Frontline Tri act 6 pipettes spot-on solution in dogs
Topical ectoparasiticide
LABORATORY
MERIAL LABORATORIES
PHARMACEUTICAL FORM
Spot-on anointing solution (Sol.udp)
COMPOSITION PER PIPETTE:
• Frontline Tri act 6 pipettes spot on solution for dogs 2 5 kg: Fipronil 33.8 mg; permethrin 252.4 mg; butylated hydroxytoluene (E321) 0.563 mg.
• Frontline Tri act 6 pipettes spot on solution for dogs 5-10 kg: Fipronil 67.6 mg; permethrin 504.8 mg; butylated hydroxytoluene (E321) 1.125 mg.
• Frontline Tri act 6 pipettes spot on solution for dogs 10-20 kg: Fipronil 135.2 mg; permethrin 1009.6 mg; butylated hydroxytoluene (E321) 2,250 mg.
• Frontline Tri act 6 pipettes spot-on solution for dogs 20-40 kg: Fipronil 270.4 mg; permethrin 2019.2mg; butylated hydroxytoluene (E321) 4,500 mg.
• Frontline Tri act 6 pipettes spot-on solution for dogs 40-60 kg: Fipronil 405.6 mg; permethrin 3028.8 mg; butylated hydroxytoluene (E321) 6,750 mg.
• Frontline Tri act 6 pipettes spot on solution for dogs 5-10 kg: Fipronil 67.6 mg; permethrin 504.8 mg; butylated hydroxytoluene (E321) 1.125 mg.
• Frontline Tri act 6 pipettes spot on solution for dogs 10-20 kg: Fipronil 135.2 mg; permethrin 1009.6 mg; butylated hydroxytoluene (E321) 2,250 mg.
• Frontline Tri act 6 pipettes spot-on solution for dogs 20-40 kg: Fipronil 270.4 mg; permethrin 2019.2mg; butylated hydroxytoluene (E321) 4,500 mg.
• Frontline Tri act 6 pipettes spot-on solution for dogs 40-60 kg: Fipronil 405.6 mg; permethrin 3028.8 mg; butylated hydroxytoluene (E321) 6,750 mg.
PHARMACOLOGICAL PROPERTIES
Ectoparasiticide for topical use, combination of fipronil and permethrin.
• Fipronil is an insecticide and acaricide that belongs to the phenylpyrazole family. Fipronil and its metabolite, fipronil sulfone, act by interacting with ligand-gated chloride channels, in particular gamma-aminobutyric acid (GABA) neurotransmitter channels, as well as desensitizing (D) and non-desensitizing (N) channels. glutamate (Glu, the only ligand of chloride channels in invertebrates) blocking the pre- and post-synaptic transfer of chloride ions across cell membranes. As a result, uncontrolled activity of the central nervous system and death of arthropods occurs. Fipronil kills fleas for the first 24 hours and ticks and lice for 48 hours after exposure.
• Permethrin belongs to the class of type I pyrethroids, which are acaricides and insecticides with repellent activity. Pyrethroids affect sodium channels in vertebrates and invertebrates. Pyrethroids are called "open channel blockers" affecting the sodium channel as they slow down both the activation and inactivation properties, leading to a state of hyperexcitation and death of the parasite. In the veterinary medicinal product, permethrin provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.
Ectoparasiticide for topical use, combination of fipronil and permethrin.
• Fipronil is an insecticide and acaricide that belongs to the phenylpyrazole family. Fipronil and its metabolite, fipronil sulfone, act by interacting with ligand-gated chloride channels, in particular gamma-aminobutyric acid (GABA) neurotransmitter channels, as well as desensitizing (D) and non-desensitizing (N) channels. glutamate (Glu, the only ligand of chloride channels in invertebrates) blocking the pre- and post-synaptic transfer of chloride ions across cell membranes. As a result, uncontrolled activity of the central nervous system and death of arthropods occurs. Fipronil kills fleas for the first 24 hours and ticks and lice for 48 hours after exposure.
