Effipro*Fl Spray 500Ml2,5Mg/Ml

EFFIPRO SPRAY
VETERINARY MEDICINAL PRODUCT NAME
EFFIPRO 2.5 mg/ml spray solution for topical use, for dogs and cats
Fipronil
ACTIVE INGREDIENTS AND OTHER SUBSTANCES INDICATION
Active ingredient:
Fipronil 2.5 mg/ml
PHARMACEUTICAL FORM
Topical spray solution
PACKAGING
Bottle of 100 ml
Bottle of 250 ml
Bottle of 500 ml
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 biting lice (Trichodectes canis) and cat lice (Felicola
subrostratus).
The product may be used as part of the strategic treatment for controlling flea allergy
dermatitis (FAD).
The insecticidal efficacy against new infestations of adult fleas lasts up to 2 months in cats and up to 3
months in dogs, depending on the severity of environmental infestation.
The product has persistent acaricidal efficacy for up to 4 weeks against ticks, depending on the
level of environmental infestation.
CONTRAINDICATIONS
Do not use on sick animals (systemic diseases, fever…) or recovering animals.
Do not use on rabbits, as adverse reactions and even death may occur.
Do not use in case of hypersensitivity to the active ingredient or 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, transient skin reactions at the application site
such as itching and alopecia have been reported after use. After use, hypersalivation, reversible
neurological symptoms (hyperesthesia, depression, nervous symptoms), vomiting, or respiratory symptoms
have been exceptionally reported.
If severe adverse reactions or other reactions not mentioned in this leaflet occur, please inform the
veterinarian.
ADMINISTRATION ROUTE AND METHOD OF ADMINISTRATION

Route of administration:
Spray with mechanical pump for external use only.
The pump delivers 0.5 ml (100 ml bottle).
The pump delivers 1.5 ml (250 ml bottle).
The pump delivers 3 ml (500 ml bottle).
Dosage
To wet the hair down to the skin, apply 3 or 6 ml per kg of body weight, (from 7.5 to 15 mg of
active ingredient per kg of body weight), depending on the length of the hair.
This dosage can be achieved with 6-12 sprays per application per kg of body weight of the
100 ml package.
This dosage can be achieved with 2-4 sprays per application per kg of body weight of the
250 ml package.
This dosage can be achieved with 1-2 sprays per application per kg of body weight of the
500 ml package.
Depending on the length of the hair, the 100 ml package allows for 4-8 treatments for a 4 kg cat
or 3 treatments for a 10 kg dog.
Depending on the length of the hair, the 250 ml package allows for 2-4 treatments for a 20 kg dog.
Depending on the length of the hair, the 500 ml package allows for 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 hair and ensure that the entire body surface is uniformly wet. Rub the
hair especially in animals with long hair to ensure the product makes direct contact with the skin.
For treatment of the head or young or nervous animals, application can be done on a
glove and rubbed against the hair. Allow to dry naturally. Do not towel dry.
Properties
The formulation contains a fixing agent. Thus, the spray creates a film that makes the hair
shiny.
WARNING FOR PROPER ADMINISTRATION
Treatment program
For optimal control of flea and tick infestations, the treatment program can be
based on 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.
WITHHOLDING TIME
Not applicable.
IF NECESSARY, SPECIAL WARNINGS
Read the leaflet before use.
Special warnings for each target species.
Do not exceed the recommended doses.
Avoid direct contact with the animal's eyes.
Do not spray directly onto areas with damaged skin.
Allow treated animals to dry in a well-ventilated room before (see also
“Special precautions for use in animals”)
Do not confine treated animals in closed spaces or animal carriers until their skin is
completely dry.
In the absence of specific safety and efficacy data, 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 to allergic patients and other dogs and cats in the group is recommended.
For optimal efficacy, bathing or shampooing of animals is not recommended 2 days before or
after the application of the product. Baths or shampoos up to 4 times in two months have not shown
significant effects on the residual efficacy of the product. Monthly treatments are recommended when
more frequent shampoos are performed.
Treatments of beds, bedding, carpets, and cushions with appropriate insecticides will help in reducing the
environmental infestation and improve the duration of protection against re-infestation.
For optimal control of flea infestations in the presence of promiscuous groups of animals, all
dogs and cats in the family/group must 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 a tick attack. For this reason, the transmission of infectious diseases cannot be
completely excluded if conditions are unfavorable.
The product is not suitable for the direct treatment of the environment.
Keep treated animals away from fire or heat sources and surfaces that could be
damaged by the alcohol in the spray, for at least 30 minutes after treatment and until the hair is
completely dry.
Special precautions to be taken by the person administering the product to
animals
The product may cause irritation to mucous membranes and eyes. Therefore, contact of the
product with the mouth or eyes should be avoided.
Animals and operators with known hypersensitivity to the insecticide or alcohol should avoid contact
with the product. Avoid the contents coming into contact with fingers. In case it happens, wash hands
with water and soap.
In case of accidental contact with eyes, rinse eyes immediately and thoroughly
with water.
Treated animals must not be touched until their hair has dried; children must not be allowed to play with treated animals until their hair has dried. It is therefore recommended that animals be treated during the night, but they could be treated in the early evening; animals just treated must not sleep with owners and especially with children.
Spray animals in an open place or in a well-ventilated room.
Do not breathe in the spray. Do not eat, drink, or smoke during the use of the product.

