STATEMENT OF ACTIVE SUBSTANCES AND OTHER SUBSTANCES

Active principle:
Fipronil 2.5 mg / ml

PHARMACEUTICAL FORM
Spray solution for topical use

TARGET SPECIES
Dogs and cats

INDICATIONS
For the treatment of flea infestations (Ctenocephalides spp.) In dogs and cats.
For the treatment of tick infestations (Ixodes ricinus, Rhipicephalus sanguineus) in dogs and cats.
For the treatment of dog lice (Trichodectes canis) and cat lice (Felicola subrostratus).
The product can be used as part of the strategic treatment for the control of flea allergy dermatitis (FAD).
The insecticidal efficacy against new adult flea infections persists for up to 6 weeks in cats and up to 3 months in dogs, depending on the severity of the environmental infestation.
The product has a persistent acaricidal efficacy for up to 4 weeks against ticks, in relation to the level of environmental infestation.

CONTRAINDICATIONS
Do not use on sick animals (systemic diseases, fever ...) or convalescing.
Do not use on rabbits, as adverse reactions and even death can occur.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS
In case of licking, a short period of hypersalivation may be observed mainly due to the nature of the excipients.

Among the extremely rare suspected adverse reactions, after use, transient skin reactions at the application site such as pruritus and alopecia have been reported. After use, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have been exceptionally reported.

If serious adverse reactions or other reactions not mentioned in this leaflet occur, please inform your veterinarian.

METHOD AND ROUTE OF ADMINISTRATION
Route of administration:
Spray with mechanical pump for external use only.
The pump delivers 0.5ml (100ml bottle).
The pump delivers 1.5ml (250ml bottle).
The pump delivers 3ml (500ml bottle).

Dosage
In order to wet the hair up to the skin, apply 3 or 6 ml per kg of live weight (from 7.5 to 15 mg of active ingredient per kg of live weight), depending on the length of the hair.
This dosage can be achieved with 6-12 puffs per application per kg of live weight of the 100 ml pack.
This dosage can be achieved with 2-4 pumps per application per kg of live weight of the 250 ml pack.
This dosage can be achieved with 1-2 pumps per application per kg of live weight of the 500 ml pack.

Depending on the length of the hair, the 100 ml pack allows 4-8 treatments for a 4 kg live weight cat or 3 treatments for a 10 kg dog.
Depending on the length of the hair, the 250 ml pack allows 2-4 treatments for a 20 kg dog.
Depending on the length of the hair, the 500 ml pack allows 2-4 treatments for a 40 kg dog.

Method of administration
Spray over the entire surface of the animal's body from a distance of 10-20 cm. Spray against the grain and make sure that the entire body surface is evenly wet. Rub the hair especially in animals with long hair to bring the product into direct contact with the skin. For the treatment of the head or of young or nervous animals, the application can be made on a glove to then pass it against the hair on the hair. Leave to dry naturally. Do not dry with towels.

Property

The formulation contains a fixing agent. Then the mist creates a film that makes the hair shiny.

WARNING FOR CORRECT ADMNISTRATION

Treatment program
For optimal control of flea and / or tick infestations the treatment program can be based on the local epidemiological situation.
In the absence of safety studies, the minimum interval between treatments is 4 weeks.
Puppies and kittens from 2 days of age can be treated safely.

WAITING TIME
Not relevant.

IF NECESSARY, SPECIAL WARNINGS
Read the package leaflet before use.
Special warnings for each target species.

