Products

PACKAGE LEAFLET FOR Cardboard box with 3 pipettes

Frontline Tri-Act spot-on solution for dogs 10-20 kg

DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Spot-on solution.

Clear, colourless to brownish-yellow solution.

Active substances/Excipients:

See section "Dosage for each target species"

TARGET SPECIES

Dogs

Caution!!!

Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species that may be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.

INDICATION (INDICATIONS)

For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, flies, and/or mosquitoes is required.

For the treatment and prevention of flea infestations with Ctenocephalides felis and the prevention of flea infestations with Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single

treatment prevents new flea infestation for 4 weeks. The product can be part of the treatment strategy for the control of flea allergy dermatitis if this diagnosis has

been established by a veterinarian.

The product has repellent efficacy against ticks (Dermacentor reticulatus) from 7 days up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.

The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus species, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.

The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.

The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).

The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.

The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.

CONTRAINDICATIONS

Do not use on sick or convalescing animals.

Do not use on cats and rabbits as it may cause adverse reactions and even death.

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Among the suspected, very rare adverse reactions, transient skin reactions at the application site (skin discolouration, local alopecia, pruritus, erythema) and generalised pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.

Mild hypersalivation and vomiting may occur if the product is ingested, for example, if the animal licks the application area.

If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION

Topical application on the skin (spot-on).

The following table defines which pipette should be used depending on the dog's weight:

Active ingredients Excipients

Frontline Tri-Act spot- Volume of unit Fipronil (mg) Permethrin Butylhydroxytoluene

on for dogs dosed (mg) (E321) (mg)

Very small dogs 2-5kg 0.5 33.8 252.4 0.563

Small dogs 5-10kg 1 67.6 504.8 1.125

Medium dogs 10-20kg 2 135.2 1009.6 2.250

Large dogs 20-40kg 4 270.4 2019.2 4.500

XL dogs 40-60kg 6 405.6 3028.8 6.750

Dogs > 60 kg Use the appropriate combination of pipettes

Treatment regimen

The product should be used after confirmation of infestation or risk of infestation with fleas and/or ticks, simultaneously with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or flies.

Depending on the recurrence of the risk of infestation with these ectoparasites, repeated treatment may be established. In these cases, the minimum treatment interval is at least 4 weeks.

ADVICE ON CORRECT ADMINISTRATION

Select the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg, the necessary combination of pipettes should be used until the appropriate quantity for the dog's weight is reached.

The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site. These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.

Remove the blister foil from the packaging and tear off one blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.

Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the pipette tip on the skin.

Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.

For best results, ensure the product is applied directly to the skin and not to the fur.

WITHDRAWAL PERIOD

Not applicable

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and reach of children.

Store in the original packaging.

Do not store above 25 °C

Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.

SPECIAL WARNING(S)

Special warnings for each target species

A single tick or a mosquito or sandfly bite may already be present on the animal. Therefore, the transmission of pathogens by these arthropods cannot be excluded if conditions are favourable.

The product remains effective against fleas when treated animals occasionally enter water (e.g., swimming, bathing). However, dogs should not be allowed to swim or be shampooed for 48 hours after treatment application.

Avoid swimming or frequent shampooing of treated dogs as this may affect the maintenance of product efficacy.

In order to reduce re-infestation due to the emergence of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same environment should be treated with a veterinary medicinal product appropriate for their species.

To reduce the risk of environmental infestation, it is recommended to use an additional appropriate treatment for the environment in which the animals live, against fleas and their developmental stages.

Special precautions for use in animals

In the absence of specific studies, the use of this product is not recommended for dogs less than 8 weeks old or weighing less than 2 kg.

Avoid contact of the product with the animal's eyes.

It is very important to ensure that the product is applied in an area where the animal cannot lick the product, and also to ensure that animals do not lick each other after

treatment.

Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species that may be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.

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

For veterinary use only.