• Permethrin belongs to the class of type I pyrethroids, which are acaricides and insecticides with repellent activity. Pyrethroids affect sodium channels in vertebrates and invertebrates. Pyrethroids are called "open channel blockers" affecting the sodium channel as they slow down both the activation and inactivation properties, leading to a state of hyperexcitation and death of the parasite. In the veterinary medicinal product, permethrin provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.
INTERACTIONS AND INCOMPATIBILITIES
None known.
INDICATIONS AND TARGET SPECIES
Dogs:
• For the treatment and prevention of infestations by fleas and/or ticks when a repellent activity (anti-feeding) is necessary against sandflies, biting lice and/or mosquitoes.
• For the treatment and prevention of infestations by Ctenocephalides felis fleas and for the prevention of infestations by C tenocephalides canis fleas . C. felis fleas are killed within the first 24 hours after application of the veterinary medicinal product. One treatment prevents further flea infestation for 4 weeks.
• The veterinary medicine can be used as part of the treatment strategy for allergic dermatitis caused by flea bites, when it has been previously diagnosed by a veterinarian.
• The veterinary medicinal product is effective as a repellent against Dermacentor reticulatus ticks from 7 days to 4 weeks after treatment. However, some isolated ticks can attach and detach during the first 24 hours after infestation.
• The veterinary medicinal product is effective as a fast-acting acaricide against Rhipicephalus sanguineus and Ixodes ricinus , but if ticks are present when the veterinary medicinal product is applied, they may not all be killed within 48 hours after treatment.
• The veterinary medicinal product is effective as a persistent acaricide against ticks ( Ixodes ricinus , Dermacentor reticulatus , Rhipicephalus sanguineus ) for 4 weeks.
• The veterinary medicinal product is effective as a repellent (anti-feeding) for 3 weeks against sandflies ( Phlebotomus perniciosus ) and for 4 weeks against mosquitoes ( Culex pipiens ). The veterinary medicinal product is effective as an insecticide with persistent action for 3 weeks against sandflies ( Phlebotomus perniciosus ).
• The veterinary medicine has a repellent effect and kills the stable fly ( Stomoxys calcitrans ) for five weeks.
• For the treatment and prevention of infestations by fleas and/or ticks when a repellent activity (anti-feeding) is necessary against sandflies, biting lice and/or mosquitoes.
• For the treatment and prevention of infestations by Ctenocephalides felis fleas and for the prevention of infestations by C tenocephalides canis fleas . C. felis fleas are killed within the first 24 hours after application of the veterinary medicinal product. One treatment prevents further flea infestation for 4 weeks.
• The veterinary medicine can be used as part of the treatment strategy for allergic dermatitis caused by flea bites, when it has been previously diagnosed by a veterinarian.
• The veterinary medicinal product is effective as a repellent against Dermacentor reticulatus ticks from 7 days to 4 weeks after treatment. However, some isolated ticks can attach and detach during the first 24 hours after infestation.
• The veterinary medicinal product is effective as a fast-acting acaricide against Rhipicephalus sanguineus and Ixodes ricinus , but if ticks are present when the veterinary medicinal product is applied, they may not all be killed within 48 hours after treatment.
• The veterinary medicinal product is effective as a persistent acaricide against ticks ( Ixodes ricinus , Dermacentor reticulatus , Rhipicephalus sanguineus ) for 4 weeks.
• The veterinary medicinal product is effective as a repellent (anti-feeding) for 3 weeks against sandflies ( Phlebotomus perniciosus ) and for 4 weeks against mosquitoes ( Culex pipiens ). The veterinary medicinal product is effective as an insecticide with persistent action for 3 weeks against sandflies ( Phlebotomus perniciosus ).
• The veterinary medicine has a repellent effect and kills the stable fly ( Stomoxys calcitrans ) for five weeks.
CONTRAINDICATIONS
• Do not use in sick or convalescent animals.
• This veterinary medicinal product is for use in dogs only. Do not use in cats or rabbits, as adverse reactions may occur, even resulting in death.
• Do not use in case of hypersensitivity to the active substances or to any of the excipients.
