Fiprocat 50 mg spot-on solution for cats

Official information

1. Name of the veterinary medicinal product

FIPROCAT 50 MG SPOT-ON SOLUTION FOR CATS

2. Qualitative and quantitative composition

A 0.5 mL pipette contains:
Active substance(s):
Fipronil ...................................................... 50.00 mg
Excipient(s):
Butylhydroxyanisole (E 320) .......................... 0.10 mg
Butylhydroxytoluene (E 321) .......................... 0.05 mg

For a full list of excipients, see "List of excipients".

3. Pharmaceutical form

Spot-on solution.
Clear, colorless to yellowish solution.

4. Clinical information

4.1 Target species
Cats.

4.2 Indications for use, specifying target species
In cats:
- Treatment of flea infestations(Ctenocephalides spp.).

Insecticidal efficacy prevents further flea infestation for 4 weeks.
The drug can be integrated into a treatment program for Flea Allergy Dermatitis (FAD), when this diagnosis has been made by a veterinarian.
Although immediate acaricidal efficacy has not been demonstrated for this product, persistent acaricidal activity for up to a week has been demonstrated against Ixodes ricinus ticks.
If Ixodes ricinus ticks are already present when the drug is applied, not all ticks may be killed within the first 48 hours, but they may be killed within a week.

4.3. Contraindications
Do not use on kittens under 8 weeks of age and/or weighing less than 1 kg, in the absence of available data.
Do not use in sick (systemic disease, fever, etc.) or convalescent animals.
Do not use in rabbits, as sometimes lethal side effects may occur.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4. warnings specific to each target species
The veterinary drug does not prevent tick infestations.

For best flea control when there are several animals in the same household, all dogs and cats should be treated with an authorized insecticide.

Pet fleas often infest the animal's basket, bedding and resting areas, such as carpets, sofas, etc. In the event of massive infestation, these areas should be treated with a suitable insecticide and vacuumed regularly from the outset.

The influence of baths or shampoos on the efficacy of this veterinary drug has not been evaluated in cats. However, studies in dogs show that medicated shampooing, followed by thorough drying of the animal, 1 to 2 hours before application of the treatment and weekly bathing of the animal for 6 weeks do not affect the efficacy of this veterinary drug against fleas in dogs.

Avoid bathing or immersion in water for two days after application.

Used as part of a therapeutic program to control allergic dermatitis caused by flea bites, monthly applications to allergic cats and other household pets are recommended.

4.5. Special precautions for use

i) Special precautions for use on animals
It is important to ensure that the product is applied to an area where the animal cannot lick itself.
Ensure that newly treated animals do not lick each other.
Avoid contact with the animal's eyes. In the event of accidental contact with eyes, wash immediately with plenty of water.

Do not apply veterinary medicine to wounds or skin lesions.

Some ticks may remain attached. The risk of transmission of infectious diseases cannot therefore be totally excluded in unfavorable conditions.

ii) Special precautions to be taken by the person administering the veterinary drug to animals
This product may cause irritation to mucous membranes and eyes. Consequently, all contact of the product with the mouth and eyes must be avoided.
In case of accidental contact with eyes, rinse immediately with plenty of water. If eye irritation persists, seek medical advice immediately and show the instructions or labeling.
Avoid contact with fingers. In case of contact, wash fingers immediately with soap and water.
Wash hands after use.
Do not smoke, drink or eat while applying the product.
Persons with a known hypersensitivity to fipronil or any of its excipients should avoid contact with this veterinary drug.
Do not handle treated animals and do not allow children to play with treated animals until the application site is dry. It is therefore advisable not to treat animals during the day, but rather in the early evening. It is also advisable not to let treated animals sleep with their owners, especially children.
Keep pipettes in their original packaging and dispose of used pipettes immediately.

iii) Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furniture.