This product may cause skin and eye irritation. Consequently, contact of the product with skin or eyes should be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if eyes become irritated during administration of the product, immediate abundant washing with water is recommended. If ophthalmic irritation persists, seek medical advice.

Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.

The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of swallowing, rinse mouth with water and seek medical advice if you feel unwell.

As the excipient N-methylpyrrolidone may cause foetotoxicity and teratogenicity following prolonged exposure, it is recommended that pregnant women wear gloves to avoid contact with the product.

Avoid handling the animal until the application site has dried. Children should also not play with the animals until the fur is dry.

Therefore, it is recommended that animals are not treated during the day but in the evening, and treated animals should sleep alone during the night, not with owners and especially not with children.

Store pipettes in the original packaging, and once used, empty pipettes should be disposed of immediately in an appropriate manner to prevent subsequent access.

Other precautions

The product may adversely affect aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.

Use during pregnancy and lactation

Laboratory studies with fipronil and permethrin have not produced any teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.

N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.

Use only based on a benefit/risk assessment by the veterinary surgeon.

Overdose

Safety of use was evaluated in healthy adult dogs treated with a dose up to 5 times the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Known adverse reactions may include mild neurological symptoms,

vomiting and diarrhoea. These symptoms are transient and usually resolve without treatment within 1-2 days. Animals should always be treated with the pipette appropriate for their weight.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such products

should be disposed of in accordance with local requirements.

Do not contaminate ponds, watercourses or ditches with this product or empty pipettes.

OTHER INFORMATION

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas within 24 hours,

ticks and lice within 48 hours of exposure.

Permethrin belongs to the Type I pyrethroid class, which are acaricides and insecticides with repellent activity.

Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.

PACKAGE LEAFLET FOR Cardboard box with 3 pipettes

Frontline Tri-Act spot-on solution for dogs 2-5 kg

DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Spot-on solution.

Clear, colourless to brownish-yellow solution.

Active substances/Excipients:

See section "dosage for each target species"

TARGET SPECIES

Dogs

Caution!!!

Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separated from treated dogs until the application site is dry.

It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.

INDICATION (INDICATIONS)

For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, stable flies and/or mosquitoes is needed.

For the treatment and prevention of Ctenocephalides felis flea infestations and the prevention of Ctenocephalides canis flea infestations. The product kills C. felis fleas on the animal within 24 hours. A single

treatment prevents a new flea infestation for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has

been established by a veterinarian.

The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.

The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus species, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.

The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.

The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).

The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.

The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.

CONTRAINDICATIONS

Do not use on sick or convalescent animals.

Do not use on cats and rabbits as it may cause adverse reactions and even death.

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Among the very rare suspected adverse reactions, transient reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalised pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.

Slight hypersalivation and vomiting may occur if the product is ingested, should the animal lick the application area.

If you notice any serious reactions or other effects not mentioned in this package leaflet, please inform your veterinarian.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Topical administration to the skin (spot-on).

The following table defines which pipette should be used depending on the dog's weight:

Active ingredients Excipients

Frontline Tri-Act spot-on solution for dogs Dosed unit volume Fipronil (mg) Permethrin (mg) Butylhydroxytoluene (E321) (mg)

Very small dogs 2-5kg 0.5 33.8 252.4 0.563

Small dogs 5-10kg 1 67.6 504.8 1.125

Medium dogs 10-20kg 2 135.2 1009.6 2.250

Large dogs 20-40kg 4 270.4 2019.2 4.500

XL dogs 40-60kg 6 405.6 3028.8 6.750

Dogs > 60 kg Use the appropriate combination of pipettes

Treatment scheme

The product should be used after confirming infestation or risk of infestation with fleas and/or ticks, concurrently with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or stable flies.

Depending on the recurrence of the risk of infestation with these ectoparasites, repeated treatment may be established. In these cases, the minimum treatment interval is at least 4 weeks.

ADVICE ON CORRECT ADMINISTRATION

Choose the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg, the necessary combination of pipettes will be used until the appropriate quantity for the dog's weight is reached.

