Issued October 2017
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fiprotec Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
For the full list of excipients, see section 6.1.
Cutaneous Spray, Solution
Clear, colourless liquid
4.1 Target species
Cats and Dogs
4.2 Indications for use, specifying the target species
Treatment and prevention of flea (Ctenocephalides spp.) and tick (Ixodes spp.,
including Ixodes ricinus) infestations in cats and dogs.
Treatment of biting lice infestations in dogs (Trichodectes canis) and cats (Felicola
Insecticidal efficacy against new infestations with adult fleas persists for up to 2
months in cats and up to 3 months in dogs, depending on environmental challenge.
The product has a persistent acaricidal efficacy for up to one month against ticks,
depending on the level of environmental challenge.
Do not use on sick (systemic diseases, fever) or convalescent animals
Do not use in rabbits, as adverse reactions and even death could occur.
Do not use in cases of hypersensitivity to the active substance or to any of the
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Special warnings for each target species
Do not exceed the recommended dosage.
Avoid contact with the animal’s eyes. In the case of accidental eye contact
immediately and thoroughly flush the eyes with water.
Do not spray directly onto areas of broken skin.
Allow treated animals to dry in a well ventilated room (see also section 4.5).
Do not confine animals in an enclosed space or pet carrier until the coat is totally dry.
In the absence of specific tolerance and efficacy data, the product is not
recommended for the treatment of species other than cats and dogs.
For optimum efficacy, it is not recommended to bathe or shampoo animals within the
two day period prior to treatment or within the two day period following treatment.
Bathing or shampooing up to four times in two months has been shown to have no
significant effect on the residual efficacy of the product. Monthly treatment is
recommended when more frequent shampooing is carried out.
For optimal control of flea infestations in multi-pet households, all dogs and cats in
the household should be treated at the same time.
Fleas from pets often infest the animal’s basket, bedding and regular resting areas,
such as carpets and soft furnishings. These should be treated in cases of massive
infestation and upon the initiation of control measures with a suitable insecticide, and
The product is not suitable for direct treatment of the environment.
Given the volume delivered by the spray pump (0.5ml/pump) the product is very
suitable for use in cats and dogs up to 5-10kg bodyweight, depending on the length
of hair (see also section 4.9) but not adequate for medium and large dogs.
Special precautions for use
Special precautions for use in animals
It is important to make sure that animals do not lick each other following treatment.
There may be an attachment of single ticks. For this reason a transmission of
infectious diseases cannot be completely excluded if conditions are unfavourable.
Keep treated animals away from fires or other sources of heat, and surfaces likely to
be affected by the alcohol spray, for at least 30 minutes following spraying and until
the fur is totally dry. Do not spray on a naked flame or any incandescent material.
For external use only.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This product can cause mucous membrane and eye irritation. Therefore, contact of
the product with mouth and eyes should be avoided.
People with asthma or a known hypersensitivity to insecticides or alcohol should
avoid contact with the veterinary medicinal product. Avoid contents coming into
contact with the fingers. If this occurs, wash hands with soap and water. If irritation
occurs, seek medical advice.
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After accidental ocular exposure the eye should be rinsed carefully with plain water.
Treated animals should not be handled until the fur is dry, and children should not be
allowed to play with treated animals until the fur is dry. It is therefore recommended
that animals are not treated during the day, but should be treated during the early
evening, and that recently treated animals are not allowed to sleep with owners,
Spray animals in the open air or a well ventilated room.
Do not breathe spray. Do not smoke, drink or eat during application.
Wear PVC or nitrile gloves during treatment of animals. It is recommended to wear a
waterproof apron for the protection of clothing.
If clothing becomes heavily wetted with the product, it should be removed and
washed before re-use.
Dispose of gloves after use and then wash hands with soap and water.
Treatment of multiple animals: Good ventilation is particularly important where
several animals are to be treated. Treat multiple animals outside, or reduce the build-
up of vapour by removing the animals from the treatment room while the alcohol is
evaporating and ensure that the treatment room is well ventilated between individual
treatments. In addition, ensure that the drying room is well ventilated and avoid
housing several recently treated animals within the same air space.