• This veterinary medicinal product is for use in dogs only. Do not use in cats or rabbits, as adverse reactions may occur, even resulting in death.
• Do not use in case of hypersensitivity to the active substances or to any of the excipients.
SIDE EFFECTS
• Transient skin reactions in the area of application (skin discoloration, local hair loss, itching, redness) as well as general itching or hair loss have been observed very rarely after application of the veterinary medicinal product. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, hyperactivity, muscle tremor, depression, other nervous signs) or vomiting have also been observed after use of the veterinary medicinal product.
• In case of licking the area of application, transient hypersalivation and emesis may be observed.
• In case of licking the area of application, transient hypersalivation and emesis may be observed.
ROUTE OF ADMINISTRATION
Topical route. Punctual dorsal anointing.
POSOLOGY
The minimum recommended dose is 6.76 mg fipronil/kg body weight, and 50.48 mg permethrin/kg body weight, equivalent to 0.1 ml spot-on solution per kg body weight.
Dogs (2 to 5 kg): Administer 1 pipette (0.5 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 2 to 5 kg.
Dogs (5 to 10 kg): Administer 1 pipette (1 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 5-10 kg.
Dogs (10 to 20 kg): Administer 1 pipette (2 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 10 to 20 kg.
Dogs (20 to 40 kg): Administer 1 pipette (4 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 20 to 40 kg.
Dogs (40 to 60 kg): Administer 1 pipette (6 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 40 to 60 kg.
Dogs (> 60 kg): Use the appropriate combination of the two pipette sizes that most closely approximate the animal's body weight.
• The use of the veterinary medicinal product should be based on a confirmed infestation or a risk of infestation by fleas and/or ticks where repellent (anti-feeding) activity is also required against sandflies and/or biting mosquitoes and/or lice. Depending on the ectoparasite load in the environment, a repeat treatment may be indicated. In these cases, the interval between two treatments should be at least 4 weeks.
• The veterinary drug should be applied to two points out of the animal's reach so that the animal cannot lick them off. These areas are the base of the neck in front of the shoulder blades and the middle of the neck between the base of the skull and the shoulder blades.
• Remove the blister packs from the cardboard box and separate one blister pack. Remove the pipette by cutting with scissors along the dotted line or by breaking the opening after bending the marked corner. Holding the pipet upright and away from the face and body, cut the tip of the pipet open with scissors. Separate the fur along the dorsal line of the dog until the skin is visible. Place the pipette tip on the skin. Squeeze the pipette, applying approximately half of its contents to the middle of the neck between the base of the skull and the shoulder blades. Repeat the application at the base of the neck in front of the shoulder blades until the pipette is empty. For best results ensure that the veterinary medicinal product is applied directly to the skin and not to the hair.
Dogs (2 to 5 kg): Administer 1 pipette (0.5 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 2 to 5 kg.
Dogs (5 to 10 kg): Administer 1 pipette (1 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 5-10 kg.
Dogs (10 to 20 kg): Administer 1 pipette (2 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 10 to 20 kg.
Dogs (20 to 40 kg): Administer 1 pipette (4 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 20 to 40 kg.
Dogs (40 to 60 kg): Administer 1 pipette (6 ml) of Frontline Tri act 6 pipettes spot-on solution for dogs 40 to 60 kg.
Dogs (> 60 kg): Use the appropriate combination of the two pipette sizes that most closely approximate the animal's body weight.
• The use of the veterinary medicinal product should be based on a confirmed infestation or a risk of infestation by fleas and/or ticks where repellent (anti-feeding) activity is also required against sandflies and/or biting mosquitoes and/or lice. Depending on the ectoparasite load in the environment, a repeat treatment may be indicated. In these cases, the interval between two treatments should be at least 4 weeks.
• The veterinary drug should be applied to two points out of the animal's reach so that the animal cannot lick them off. These areas are the base of the neck in front of the shoulder blades and the middle of the neck between the base of the skull and the shoulder blades.