4.6. Adverse reactions (frequency and severity)
In the event of licking, a brief episode of hypersalivation may be observed, mainly related to the nature of the solvent.
Among adverse reactions, very rare cases of transient cutaneous reaction at the application site (desquamation, local alopecia, pruritus, erythema) as well as generalized pruritus or alopecia have been reported after use.
Very rarely, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms) or vomiting have been observed after use.
The frequency of adverse reactions is defined using the following convention
Very common (adverse reactions in more than 1 in 10 animals during treatment)
Common (between 1 and 10 animals in 100)
Uncommon (between 1 and 10 animals in 1,000)
Rare (between 1 and 10 animals in 10,000)
Very rare (less than 1 in 10,000 animals, including isolated cases).

4.7. Use during pregnancy, lactation or egg-laying
Laboratory studies with fipronil have not revealed any teratogenic or embryotoxic effects.
No studies with this drug have been carried out on females during gestation or lactation. The use of the product during gestation or lactation should only be considered after evaluation of the benefit/risk ratio by the attending veterinarian.

4.8. Drug and other interactions
None known.

4.9. Dosage and administration
Route of administration and dosage:
For local application to the skin only. For external use only.
One 0.5 mL pipette treats one cat, corresponding to a recommended minimum dose of 5 mg fipronil per kg bodyweight.
The minimum interval between two applications should not be less than 4 weeks.

For safe application:
Tear off one of the blisters. This prevents accidental opening of the rest of the blister pack, which protects unopened pipettes from moisture. Open the blister with scissors. To avoid damaging the pipette, cut along the line marked with a pair of scissors. Carefully remove the aluminium foil from the cut end and remove the pipette.
Hold the pipette vertically. Tap the pipette lightly to draw all liquid contents down into the pipette body. Fold back the top part of the pipette. The pipette can now be tilted, if required. To open the pipette, snap off the tip at the pre-cut line.
Spread the hair between the shoulder blades so that the skin is visible. Place the pipette tip on the skin and squeeze the pipette several times to empty the entire contents directly onto the skin at a single point.
Applying the solution close to the base of the head reduces the risk of the animal licking it off. Make sure that animals do not lick each other after treatment.
Care should be taken to avoid over-wetting the coat with the product, as this would result in a sticky coat appearance in the treated area. If this is the case, however, it will disappear within 24 hours of application.

4.10. Overdose (symptoms, emergency treatment, antidotes), if necessary
The toxicity of veterinary drugs applied to the skin is very low. However, the risk of adverse reactions (see "Adverse reactions") may increase in the event of overdosage, which means that animals should always be treated with the pipette size corresponding to their weight.

Specific studies on the safety of the product after repeated administration or in the event of overdosage have not been carried out, as the toxicological profile of the active substance and excipients is known.

4.11. waiting time
Not applicable.

5. Pharmacological properties

Pharmacotherapeutic group: external antiparasitics, fipronil.
ATC patent code: QP53AX15.

5.1. Pharmacodynamic properties
Fipronil is an insecticide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thus blocking the pre- and postsynaptic passage of chloride ions across the cell membrane. This results in uncontrolled central nervous system activity and insect death.
Fipronil has insecticidal activity against fleas(Ctenocephalides spp.) and acaricidal activity against ticks(Ixodes ricinus).
Fleas are killed within 24 hours.

5.2. Pharmacokinetic characteristics
The veterinary drug is distributed throughout the animal's skin within 24 to 48 hours.
Absorption of fipronil in cats after topical application is negligible.
The concentration of fipronil in the coat decreases over time.

6. Pharmaceutical information

6.1. List of excipients
Butylated hydroxyanisole (E320)
Butylated hydroxytoluene (E321)
Diethylene glycol monoethyl ether

6.2. major incompatibilities
None known.