The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site.

These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.

Remove the blister foil from the package and peel off a blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.

Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the tip of the pipette on the skin.

Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.

To achieve the best results, make sure you apply the product directly to the skin and not to the fur.

WITHDRAWAL PERIOD

Not applicable

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and reach of children.

Store in the original packaging.

Do not store above 25 °C

Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.

SPECIAL WARNING(S)

Special warnings for each target species

A single tick or a mosquito or sandfly bite may already be attached to the animal. For this reason, the transmission of pathogens by these arthropods cannot be excluded if conditions are favourable.

The product remains effective against fleas when treated animals occasionally enter water (e.g. swimming, bathing). However, dogs should not be allowed to swim and should not be shampooed for 48 hours after treatment.

Avoid frequent swimming or shampooing of treated dogs as this may affect the maintenance of product efficacy.

To reduce re-infestation due to the emergence of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same space should be treated with a veterinary medicinal product suitable for their species.

To reduce the risk of environmental infestation, it is recommended to use additional appropriate environmental treatment

against fleas and their developmental stages.

Special precautions for use in animals

In the absence of specific studies, the use of this product is not recommended for dogs younger than 8 weeks or weighing less than 2 kg.

Avoid contact of the product with the animal's eyes.

It is very important to ensure that the product is applied in an area where the animal cannot lick the product and also to ensure that animals do not lick each other after

treatment.

Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separated from treated dogs until the application site is dry.

It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.

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

For veterinary use only.

This product may cause skin and eye irritation. Therefore, contact of the product with the skin or eyes must be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if the eyes become irritated during product administration, immediate thorough washing with water is recommended. If ophthalmic irritation persists, seek medical advice.

Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.

The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.

As the excipient N-methylpyrrolidone can cause fetotoxicity and teratogenicity following prolonged exposure, pregnant women are advised to wear gloves to avoid contact with the product.

Avoid handling the animal until the application site is dry; children should also not play with animals until their fur is dry.

Therefore, it is recommended that animals are not treated during the day but in the evening, and that treated animals sleep alone during the night, not with their owners and especially not with children.

Keep pipettes in the original packaging and, once used, empty pipettes must be disposed of immediately in an appropriate manner to prevent further access.

Other precautions

The product can have harmful effects on aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.

Use during pregnancy and lactation

Laboratory studies with fipronil and permethrin produced no teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.

N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.

Use only based on a benefit/risk assessment by the veterinarian.

Overdose

Safety of use was evaluated in healthy adult dogs treated with a dose up to 5 times higher than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Among the known adverse reactions, mild neurological symptoms,

vomiting, and diarrhea may occur. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette corresponding to their weight.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF APPLICABLE

Any unused veterinary medicinal product or waste material derived from such products

must be disposed of in accordance with local requirements.

Do not contaminate lakes, watercourses, or drains with this product or empty pipettes.

OTHER INFORMATION

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas in 24

hours, ticks and lice in 48 hours after exposure.

Permethrin belongs to type I pyrethroids, which are acaricides and insecticides with repellent activity.

Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.

PACKAGE LEAFLET FOR Cardboard box with 3 pipettes

Frontline Tri-Act spot-on solution for dogs 20-40 kg

DECLARATION OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Spot-on solution.

Clear, colourless to brown-yellow solution.

Active substances/Excipients:

See section "dosage for each target species"

TARGET SPECIES

Dogs

Warning!!!

Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species that may be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and urgently seek veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, immediately seek veterinary advice.

INDICATION(S)

For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, flies, and/or mosquitoes is required.

For the treatment and prevention of flea infestations with Ctenocephalides felis and the prevention of flea infestations with Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single

treatment prevents new flea infestations for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has

been established by a veterinarian.

The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and lasting up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.

The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.

The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.

The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).

The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.

The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.

CONTRAINDICATIONS

Do not use on sick or convalescent animals.

