Frontline Tri-act XL spot on for dogs 40-60 kg - 1 antiparasitic pipette

Liquid antiparasitic solution for cutaneous application packaged in pipettes for a single application.

PACKAGE LEAFLET Cardboard box with 1 pipette

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

DECLARATION OF 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

dog

Careful!!!

Due to the unique physiology of cats which is unable to metabolize certain compounds, including permethrin, this veterinary medicinal product may 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 area where the veterinary medicinal product has been applied to dogs. In the event 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, flies and/or mosquitoes is required.

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

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

was determined by the veterinarian.

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

The product has immediate acaricidal efficacy against the species 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 a 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 removes and kills the dung fly (Stomoxys calcitrans) for five weeks.

CONTRAINDICATIONS

Do not use in sick or convalescent animals.

Do not use in cats and rabbits as it may 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 reactions have been reported after use, at

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

Mild hypersalivation and vomiting may occur in case of product ingestion if the animal licks the area of ​​product application.

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 solution - Unit volume 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 size dog 40-60kg 6 405.6 3028.8 6,750

60 kg Use the appropriate pipette combination

Treatment regimen

The use of the product must be made following confirmation of infestation or risk of infestation with fleas and/or ticks at the same time as the need for repellent activity (anti-feeding) against sandflies and/or mosquitoes and/or flies.

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

RECOMMENDATIONS ON CORRECT ADMINISTRATION

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

Use the necessary combination of pipettes until the appropriate amount 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 spot.

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 peel 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 straight away from your face or body, cut the tip of the pipette with scissors. Make a path through the dog's fur so that the skin is visible. Place the tip of the pipette on the skin.

Squeeze the pipette and apply approximately half of the contents to the mid-section 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 to apply the product directly to the skin and not the fur.

WAITING TIME

Not applicable

SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

Store in original packaging.

Do not store above 25°C.

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

SPECIAL WARNING(S)

Special warnings for each target species

There may already be a single tick attached to the animal or a bite from a mosquito or sandfly. For this reason, the transmission of pathogens by these arthropods cannot be ruled out 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.

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

To reduce reinfestation due to the appearance 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 appropriate for their species.

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

suitable for the environment in which animals live, against fleas and their stages of development.

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 application of the product is made in an area where the animal cannot lick the product and also to ensure that the animals do not lick each other after

treatment.

Due to the unique physiology of cats which is unable to metabolize certain compounds, including permethrin, this veterinary medicinal product may 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 area where the veterinary medicinal product has been applied to dogs. In the event 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 should be avoided.

product with the skin or eyes. 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, it is recommended to immediately

Rinse thoroughly with water. If eye irritation persists, seek medical advice.

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

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

Since the excipient N-methylpyrrolidone may cause fetotoxicity 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 area where the product was applied is dry, and children should not play with the animals until the fur is dry.

Therefore, it is recommended that animals not be treated during the day but in the evening, and that treated animals sleep alone at night, not with their 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 future 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 did not produce any teratogenic or embryotoxic effects. No studies have been conducted with this product in animals during gestation 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 according to the benefit/risk assessment by the veterinarian.

DOSAGE

Safety in use was evaluated in healthy adult dogs treated with up to 5 times the recommended dose.

than the maximum recommended dose (treat 3 times at monthly intervals) and in puppies (8 weeks of age, treat once). Known side effects may include neurological symptoms

mild, vomiting and diarrhea. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette appropriate to 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 the use of such products

must be disposed of in accordance with local requirements.

Do not contaminate lakes, streams or canals 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.

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.

80% for 4 weeks), mosquitoes and ticks.

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Age: Adult

Presentation type: Pipette

Action: Ticks, Fleas, Lice, Flea Larvae, Flies

Dog Weight: 40-60 kg

Pieces Set: 1 piece

Brand Name: Merial

Quantity: 1 Pipette