6.3. Shelf life
Shelf life of veterinary medicinal product as packaged for sale: 30 months.

6.4. Special storage precautions
No special storage precautions are required.
Keep in original packaging.

Fiprocat 50 mg spot-on solution for cats

Official information

1. Name of the veterinary medicinal product

FIPROCAT 50 MG SPOT-ON SOLUTION FOR CATS

2. Qualitative and quantitative composition

A 0.5 mL pipette contains:
Active substance(s):
Fipronil ...................................................... 50.00 mg
Excipient(s):
Butylhydroxyanisole (E 320) .......................... 0.10 mg
Butylhydroxytoluene (E 321) .......................... 0.05 mg

For a full list of excipients, see "List of excipients".

3. Pharmaceutical form

Spot-on solution.
Clear, colorless to yellowish solution.

4. Clinical information

4.1 Target species
Cats.

4.2 Indications for use, specifying target species
In cats:
- Treatment of flea infestations(Ctenocephalides spp.).

Insecticidal efficacy prevents further flea infestation for 4 weeks.
The drug can be integrated into a treatment program for Flea Allergy Dermatitis (FAD), when this diagnosis has been made by a veterinarian.
Although immediate acaricidal efficacy has not been demonstrated for this product, persistent acaricidal activity for up to a week has been demonstrated against Ixodes ricinus ticks.
If Ixodes ricinus ticks are already present when the drug is applied, not all ticks may be killed within the first 48 hours, but they may be killed within a week.

4.3. Contraindications
Do not use on kittens under 8 weeks of age and/or weighing less than 1 kg, in the absence of available data.
Do not use in sick (systemic disease, fever, etc.) or convalescent animals.
Do not use in rabbits, as sometimes lethal side effects may occur.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4. warnings specific to each target species
The veterinary drug does not prevent tick infestations.

For best flea control when there are several animals in the same household, all dogs and cats should be treated with an authorized insecticide.

Pet fleas often infest the animal's basket, bedding and resting areas, such as carpets, sofas, etc. In the event of massive infestation, these areas should be treated with a suitable insecticide and vacuumed regularly from the outset.

The influence of baths or shampoos on the efficacy of this veterinary drug has not been evaluated in cats. However, studies in dogs show that medicated shampooing, followed by thorough drying of the animal, 1 to 2 hours before application of the treatment and weekly bathing of the animal for 6 weeks do not affect the efficacy of this veterinary drug against fleas in dogs.

Avoid bathing or immersion in water for two days after application.

Used as part of a therapeutic program to control allergic dermatitis caused by flea bites, monthly applications to allergic cats and other household pets are recommended.

4.5. Special precautions for use

i) Special precautions for use on animals
It is important to ensure that the product is applied to an area where the animal cannot lick itself.
Ensure that newly treated animals do not lick each other.
Avoid contact with the animal's eyes. In the event of accidental contact with eyes, wash immediately with plenty of water.

Do not apply veterinary medicine to wounds or skin lesions.

Some ticks may remain attached. The risk of transmission of infectious diseases cannot therefore be totally excluded in unfavorable conditions.

ii) Special precautions to be taken by the person administering the veterinary drug to animals
This product may cause irritation to mucous membranes and eyes. Consequently, all contact of the product with the mouth and eyes must be avoided.
In case of accidental contact with eyes, rinse immediately with plenty of water. If eye irritation persists, seek medical advice immediately and show the instructions or labeling.
Avoid contact with fingers. In case of contact, wash fingers immediately with soap and water.
Wash hands after use.
Do not smoke, drink or eat while applying the product.
Persons with a known hypersensitivity to fipronil or any of its excipients should avoid contact with this veterinary drug.
Do not handle treated animals and do not allow children to play with treated animals until the application site is dry. It is therefore advisable not to treat animals during the day, but rather in the early evening. It is also advisable not to let treated animals sleep with their owners, especially children.
Keep pipettes in their original packaging and dispose of used pipettes immediately.

iii) Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furniture.