• Remove the blister packs from the cardboard box and separate one blister pack. Remove the pipette by cutting with scissors along the dotted line or by breaking the opening after bending the marked corner. Holding the pipet upright and away from the face and body, cut the tip of the pipet open with scissors. Separate the fur along the dorsal line of the dog until the skin is visible. Place the pipette tip on the skin. Squeeze the pipette, applying approximately half of its contents to the middle of the neck between the base of the skull and the shoulder blades. Repeat the application at the base of the neck in front of the shoulder blades until the pipette is empty. For best results ensure that the veterinary medicinal product is applied directly to the skin and not to the hair.
SPECIAL PRECAUTIONS
Special precautions for use in animals:
• In the absence of specific studies, the use of the veterinary medicinal product is not recommended in dogs less than 8 weeks of age or in dogs weighing less than 2 kg.
• Avoid contact of the veterinary medicinal product with the dog's eyes.
• It is important to ensure that the veterinary medicinal product is applied to an area where the animal cannot lick it off and that other animals do not lick the area of application after treatment.
• This veterinary medicinal product can induce convulsions in cats which may be fatal, due to the unique physiology of this species, which is unable to metabolize certain compounds, including permethrin. In case of accidental dermal exposure, wash the cat with shampoo or soap, and consult a veterinarian immediately.
• To avoid accidental exposure of cats to the veterinary medicinal product, they should be kept away from treated dogs until the application site is dry. It is important to ensure that cats do not lick the area of application of the veterinary medicinal product on a treated dog. In case of exposure of this type, consult the veterinarian immediately.
Use during pregnancy and lactation:
• Laboratory studies using fipronil or permethrin have not shown teratogenic or embryotoxic effects. No studies have been performed with this veterinary medicinal product in pregnant or lactating animals.
• N-methylpyrrolidone, the excipient of the veterinary drug, has been shown to be teratogenic in laboratory animals after repeated exposure at high doses.
• Use only according to the benefit / risk assessment carried out by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
• This veterinary medicinal product can cause eye and skin irritation, therefore contact with the skin and eyes should be avoided. Do not open the pipette near or in the direction of the face. In case of eye exposure or eye irritation during administration, immediately rinse eyes with plenty of water. If eye irritation persists, consult a physician. In case of dermal exposure or skin irritation during administration, immediately wash skin with plenty of soap and water. If skin irritation persists or recurs, consult a physician.
• People with known hypersensitivity to fipronil and/or permethrin should avoid all contact with the veterinary medicinal product.
• The veterinary medicinal product is harmful if swallowed. Avoid contact of hands with mouth. Do not smoke, drink or eat during the application. Wash hands after use. In case of accidental ingestion, rinse your mouth and consult a doctor if you feel unwell.
• Since the excipient N-methylpyrrolidone can induce foetotoxicity and teratogenicity after significant exposure, pregnant women should wear gloves to avoid contact with the veterinary medicinal product.
• Treated animals should not be touched until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. Therefore it is recommended not to treat the animals during the day, but in the evening, and that recently treated animals do not sleep with the owners, especially children.
• The pipettes must be kept in the original blister pack and once used, the empty pipettes must be disposed of immediately in an appropriate way, preventing access to them.
• In the absence of specific studies, the use of the veterinary medicinal product is not recommended in dogs less than 8 weeks of age or in dogs weighing less than 2 kg.
• Avoid contact of the veterinary medicinal product with the dog's eyes.
• It is important to ensure that the veterinary medicinal product is applied to an area where the animal cannot lick it off and that other animals do not lick the area of application after treatment.
• This veterinary medicinal product can induce convulsions in cats which may be fatal, due to the unique physiology of this species, which is unable to metabolize certain compounds, including permethrin. In case of accidental dermal exposure, wash the cat with shampoo or soap, and consult a veterinarian immediately.
• To avoid accidental exposure of cats to the veterinary medicinal product, they should be kept away from treated dogs until the application site is dry. It is important to ensure that cats do not lick the area of application of the veterinary medicinal product on a treated dog. In case of exposure of this type, consult the veterinarian immediately.