Do not exceed the recommended dose.
Avoid direct contact with the animal's eyes.
Do not spray directly on areas with broken skin.
Allow treated animals to dry in a well-ventilated room first (see also "Special precautions for use in animals")
Do not lock pets indoors or in pet carriers until the skin is completely dry.
In the absence of specific data on safety and efficacy, the product is not recommended for the treatment of other species apart from dogs and cats.
When used as part of a strategic program for the treatment of Flea Allergic Dermatitis, monthly application is recommended to allergic patients and other dogs and cats in the group.
For optimal effectiveness, it is not recommended to bathe or shampoo animals in the 2 days before or after applying the product.
Baths or shampoos up to 4 times in two months showed no significant effect on the residual efficacy of the product. Monthly treatments are recommended when using more frequent shampoos.
Treatments of kennels, beds, carpets and pillows with appropriate insecticides will help in the reduction of environmental infestation and improve the duration of the protection against re-infestation.
For optimal control of flea infestation in the presence of promiscuous groups of animals, all dogs and cats in the family / group should be treated with an appropriate insecticide.

Special precautions for use in animals
It is important to ensure that animals do not lick each other after treatment.
There may be tick attack. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are unfavorable.
The product is not suitable for direct treatment of the environment.
Keep treated animals away from fire or heat sources and surfaces that could be damaged by alcohol in the spray, for at least 30 minutes after treatment and until the coat is completely dry.

Special precautions to be taken by the person administering the product to animals.
The product can cause irritation to the mucous membranes and eyes. Therefore, contact of the product with the mouth or eyes should be avoided.
Animals and operators with known hypersensitivity to insecticide or alcohol must avoid contact with the product.
Avoid the content coming into contact with your fingers. If this happens, wash your hands with soap and water.
In case of accidental contact with the eyes, wash the eyes immediately and abundantly with water.

Treated animals should not be touched until the hair has dried, children should not be allowed to play with treated animals until the hair has dried.
It is therefore recommended that animals are not treated during the day, but could be treated in the early evening, newly treated animals should not sleep with their owners and in particular with children.

Spray on animals in an open place or in a well-ventilated room.
Do not breathe in the spray. Do not eat, drink or smoke while using the product.

Wear rubber or PVC gloves when handling animals.
It is recommended to wear a waterproof apron for clothing protection.
If clothing gets very wet with the product, it should be removed and washed before putting it back on.
Remove gloves after use and wash hands with soap and water.

Wash contaminated skin immediately with soap and water.
If irritation occurs, seek medical attention.
People with known hypersensitivity or asthma may be particularly sensitive to the product.
Do not use the product if you have had a previous reaction to the product.

Treatment of groups of animals: Good ventilation is particularly important in environments where a group of animals is to be treated.
Treat animals outside, or reduce vapor saturation by moving animals away from the treatment site as the alcohol evaporates and ensure the room is well ventilated between individual treatments.
Also, make sure that the place where animals are left to dry is well ventilated and avoid housing multiple recently treated animals in the same space.

Other precautions
Fipronil is toxic to aquatic organisms.
Dogs should not be allowed to soak in streams of water for 2 days after application.

Use during pregnancy or lactation
Laboratory studies using fipronil have shown no evidence of teratogenic effects in rats and rabbits.
Fipronil is well tolerated by puppies following treatment of lactating bitches.
There are no data available on the safety of the product on pregnant or lactating bitches or cats.
The safety of the veterinary medicinal product has not been established, therefore use only according to the benefit / risk assessment by the responsible veterinarian.

Overdose
The risk of adverse reactions may increase in the event of an overdose.
In case of overdose, initiate symptomatic treatment.

STORAGE
Highly flammable.
Do not store above 25 ° C. Protect from direct sunlight.
Do not use after the expiry date stated on the bottle.
Shelf life after first opening the container: 1 year.
After first use, consume by: .........

PRECAUTIONS FOR DISPOSAL OF MEDICINAL PRODUCTS NOT USEDATIOR WASTE
All unused veterinary medicinal products or waste derived from such medicinal products must be disposed of in accordance with local laws and disposed of in the appropriate collection and disposal systems for unused or expired medicinal products.
Fipronil is toxic to aquatic organisms.
Do not contaminate puddles, waterways or ditches with product or empty container.

For veterinary use only.
The sale is not reserved exclusively for pharmacies and is not subject to a medical-veterinary prescription