4.6. Adverse reactions (frequency and severity)
In the event of licking, a brief episode of hypersalivation may be observed, mainly related to the nature of the solvent.
Among adverse reactions, very rare cases of transient cutaneous reaction at the application site (desquamation, local alopecia, pruritus, erythema) as well as generalized pruritus or alopecia have been reported after use.
Very rarely, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms) or vomiting have been observed after use.
The frequency of adverse reactions is defined using the following convention
Very common (adverse reactions in more than 1 in 10 animals during treatment)
Common (between 1 and 10 animals in 100)
Uncommon (between 1 and 10 animals in 1,000)
Rare (between 1 and 10 animals in 10,000)
Very rare (less than 1 in 10,000 animals, including isolated cases).

4.7. Use during pregnancy, lactation or egg-laying
Laboratory studies with fipronil have not revealed any teratogenic or embryotoxic effects.
No studies with this drug have been carried out on females during gestation or lactation. The use of the product during gestation or lactation should only be considered after evaluation of the benefit/risk ratio by the attending veterinarian.

4.8. Drug and other interactions
None known.

4.9. Dosage and administration
Route of administration and dosage:
For local application to the skin only. For external use only.
One 0.5 mL pipette treats one cat, corresponding to a recommended minimum dose of 5 mg fipronil per kg bodyweight.
The minimum interval between two applications should not be less than 4 weeks.

For safe application:
Tear off one of the blisters. This prevents accidental opening of the rest of the blister pack, which protects unopened pipettes from moisture. Open the blister with scissors. To avoid damaging the pipette, cut along the line marked with a pair of scissors. Carefully remove the aluminium foil from the cut end and remove the pipette.
Hold the pipette vertically. Tap the pipette lightly to draw all liquid contents down into the pipette body. Fold back the top part of the pipette. The pipette can now be tilted, if required. To open the pipette, break off the tip by bending it sharply at the pre-cut line.
Spread the hair between the shoulder blades so that the skin is visible. Place the pipette tip on the skin and squeeze the pipette several times to empty the entire contents directly onto the skin at a single point.
Applying the solution close to the base of the head reduces the risk of the animal licking it off. Make sure that animals do not lick each other after treatment.
Care should be taken to avoid over-wetting the coat with the product, as this would result in a sticky coat appearance in the treated area. If this is the case, however, it will disappear within 24 hours of application.

4.10. Overdose (symptoms, emergency treatment, antidotes), if necessary
The toxicity of veterinary drugs applied to the skin is very low. However, the risk of adverse reactions (see "Adverse reactions") may increase in the event of overdosage, which means that animals should always be treated with the pipette size corresponding to their weight.

Specific studies on the safety of the product after repeated administration or in the event of overdosage have not been carried out, as the toxicological profile of the active substance and excipients is known.

4.11. waiting time
Not applicable.

5. Pharmacological properties

Pharmacotherapeutic group: external antiparasitics, fipronil.
ATC patent code: QP53AX15.

5.1. Pharmacodynamic properties
Fipronil is an insecticide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thus blocking the pre- and postsynaptic passage of chloride ions across the cell membrane. The result is uncontrolled central nervous system activity and insect death.
Fipronil has insecticidal activity against fleas(Ctenocephalides spp.) and acaricidal activity against ticks(Ixodes ricinus).
Fleas are killed within 24 hours.

5.2. Pharmacokinetic characteristics
The veterinary drug is distributed throughout the animal's skin within 24 to 48 hours.
Absorption of fipronil in cats after topical application is negligible.
The concentration of fipronil in the coat decreases over time.

6. Pharmaceutical information

6.1. List of excipients
Butylated hydroxyanisole (E320)
Butylated hydroxytoluene (E321)
Diethylene glycol monoethyl ether

6.2. major incompatibilities
None known.