Fipronil may adversely affect aquatic organisms.
Dogs should not be allowed to swim in watercourses for 2 days after application (see
Adverse reactions (frequency and seriousness)
If licking occurs, a brief period of hypersalivation may be observed due mainly to the
nature of the carrier.
Among the extremely rare suspected adverse reactions, transient cutaneous
reactions erythema, pruritus or alopecia have been reported after use. Exceptionally,
hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous
signs), vomiting or respiratory signs have been observed after use.
Use during pregnancy, lactation or lay
Laboratory studies did not reveal any teratogenic effect of fipronil in the rat and
The formulation is very well tolerated by puppies following treatment of the lactating
Data are not available on treatment of pregnant queens or nursing queens.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with other flea products which are applied directly onto the
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Amounts to be administered and administration route
Route of administration: spray pump for external use.
Method of administration:
Spray the entire body of the animal, and apply from a distance of approximately 10-
Apply against the lay of the hair and make sure that the entire coat of the animal is
dampened. Ruffle the coat, especially in long haired animals, so that the product
penetrates down to the skin.
For treatment of the head region, and when treating young or nervous pets,
application may be carried out by spraying onto a gloved hand and rubbing the
product into the coat. Allow to dry naturally. Do not towel dry.
Posology: It is important to dampen the coat down to the skin. Depending on the
length of hair, apply 3 to 6 ml per kg bodyweight, (7.5 to 15mg of active ingredient
per kg bodyweight) i.e. 6 to 12 pump applications per kg bodyweight of the 100ml
The 100ml bottle contains:
Approximately 3 to 6 treatments for a dog weighing 5 kg, depending on hair length;
Approximately 8 treatments for a short haired cat weighing 4 kg;
Approximately 2 treatments for a long haired dog weighing 8 kg.
Properties : The formulation contains a coating agent. Therefore, spraying builds up
a film and makes the fur glossy.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
Puppies and kittens from 2 days of age may be safely treated.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The risk of experiencing adverse effects (see section 4.6) may increase when
overdosing, so animals should always be treated with the correct dose according to
Start an appropriate symptomatic treatment in case of overdosing.
4.11 Withdrawal period(s)
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides.
ATCvet code: QP53AX15.
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Fipronil is an insecticide and acaricide from the phenylpyrazole family. It acts by
inhibiting the GABA complex, binding to the chloride channel and thereby blocking
pre- and post-synaptic transfer of chloride ions across the membrane. This results in
uncontrolled activity of the central nervous system and death in insects and acarids.
Fipronil exhibits insecticidal and acaricidal activity against fleas (Ctenocephalides
spp.), ticks (Ixodes spp.) and lice (Trichodectes canis and Felicola subrostratus) in
dogs and cats.
The amount of fipronil absorbed by the skin in the dog, after application of the spray
to the coat and skin is extremely slight to negligible.
The persistence of fipronil on the hair is very long (on average 52.5 ± 11.5 days),
given that the limit of quantification of the assay method is 0.25 µg/g.
This can be explained by the fact that fipronil dissolves well in fat and concentrates in
the sebaceous glands. From the sebaceous glands (depot) the amount of fipronil on
the skin is constantly replenished.
In all species fipronil is mainly metabolised to its sulphone derivative (RM1602),
which also possesses insecticidal and acaricidal properties.
The RM1602 detected on the hair after spray application in dogs may be explained
by its presence in the original raw material.
List of excipients
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 1 year.
Special precautions for storage
Do not store above 25
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Nature and composition of immediate packaging
An 100ml bottle consisting of high density polyethylene, fitted with a spray pump
delivering 0.5ml per pump (dip tube consisting of low density polyethylene).
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
Fipronil may adversely affect aquatic organisms. Do not contaminate ponds,
waterways or ditches with the product or empty containers.
MARKETING AUTHORISATION HOLDER
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION
DATE OF REVISION OF THE TEXT
Approved 18 October 2017
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