Wear rubber or PVC gloves while treating the animals. It is recommended to wear a
waterproof apron to protect clothing. If clothing becomes heavily soaked with the
product, it should be removed and washed before re-wearing.
Dispose of gloves after use and wash hands with water and soap.
Wash contaminated skin immediately with water and soap. In case of irritation consult a
doctor. Persons with known hypersensitivity or asthma may be particularly sensitive to the product.
Do not use the product if a previous reaction to the product has occurred.
Treatment of groups of animals: Good ventilation is particularly important in environments
where a group of animals is to be treated. Treat the animals outdoors, or reduce steam saturation by moving
the animals from the treatment area while the alcohol evaporates and make sure the
room is well ventilated between individual treatments. Also, ensure that the place where the animals are left
to dry is well ventilated and avoid housing more recently treated animals in the same space.
Other precautions
Fipronil is toxic to aquatic organisms. Dogs should not be allowed to immerse in watercourses for 2 days after application.
Use during pregnancy, lactation, or laying eggs
Laboratory studies using fipronil have not shown any evidence of teratogenic effects in
rats and rabbits. Fipronil is well tolerated by puppies following the treatment of lactating female dogs.
There are no data available on the safety of the product in pregnant or lactating female dogs or queens. The
safety of the veterinary medicine has not been established, therefore use only according to the
risk-benefit assessment of the responsible veterinarian.
Overdose
The risk of adverse reactions may increase in case of overdose.
In case of overdose, initiate symptomatic treatment.
PARTICULAR PRECAUTIONS FOR 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 of the container: 1 year.
After the first use, consume within:……..
IF NECESSARY, SPECIAL PRECAUTIONS TO BE TAKEN FOR THE
DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE
All unused veterinary medicines or waste derived from such medicines must be disposed of in
accordance with local legal provisions and handed over to appropriate collection and disposal systems for
unused or expired medicines.
Fipronil is toxic to aquatic organisms. Do not contaminate ponds, watercourses, or ditches with the
product or empty container.
THE WRITING “FOR VETERINARY USE ONLY” AND CONDITIONS OR LIMITATIONS
RELATED TO SUPPLY AND USE, IF RELEVANT
For veterinary use only.
The sale is not exclusively restricted to pharmacies and is not subject to veterinary prescription.
17. THE WRITING “KEEP OUT OF REACH OF CHILDREN”
Keep out of reach and sight of children.
NAME AND ADDRESS OF THE HOLDER OF THE MARKETING AUTHORIZATION
AND RESPONSIBLE MANUFACTURER OF BATCH RELEASE
Virbac S.A.
1
ère avenue – 2065 m – L.I.D.
06516 Carros
FRANCE
+ 33 (0)4 92 08 73 04
+ 33 (0)4 92 08 73 48
Sales representative in Italy: VIRBAC S.r.l - via Caldera, 21 - 20153 Milan.
MARKETING AUTHORIZATION NUMBER
AIC N° 104058019 Bottle of 100 ml
AIC N° 104058021 Bottle of 250 ml
AIC N° 104058033 Bottle of 500 ml
MANUFACTURING BATCH NUMBER
Batch: {number}
DATE OF LAST REVIEW OF THE LEAFLET
May 2009
OTHER INFORMATION
Packaging: 100 ml, 250 ml, 500 ml.
It is possible that not all packages are marketed