6.3. Shelf life
Shelf life of veterinary medicinal product as packaged for sale: 30 months.

6.4. Special storage precautions
No special storage precautions are required.
Store in original packaging.

Fiprocat 50 mg spot-on solution for cats

Official information

1. Name of the veterinary medicinal product

FIPROCAT 50 MG SPOT-ON SOLUTION FOR CATS

2. Qualitative and quantitative composition

A 0.5 mL pipette contains:
Active substance(s):
Fipronil ...................................................... 50.00 mg
Excipient(s):
Butylhydroxyanisole (E 320) .......................... 0.10 mg
Butylhydroxytoluene (E 321) .......................... 0.05 mg

For a full list of excipients, see "List of excipients".

3. Pharmaceutical form

Spot-on solution.
Clear, colorless to yellowish solution.

4. Clinical information

4.1 Target species
Cats.

4.2 Indications for use, specifying target species
In cats:
- Treatment of flea infestations(Ctenocephalides spp.).

Insecticidal efficacy prevents further flea infestation for 4 weeks.
The drug can be integrated into a treatment program for Flea Allergy Dermatitis (FAD), when this diagnosis has been made by a veterinarian.
Although immediate acaricidal efficacy has not been demonstrated for this product, persistent acaricidal activity for up to a week has been demonstrated against Ixodes ricinus ticks.
If Ixodes ricinus ticks are already present when the drug is applied, not all ticks may be killed within the first 48 hours, but they may be killed within a week.

4.3. Contraindications
Do not use on kittens under 8 weeks of age and/or weighing less than 1 kg, in the absence of available data.
Do not use in sick (systemic disease, fever, etc.) or convalescent animals.
Do not use in rabbits, as sometimes lethal side effects may occur.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4. warnings specific to each target species
The veterinary drug does not prevent tick infestations.

For best flea control when there are several animals in the same household, all dogs and cats should be treated with an authorized insecticide.

Pet fleas often infest the animal's basket, bedding and resting areas, such as carpets, sofas, etc. In the event of massive infestation, these areas should be treated with a suitable insecticide and vacuumed regularly from the outset.

The influence of baths or shampoos on the efficacy of this veterinary drug has not been evaluated in cats. However, studies carried out in dogs show that medicated shampooing, followed by thorough drying of the animal, 1 to 2 hours before application of the treatment and weekly bathing of the animal for 6 weeks do not affect the efficacy of this veterinary drug against fleas in dogs.

Avoid bathing or immersion in water for two days after application.

Used as part of a therapeutic program to control allergic dermatitis caused by flea bites, monthly applications to allergic cats and other household pets are recommended.

4.5. Special precautions for use

i) Special precautions for use on animals
It is important to ensure that the product is applied to an area where the animal cannot lick itself.
Ensure that newly treated animals do not lick each other.
Avoid contact with the animal's eyes. In the event of accidental contact with eyes, wash immediately with plenty of water.

Do not apply veterinary medicine to wounds or skin lesions.

Some ticks may remain attached. The risk of transmission of infectious diseases cannot therefore be totally excluded in unfavorable conditions.

ii) Special precautions to be taken by the person administering the veterinary drug to animals
This product may cause irritation to mucous membranes and eyes. Consequently, all contact of the product with the mouth and eyes must be avoided.
In case of accidental contact with eyes, rinse immediately with plenty of water. If eye irritation persists, seek medical advice immediately and show the instructions or labeling.
Avoid contact with fingers. In case of contact, wash fingers immediately with soap and water.
Wash hands after use.
Do not smoke, drink or eat while applying the product.
Persons with a known hypersensitivity to fipronil or any of its excipients should avoid contact with this veterinary drug.
Do not handle treated animals and do not allow children to play with treated animals until the application site is dry. It is therefore advisable not to treat animals during the day, but rather in the early evening. It is also advisable not to let treated animals sleep with their owners, especially children.
Keep pipettes in their original packaging and dispose of used pipettes immediately.

iii) Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furniture.