Do not use on cats and rabbits as it may cause adverse reactions and even death.

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Among the suspected, very rare adverse reactions reported after use were transient reactions

on the skin at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalized pruritus or alopecia. Also reported were hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremor, depression, other neurological reactions) or vomiting.

Slight hypersalivation and vomiting may occur if the product is ingested, if the animal licks the application area.

If you notice any serious reactions or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Topical application to the skin (spot-on).

The following table defines which pipette should be used depending on the dog's weight:

Active ingredients Excipients

Frontline Tri-Act spot-on solution for dogs Unit volume Fipronil (mg) Permethrin Butylhydroxytoluene

dosed (mg) (E321) (mg)

Very small dogs 2-5kg 0.5 33.8 252.4 0.563

Small dogs 5-10kg 1 67.6 504.8 1.125

Medium dogs 10-20kg 2 135.2 1009.6 2.250

Large dogs 20-40kg 4 270.4 2019.2 4.500

XL dogs 40-60kg 6 405.6 3028.8 6.750

Dogs > 60 kg Use the appropriate combination of pipettes

Treatment regimen

The product should be used following confirmation of infestation or risk of infestation with fleas and/or ticks, simultaneously with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or flies.

Depending on the recurrence of the risk of infestation with these ectoparasites, treatment repetition can be established. In these cases, the minimum treatment interval is at least 4 weeks.

RECOMMENDATIONS FOR CORRECT ADMINISTRATION

Select the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg, the necessary combination of pipettes should be used to achieve the appropriate amount for the dog's weight.

The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site. These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.

Remove the blister foil from the package and detach one blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.

Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the pipette tip on the skin.

Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.

To achieve the best results, ensure that the product is applied directly to the skin and not to the fur.

WITHDRAWAL PERIOD

Not applicable

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and reach of children.

Store in the original packaging.

Do not store above 25 °C

Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.

SPECIAL WARNING(S)

Special warnings for each target species

A single tick may already be attached to the animal or a mosquito or sandfly bite may be present. For this reason, the transmission of pathogens by these arthropods cannot be excluded if conditions are favorable.

The product remains effective against fleas when treated animals occasionally enter water (e.g., swimming, bathing). However, dogs should not be allowed to swim or be shampooed for 48 hours after treatment application.

Avoid frequent swimming or shampooing of treated dogs as this may affect the maintenance of product efficacy.

In order to reduce re-infestation due to the emergence of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same environment should be treated with a veterinary medicinal product suitable for their species.

To reduce the risk of environmental infestation, the use of an additional treatment is recommended

appropriate to the environment in which the animals live, against fleas and their developmental stages.

Special precautions for use in animals

In the absence of specific studies, the use of this product is not recommended for dogs less than 8 weeks of age or weighing less than 2 kg.

Avoid contact of the product with the animal's eyes.

It is very important to ensure that the product is applied to an area where the animal cannot lick the product and also to ensure that animals do not lick each other after

treatment.

Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species that may be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and urgently seek veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, immediately seek veterinary advice.

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

For veterinary use only.

This product may cause skin and eye irritation. Therefore, contact of the product with skin or eyes must be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if eyes become irritated during product administration, immediate thorough washing with water is recommended. If eye irritation persists, seek medical advice.

Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.

The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.

As the excipient N-methylpyrrolidone may cause foetotoxicity and teratogenicity following prolonged exposure, pregnant women are advised to wear gloves to avoid contact with the product.

Avoid handling the animal until the application site has dried; also, children should not play with the animals until their fur is dry.

Therefore, it is recommended that animals should not be treated during the day but in the evening, and during the night treated animals should sleep alone, not with owners and especially not with children.

Keep pipettes in their original packaging and once used, empty pipettes should be disposed of immediately in an appropriate manner, to prevent further access.

Other precautions

The product may have adverse effects on aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.

