhipicephalus sanguineus.

Dosage and administration

Only by topical application to the skin.

- Fiprospot 67 mg spot-on solution for small dogs (2 - 10 kg): 1 pipette of 0.67 ml is sufficient for the treatment of a dog with a body weight of 2 kg up to 10 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.

- Fiprospot 134 mg spot-on solution for medium dogs (10 - 20 kg): 1 pipette of 1.34 ml is sufficient for the treatment of a dog with a body weight of 10 kg up to 20 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.

- Fiprospot 268 mg spot-on solution for large dogs (20 - 40 kg): 1 pipette of 2.68 ml is sufficient for the treatment of a dog with a body weight of 20 kg up to 40 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.

- Fiprospot 402 mg spot-on solution for very large dogs (40 - 60 kg): 1 pipette of 4.02 ml is sufficient for the treatment of a dog with a body weight of 40 kg up to 60 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.

For dogs over 60 kg: use two 2.68 ml pipettes (Fiprospot for large dogs)

The minimum interval between two treatments should be not less than 4 weeks.

Advice for the safe application:

Disconnect one of the blisters from the blister card. This helps to avoid accidental opening of the adjacent blister package in order to protect the still unopened pipettes from exposure to humidity. Open the blister with scissors. To avoid damaging of the pipette cut along the line marked with the scissors icon. Carefully peal back the foil from the cut off end and withdraw the pipette.

Hold the pipette upright. Tap lightly to ensure the entire liquid contents are 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 or two spots.

Application of the solution near the base of the head 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.

However, should this occur, it will disappear within 24 hours post application.

For the treatment and control of flea allergy it is recommended that allergic patients and all other dogs and cats in the household should be treated at monthly intervals.

Contra-indications, warnings, etc

Do not use on sick (systemic disease, fever, etc.) or convalescent animals.

Do not use on rabbits, as adverse drug reactions and even death could occur.

This veterinary medicinal product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing.

Do not use on animals with hypersensitivity to the active substance or any other excipients.

Animals should be weighed accurately prior to treatment.

In the absence of available data, the veterinary medicinal product should not be used on puppies less than 2 months old and/or weighing less than 2 kg.

Fiprospot 134 mg spot-on solution for medium dogs should not be used on dogs weighing less than 10 kg.

Fiprospot 268 mg spot-on solution for large dogs should not be used on dogs weighing less than 20 kg.

Fiprospot 402 mg spot-on solution for very large dogs should not be used on dogs weighing less than 40 kg.

It is important to make sure that the product is applied to an area where the animal cannot lick it off. Do not allow recently treated animals to lick each other.

Avoid contact with the animal's eyes. Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water.

Do not apply the veterinary medicinal product to wounds or skin lesions.

There may be an attachment of some ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.

Specific studies investigating the safety of the product following repeated administration or at overdosage have not been conducted due to the known safety profile of the active substance and excipients.

Special warnings for each target species

The veterinary medicinal product does not prevent an infestation of the animal by ticks.

Ticks will usually die within 48 hours of infestation, however attached ticks (both live and killed) may be seen at this time. Some of these will have had a blood meal.

Death normally occurs before the ticks are fully engorged so that the risk of transmission of infectious diseases by ticks is minimised, but cannot be completely ruled out. As soon as the ticks are dead they generally fall off the animal.

For the optimal control of flea problems in households with several animals all dogs and cats should be treated with an authorised insecticide.

Fleas from pets often infest animal's baskets, 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.

Shampooing with a medicated shampoo, followed by thorough drying, 1 to 2 hours before treatment application and bathing once weekly over a period of 6 weeks, has been shown not to affect the efficacy of this veterinary medicinal product against fleas. Bathing and intensive wetting of the coat should be avoided for the first 2 days following administration of the veterinary medicinal product.

Dogs should not be allowed to swim in watercourses for 2 days after application

Adverse reactions

If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier substance.

In very rare cases, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs), vomiting or respiratory signs have been observed after use.

Use during pregnancy and lactation

Laboratory studies using fipronil have not shown any teratogenic or embryotoxic effect. No studies have been carried out on pregnant or lactating dogs using this veterinary medicinal product. Therefore its use during pregnancy and lactation should only be after a relevant benefit-risk analysis made by the treating veterinarian.

Overdose

The toxicity of the veterinary medicinal product administered to the skin is very low. The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.

Special precautions to be taken by the person administering the medicinal product to animals

This veterinary medicinal product can cause mucous and eye irritation. Therefore avoid contact of the product with mouth and eyes.

Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water. If the eye irritation persists, seek medical help at once and show the package insert or label.

Avoid contact with the skin. Should the product come into contact with the skin, wash with soap and water. Wash hands after use.

Do not eat, drink or smoke during application.

Animals or operators with known hypersensitivity to fipronil or one of its components should avoid contact with the veterinary medicinal 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 during the early evening. Moreover recently treated animals should not be allowed to sleep with owners, especially children.

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.

Store in original package. Keep out of reach and sight of children. For animal treatment only.

Any unused product or waste materials should be disposed of in accordance with national requirements. Fipronil may be harmful to aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container.

Legal category

NFA-VPS

Packaging Quantities

Packs containing 3 or 6 pipettes.

Further information

Pharmacodynamic properties

Fipronil is an insecticide and acaricide belonging to the group of phenylpyrazole. It acts by inhibiting the GABA complex, binding to the chloride channel thereby blocking pre- and post-synaptic transfer of chloride ions across the membrane. This results in uncontrolled activity of the central nervous system and hence to death in insects and acarids.

Fipronil acts as an insecticide against fleas (Ctenocephalides spp.) and as an acaricide against ticks (Rhipicephalus sanguineus and Dermacentor variabilis).

Fleas are killed within 48 hours. Most ticks are killed within 48 hours. Some ticks may still be present after 48 hours.

Pharmacokinetic particulars

The veterinary medicinal product distributes itself within 48 hours over the entire skin of the animal.

The absorption of fipronil is negligible in dogs following topical application.

The concentration of fipronil on the fur decreases over time.