4.6. Adverse reactions (frequency and severity)
In the event of licking, a brief episode of hypersalivation may be observed, mainly related to the nature of the solvent.
Among adverse reactions, very rare cases of transient cutaneous reaction at the application site (desquamation, local alopecia, pruritus, erythema) as well as generalized pruritus or alopecia have been reported after use.
Very rarely, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms) or vomiting have been observed after use.
The frequency of adverse reactions is defined using the following convention
Very common (adverse reactions in more than 1 in 10 animals during treatment)
Common (between 1 and 10 animals in 100)
Uncommon (between 1 and 10 animals in 1,000)
Rare (between 1 and 10 animals in 10,000)
Very rare (less than 1 in 10,000 animals, including isolated cases).

4.7. Use during pregnancy, lactation or egg-laying
Laboratory studies with fipronil have not revealed any teratogenic or embryotoxic effects.
No studies with this drug have been carried out on females during gestation or lactation. The use of the product during gestation or lactation should only be considered after evaluation of the benefit/risk ratio by the attending veterinarian.

4.8. Drug and other interactions
None known.

4.9. Dosage and administration
Route of administration and dosage:
For local application to the skin only. For external use only.
One 0.5 mL pipette treats one cat, corresponding to a recommended minimum dose of 5 mg fipronil per kg bodyweight.
The minimum interval between two applications should not be less than 4 weeks.

For safe application:
Tear off one of the blisters. This prevents accidental opening of the rest of the blister pack, which protects unopened pipettes from moisture. Open the blister with scissors. To avoid damaging the pipette, cut along the line marked with a pair of scissors. Carefully remove the aluminium foil from the cut end and remove the pipette.
Hold the pipette vertically. Tap the pipette lightly to draw all liquid contents down into the pipette body. Fold back the top part of the pipette. The pipette can now be tilted, if required. To open the pipette, snap off the tip at the pre-cut line.
Spread the hair between the shoulder blades so that the skin is visible. Place the pipette tip on the skin and squeeze the pipette several times to empty the entire contents directly onto the skin at a single point.
Applying the solution close to the base of the head reduces the risk of the animal licking it off. Make sure that animals do not lick each other after treatment.
Care should be taken to avoid over-wetting the coat with the product, as this would result in a sticky appearance of the treated area. If this is the case, however, it will disappear within 24 hours of application.

4.10. Overdose (symptoms, emergency treatment, antidotes), if necessary
The toxicity of veterinary drugs applied to the skin is very low. However, the risk of adverse reactions (see "Adverse reactions") may increase in the event of overdosage, which means that animals should always be treated with the pipette size corresponding to their weight.

Specific studies on the safety of the product after repeated administration or in the event of overdosage have not been carried out, as the toxicological profile of the active substance and excipients is known.

4.11. waiting time
Not applicable.

5. Pharmacological properties

Pharmacotherapeutic group: external antiparasitics, fipronil.
ATC patent code: QP53AX15.

5.1. Pharmacodynamic properties
Fipronil is an insecticide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thus blocking the pre- and postsynaptic passage of chloride ions across the cell membrane. This results in uncontrolled central nervous system activity and insect death.
Fipronil has insecticidal activity against fleas(Ctenocephalides spp.) and acaricidal activity against ticks(Ixodes ricinus).
Fleas are killed within 24 hours.

5.2. Pharmacokinetic characteristics
The veterinary drug is distributed throughout the animal's skin within 24 to 48 hours.
Absorption of fipronil in cats after topical application is negligible.
The concentration of fipronil in the coat decreases over time.

6. Pharmaceutical information

6.1. List of excipients
Butylated hydroxyanisole (E320)
Butylated hydroxytoluene (E321)
Diethylene glycol monoethyl ether

6.2. major incompatibilities
None known.