Use during pregnancy and lactation

Laboratory studies with fipronil and permethrin did not produce any teratogenic or embryotoxic effects. No studies have been performed with this product on animals during pregnancy or lactation.

N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.

Use only after a benefit/risk assessment by the veterinary surgeon.

Overdose

Safety for use has been evaluated in healthy adult dogs treated with a dose up to 5 times higher

than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks of age, treated once). Among the known adverse reactions, mild neurological symptoms,

vomiting, and diarrhoea may occur. These symptoms are transient and usually resolve without treatment within 1-2 days. Animals should always be treated with the pipette appropriate for their weight.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF APPLICABLE

Any unused veterinary medicinal product or waste materials derived from such products

should be disposed of in accordance with local requirements.

Do not contaminate lakes, watercourses or drains with this product or empty pipettes.

OTHER INFORMATION

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas within 24

hours, ticks and lice within 48 hours of exposure.

Permethrin belongs to the Type I class of pyrethroids, which are acaricides and insecticides with repellent activity.

Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.

PACKAGE LEAFLET FOR Cardboard box with 3 pipettes

Frontline Tri-Act spot-on solution for dogs 40-60 kg

STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Spot-on solution.

Clear, colourless to yellow-brown solution.

Active substances/Excipients:

See section "dosage for each target species"

TARGET SPECIES

Dogs

Caution!!!

Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.

INDICATION (INDICATIONS)

For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, flies and/or mosquitoes is required.

For the treatment and prevention of infestations with fleas Ctenocephalides felis and prevention of infestations with fleas Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single

treatment prevents new flea infestation for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has been

established by the veterinarian.

The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and up to 4 weeks after treatment. However, a single tick can attach and detach within the first 24 hours after infestation.

The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus species, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.

The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.

The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).

The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.

The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.

CONTRAINDICATIONS

Do not use on sick or convalescing animals.

Do not use on cats and rabbits as it can cause adverse reactions and even death.

Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalized pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.

Mild hypersalivation and vomiting may occur if the product is ingested, if the animal licks the application site.

If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION

Topical administration to the skin (spot-on).

The following table defines which pipette should be used depending on the dog's weight:

Active ingredients Excipients

Frontline Tri-Act spot-on solution for dogs. Volume of dosed unit. Fipronil (mg) Permethrin (mg) Butylated hydroxytoluene (E321) (mg)

Very small dogs 2-5kg 0.5 33.8 252.4 0.563

Small dogs 5-10kg 1 67.6 504.8 1.125

Medium dogs 10-20kg 2 135.2 1009.6 2.250

Large dogs 20-40kg 4 270.4 2019.2 4.500

XL dogs 40-60kg 6 405.6 3028.8 6.750

Dogs > 60 kg Use the appropriate combination of pipettes

Treatment scheme

The product should be used after confirmation of infestation or risk of infestation with fleas and/or ticks, along with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or flies.

Depending on the recurrence of infestation risk with these ectoparasites, treatment repetition can also be established. In these cases, the minimum treatment interval is at least 4 weeks.

RECOMMENDATIONS FOR CORRECT ADMINISTRATION

Select the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg,

the necessary combination of pipettes should be used until the appropriate quantity for the dog's weight is reached.

The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site.

These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.

Remove the blister foil from the packaging and detach one blister. Use scissors to cut the blister along the dotted line to remove the pipette, or fold the marked corner and tear it open.

Hold the pipette upright, away from your face or body, and cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the tip of the pipette on the skin.

Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.

To achieve the best results, ensure that the product is applied directly to the skin and not to the fur.

WITHDRAWAL PERIOD

Not applicable

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and reach of children.

Store in the original packaging.

Do not store above 25 °C.

Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.

SPECIAL WARNING(S)

Special warnings for each target species

A single tick or a bite from a mosquito or sandfly may already be present on the animal. For this reason, the transmission of pathogens by these arthropods cannot be excluded if conditions are favourable.