Use during pregnancy and lactation:
• Laboratory studies using fipronil or permethrin have not shown teratogenic or embryotoxic effects. No studies have been performed with this veterinary medicinal product in pregnant or lactating animals.
• N-methylpyrrolidone, the excipient of the veterinary drug, has been shown to be teratogenic in laboratory animals after repeated exposure at high doses.
• Use only according to the benefit / risk assessment carried out by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
• This veterinary medicinal product can cause eye and skin irritation, therefore contact with the skin and eyes should be avoided. Do not open the pipette near or in the direction of the face. In case of eye exposure or eye irritation during administration, immediately rinse eyes with plenty of water. If eye irritation persists, consult a physician. In case of dermal exposure or skin irritation during administration, immediately wash skin with plenty of soap and water. If skin irritation persists or recurs, consult a physician.
• People with known hypersensitivity to fipronil and/or permethrin should avoid all contact with the veterinary medicinal product.
• The veterinary medicinal product is harmful if swallowed. Avoid contact of hands with mouth. Do not smoke, drink or eat during the application. Wash hands after use. In case of accidental ingestion, rinse your mouth and consult a doctor if you feel unwell.
• Since the excipient N-methylpyrrolidone can induce foetotoxicity and teratogenicity after significant exposure, pregnant women should wear gloves to avoid contact with the veterinary medicinal product.
• Treated animals should not be touched until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. Therefore it is recommended not to treat the animals during the day, but in the evening, and that recently treated animals do not sleep with the owners, especially children.
• The pipettes must be kept in the original blister pack and once used, the empty pipettes must be disposed of immediately in an appropriate way, preventing access to them.
WAIT TIME
Not applicable.
PRESERVATION MODE
Store in the original blister pack. Do not store at temperatures above 25 °C.
OBSERVATIONS
Medicine not subject to veterinary prescription.
PRESENTATION
• Frontline Tri Act spot on solution for dogs 2 5 kg: Plastic blister card with 1 pipette containing 0.5 ml. Cardboard box with 3 or 6 pipettes containing 0.5 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 5 10 kg: Plastic blister card with 1 pipette containing 1 ml. Cardboard box with 3 or 6 pipettes containing 1 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 10 20 kg: Plastic blister card with 1 pipette containing 2 ml. Cardboard box with 3 or 6 pipettes containing 2 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 20 40 kg: Plastic blister card with 1 pipette containing 4 ml. Cardboard box with 3 or 6 pipettes containing 4 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 40 60 kg: Plastic blister card with 1 pipette containing 6 ml. Cardboard box with 3 or 6 pipettes containing 6 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 5 10 kg: Plastic blister card with 1 pipette containing 1 ml. Cardboard box with 3 or 6 pipettes containing 1 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 10 20 kg: Plastic blister card with 1 pipette containing 2 ml. Cardboard box with 3 or 6 pipettes containing 2 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 20 40 kg: Plastic blister card with 1 pipette containing 4 ml. Cardboard box with 3 or 6 pipettes containing 4 ml each.
• Frontline Tri act 6 pipettes spot on solution for dogs 40 60 kg: Plastic blister card with 1 pipette containing 6 ml. Cardboard box with 3 or 6 pipettes containing 6 ml each.
REG. No.
Frontline Tri Act spot on solution for dogs 2 5 kg: 3089 ESP
Frontline Tri Act spot on solution for dogs 5 to 10 kg: 3090 ESP
Frontline Tri Act spot on solution for dogs 10-20 kg: 3091 ESP
Frontline Tri Act spot on solution for dogs 20-40 kg: 3092 ESP
Frontline Tri Act spot on solution for dogs 40-60 kg: 3093 ESP
Frontline Tri Act spot on solution for dogs 5 to 10 kg: 3090 ESP
Frontline Tri Act spot on solution for dogs 10-20 kg: 3091 ESP
Frontline Tri Act spot on solution for dogs 20-40 kg: 3092 ESP
Frontline Tri Act spot on solution for dogs 40-60 kg: 3093 ESP