6.3. Shelf life
Shelf life of veterinary medicinal product as packaged for sale: 30 months.

6.4. Special storage precautions
No special storage precautions are required.
Keep in original packaging.

Fiprocat 50 mg spot-on solution for cats

Official information

1. Name of the veterinary medicinal product

FIPROCAT 50 MG SPOT-ON SOLUTION FOR CATS

2. Qualitative and quantitative composition

A 0.5 mL pipette contains:
Active substance(s):
Fipronil ...................................................... 50.00 mg
Excipient(s):
Butylhydroxyanisole (E 320) .......................... 0.10 mg
Butylhydroxytoluene (E 321) .......................... 0.05 mg

For a full list of excipients, see "List of excipients".

3. Pharmaceutical form

Spot-on solution.
Clear, colorless to yellowish solution.

4. Clinical information

4.1 Target species
Cats.

4.2 Indications for use, specifying target species
In cats:
- Treatment of flea infestations(Ctenocephalides spp.).

Insecticidal efficacy prevents further flea infestation for 4 weeks.
The drug can be integrated into a treatment program for Flea Allergy Dermatitis (FAD), when this diagnosis has been made by a veterinarian.
Although immediate acaricidal efficacy has not been demonstrated for this product, persistent acaricidal activity for up to a week has been demonstrated against Ixodes ricinus ticks.
If Ixodes ricinus ticks are already present when the drug is applied, not all ticks may be killed within the first 48 hours, but they may be killed within a week.

4.3. Contraindications
Do not use on kittens under 8 weeks of age and/or weighing less than 1 kg, in the absence of available data.
Do not use in sick (systemic disease, fever, etc.) or convalescent animals.
Do not use in rabbits, as sometimes lethal side effects may occur.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4. warnings specific to each target species
The veterinary drug does not prevent tick infestations.

For best flea control when there are several animals in the same household, all dogs and cats should be treated with an authorized insecticide.

Pet fleas often infest the animal's basket, bedding and resting areas, such as carpets, sofas, etc. In the event of massive infestation, these areas should be treated with a suitable insecticide and vacuumed regularly from the outset.

The influence of baths or shampoos on the efficacy of this veterinary drug has not been evaluated in cats. However, studies in dogs show that medicated shampooing, followed by thorough drying of the animal, 1 to 2 hours before application of the treatment and weekly bathing of the animal for 6 weeks do not affect the efficacy of this veterinary drug against fleas in dogs.

Avoid bathing or immersion in water for two days after application.

Used as part of a therapeutic program to control allergic dermatitis caused by flea bites, monthly applications to allergic cats and other household pets are recommended.

4.5. Special precautions for use

i) Special precautions for use on animals
It is important to ensure that the product is applied to an area where the animal cannot lick itself.
Ensure that newly treated animals do not lick each other.
Avoid contact with the animal's eyes. In the event of accidental contact with eyes, wash immediately with plenty of water.

Do not apply veterinary medicine to wounds or skin lesions.

Some ticks may remain attached. The risk of transmission of infectious diseases cannot therefore be totally excluded in unfavorable conditions.

ii) Special precautions to be taken by the person administering the veterinary drug to animals
This product may cause irritation to mucous membranes and eyes. Consequently, all contact of the product with the mouth and eyes must be avoided.
In case of accidental contact with eyes, rinse immediately with plenty of water. If eye irritation persists, seek medical advice immediately and show the instructions or labeling.
Avoid contact with fingers. In case of contact, wash fingers immediately with soap and water.
Wash hands after use.
Do not smoke, drink or eat while applying the product.
Persons with a known hypersensitivity to fipronil or any of its excipients should avoid contact with this veterinary drug.
Do not handle treated animals and do not allow children to play with treated animals until the application site is dry. It is therefore advisable not to treat animals during the day, but rather in the early evening. It is also advisable not to let treated animals sleep with their owners, especially children.
Keep pipettes in their original packaging and dispose of used pipettes immediately.

iii) Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furniture.