The product remains effective against fleas when treated animals occasionally enter water (e.g. swimming, bathing). However, dogs should not be allowed to swim or be shampooed for 48 hours after treatment application.

Avoid swimming or frequent shampooing of treated dogs as this may affect the maintenance of product efficacy.

To reduce re-infestation due to the appearance of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same area should be treated with a veterinary medicinal product suitable for their species.

To reduce the risk of environmental infestation, it is recommended to use additional appropriate treatment

for the animals' environment, against fleas and their developmental stages.

Special precautions for use in animals

In the absence of specific studies, the use of this product is not recommended for dogs younger than 8 weeks or weighing less than 2 kg.

Avoid contact of the product with the animal's eyes.

It is very important to ensure that the product is applied in an area where the animal cannot lick the product, and also to ensure that animals do not lick each other after

treatment.

Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.

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

For veterinary use only.

This product may cause skin and eye irritation. Therefore, contact of the product with skin or eyes should be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if the eyes become irritated during product administration, immediate thorough washing with water is recommended. If eye irritation persists, seek medical advice.

Persons with known hypersensitivity to fipronil or/and permethrin should avoid contact with this product.

The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat while applying the product. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.

As the excipient N-methylpyrrolidone may cause foetotoxicity and teratogenicity following prolonged exposure, pregnant women are advised to wear gloves to avoid contact with the product.

Avoid handling the animal until the application site is dry; children should also not play with the animals until the fur is dry.

Therefore, it is recommended that animals are not treated during the day but in the evening, and that treated animals sleep alone during the night, not with their owners and especially not with children.

Keep pipettes in the original packaging and once used, empty pipettes should be disposed of immediately in an appropriate manner to prevent subsequent access.

Other precautions

The product may be harmful to aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.

Use during pregnancy and lactation

Laboratory studies with fipronil and permethrin produced no teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.

N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.

Use only after a benefit/risk assessment by the veterinarian.

Overdose

Safety of use has been evaluated in healthy adult dogs treated with a dose up to 5 times higher than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Known adverse reactions may include mild neurological symptoms, vomiting and diarrhoea. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette corresponding to their weight.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products

should be disposed of in accordance with local requirements.

Do not contaminate lakes, watercourses or drains with this product or empty pipettes.

OTHER INFORMATION

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas in 24

hours, ticks and lice in 48 hours after exposure.

Permethrin belongs to type I pyrethroids, which are acaricides and insecticides with repellent activity.

Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.

PACKAGE LEAFLET FOR Cardboard box with 3 pipettes

Frontline Tri-Act spot-on solution for dogs 5-10 kg

DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Spot-on solution.

Clear, colorless to brownish-yellow solution.

Active substances/Excipients:

See "dosage for each target species" section

TARGET SPECIES

Dogs

Caution!!!

Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and urgently seek veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.

INDICATION(S)

For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, stable flies and/or mosquitoes is required.

For the treatment and prevention of flea infestations by Ctenocephalides felis and the prevention of flea infestations by Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single

treatment prevents new flea infestations for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has

been established by the veterinarian.

The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.

The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.

The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.

The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).

The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.

The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.

CONTRAINDICATIONS

Do not use on sick or convalescing animals.

Do not use on cats and rabbits as it may cause adverse reactions and even death.

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Among the suspected, very rare adverse reactions reported after use, transient reactions have occurred

on the skin at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalized pruritus or alopecia. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.

Mild hypersalivation and vomiting may occur if the product is ingested, if the animal licks the application site.

If you notice any serious reactions or other effects not mentioned in this package leaflet, please inform your veterinarian.

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION

Topical application to the skin (spot-on).