4.6. Adverse reactions (frequency and severity)
In the event of licking, a brief episode of hypersalivation may be observed, mainly related to the nature of the solvent.
Among adverse reactions, very rare cases of transient cutaneous reaction at the application site (desquamation, local alopecia, pruritus, erythema) as well as generalized pruritus or alopecia have been reported after use.
Very rarely, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms) or vomiting have been observed after use.
The frequency of adverse reactions is defined using the following convention
Very common (adverse reactions in more than 1 in 10 animals during treatment)
Common (between 1 and 10 animals in 100)
Uncommon (between 1 and 10 animals in 1,000)
Rare (between 1 and 10 animals in 10,000)
Very rare (less than 1 in 10,000 animals, including isolated cases).

4.7. Use during pregnancy, lactation or egg-laying
Laboratory studies with fipronil have not revealed any teratogenic or embryotoxic effects.
No studies with this drug have been carried out on females during gestation or lactation. The use of the product during gestation or lactation should only be considered after evaluation of the benefit/risk ratio by the attending veterinarian.

4.8. Drug and other interactions
None known.

4.9. Dosage and administration
Route of administration and dosage:
For local application to the skin only. For external use only.
One 0.5 mL pipette treats one cat, corresponding to a recommended minimum dose of 5 mg fipronil per kg bodyweight.
The minimum interval between two applications should not be less than 4 weeks.

For safe application:
Tear off one of the blisters. This prevents accidental opening of the rest of the blister pack, which protects unopened pipettes from moisture. Open the blister with scissors. To avoid damaging the pipette, cut along the line marked with a pair of scissors. Carefully remove the aluminium foil from the cut end and remove the pipette.
Hold the pipette vertically. Tap the pipette lightly to draw all liquid contents down into the pipette body. Fold back the top part of the pipette. The pipette can now be tilted, if required. To open the pipette, snap off the tip at the pre-cut line.
Spread the hair between the shoulder blades so that the skin is visible. Place the pipette tip on the skin and squeeze the pipette several times to empty the entire contents directly onto the skin at a single point.
Applying the solution close to the base of the head reduces the risk of the animal licking it off. Make sure that animals do not lick each other after treatment.
Care should be taken to avoid over-wetting the coat with the product, as this would result in a sticky coat appearance in the treated area. If this is the case, however, it will disappear within 24 hours of application.

4.10. Overdose (symptoms, emergency treatment, antidotes), if necessary
The toxicity of veterinary drugs applied to the skin is very low. However, the risk of adverse reactions (see "Adverse reactions") may increase in the event of overdosage, which means that animals should always be treated with the pipette size corresponding to their weight.

Specific studies on the safety of the product after repeated administration or in the event of overdosage have not been carried out, as the toxicological profile of the active substance and excipients is known.

4.11. waiting time
Not applicable.

5. Pharmacological properties

Pharmacotherapeutic group: external antiparasitics, fipronil.
ATC patent code: QP53AX15.

5.1. Pharmacodynamic properties
Fipronil is an insecticide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thus blocking the pre- and postsynaptic passage of chloride ions across the cell membrane. This results in uncontrolled central nervous system activity and insect death.
Fipronil has insecticidal activity against fleas(Ctenocephalides spp.) and acaricidal activity against ticks(Ixodes ricinus).
Fleas are killed within 24 hours.

5.2. Pharmacokinetic characteristics
The veterinary drug is distributed throughout the animal's skin within 24 to 48 hours.
Absorption of fipronil in cats after topical application is negligible.
The concentration of fipronil in the coat decreases over time.

6. Pharmaceutical information

6.1. List of excipients
Butylated hydroxyanisole (E320)
Butylated hydroxytoluene (E321)
Diethylene glycol monoethyl ether

6.2. major incompatibilities
None known.

6.3. Shelf life
Shelf life of veterinary medicinal product as packaged for sale: 30 months.

6.4. Special storage precautions
No special storage precautions are required.
Keep in original packaging.