The following table defines which pipette should be used depending on the dog's weight:

Active Ingredients Excipients

Frontline Tri-Act spot-on Volume of unit Fipronil (mg) Permethrin Butylhydroxytoluene

solution for dogs dosed (mg) (E321) (mg)

Very small dogs 2-5kg 0.5 33.8 252.4 0.563

Small dogs 5-10kg 1 67.6 504.8 1.125

Medium dogs 10-20kg 2 135.2 1009.6 2.250

Large dogs 20-40kg 4 270.4 2019.2 4.500

XL dogs 40-60kg 6 405.6 3028.8 6.750

Dogs > 60 kg Use the appropriate combination of pipettes

Treatment schedule

The product should be used after confirmation of infestation or risk of infestation with fleas and/or ticks, simultaneously with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or stable flies.

Depending on the recurrence of the risk of infestation with these ectoparasites, repeated treatment may also be established. In these cases, the minimum treatment interval is at least 4 weeks.

ADVICE ON CORRECT ADMINISTRATION

Choose the pipette appropriate for the dog's weight. For dogs weighing over 60 kg, the necessary combination of pipettes should be used until the amount appropriate for the dog's weight is reached.

The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site.

These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.

Remove the blister foil from the package and detach one blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.

Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur so that the skin is visible. Position the tip of the pipette on the skin.

Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.

To obtain the best results, make sure to apply the product directly to the skin and not to the fur.

WAITING PERIOD

Not applicable

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and reach of children.

Store in the original packaging.

Do not store above 25 °C

Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.

SPECIAL WARNING(S)

Special warnings for each target species

A single tick or a bite from a mosquito or sandfly may already be present on the animal. For this reason, the transmission of pathogens by these arthropods cannot be excluded, if conditions are favorable.

The product remains effective against fleas when treated animals occasionally enter water (e.g. swimming, bathing). However, dogs should not be allowed to swim and should not be shampooed for 48 hours after treatment.

Avoid swimming or frequent shampooing of treated dogs as this may affect the maintenance of the product's efficacy.

To reduce re-infestation due to the appearance of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same area should be treated with a veterinary medicinal product suitable for their species.

To reduce the risk of environmental infestation, it is recommended to use an additional treatment

appropriate for the environment in which the animals live, against fleas and their developmental stages.

Special precautions for use in animals

In the absence of specific studies, the use of this product is not recommended for dogs less than 8 weeks old or weighing less than 2 kg.

Avoid contact of the product with the animal's eyes.

It is very important to ensure that the product is applied in an area where the animal cannot lick the product and also to ensure that animals do not lick each other after

treatment.

Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.

In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and urgently seek veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.

It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.

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

For veterinary use only.

This product can cause skin and eye irritation. Therefore, contact of the product with the skin or eyes must be avoided.

Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if the eyes become irritated during administration of the product, immediate rinsing with plenty of water is recommended. If ocular irritation persists, seek medical advice.

Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.

The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.

As the excipient N-methylpyrrolidone can cause fetotoxicity and teratogenicity after prolonged exposure, it is recommended that pregnant women wear gloves to avoid contact with the product.

Avoid handling the animal until the application site is dry; children should also not play with the animals until their fur is dry.

Therefore, it is recommended that animals are not treated during the day but in the evening, and during the night, treated animals should sleep alone, not with owners and especially not with children.

Keep pipettes in the original packaging and once used, empty pipettes must be disposed of immediately in an appropriate manner, to prevent subsequent access.

Other precautions

The product can be harmful to aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.

Use during pregnancy and lactation

Laboratory studies with fipronil and permethrin produced no teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.

N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.

Use only after a benefit/risk assessment by the veterinarian.

Overdose

Safety of use has been evaluated in healthy adult dogs treated with a dose up to 5 times higher

than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Known adverse reactions may include mild neurological symptoms,

vomiting and diarrhea. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette corresponding to their weight.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE

Any unused veterinary medicinal product or waste derived from the use of such products

must be disposed of in accordance with local requirements.

Do not contaminate lakes, watercourses or drains with this product or empty pipettes.

OTHER INFORMATION

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas within 24 hours, ticks and lice within 48 hours of exposure.

Permethrin belongs to the Type I pyrethroid class, which are acaricides and insecticides with repellent activity.

Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.