Effipro*Fl Spray 250Ml2.5Mg/Ml

EFFIPRO SPRAY
NAME OF THE VETERINARY MEDICINAL PRODUCT
EFFIPRO 2.5 mg/ml topical spray solution, for dogs and cats
Fipronil
ACTIVE INGREDIENTS AND OTHER SUBSTANCES
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
INTENDED 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 biting lice in dogs (Trichodectes canis) and cats (Felicola
subrostratus).
The product can be used as part of a strategic treatment to control flea allergic dermatitis (FAD).
The insecticidal efficacy against new adult flea infections lasts up to 2 months in cats and up to 3
months in dogs, depending on environmental infestation severity.
The product has a persistent acaricidal effect for up to 4 weeks against ticks, depending on the
level of environmental infestation.
COUNTERINDICATIONS
Do not use on sick animals (systemic diseases, fever…) or convalescent animals.
Do not use on rabbits, as adverse reactions and even death may occur.
Do not use if hypersensitive to the active ingredient or any excipients.
ADVERSE REACTIONS
In case of licking, a brief period of hypersalivation may occur mainly due to the
nature of the excipients.
Among extremely rare suspected adverse reactions, transient skin reactions such as itching and alopecia at the application site have been reported after use. Rarely, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms)
vomiting or respiratory symptoms have been reported after use.
If serious adverse reactions or other reactions not mentioned in this leaflet occur, please inform the veterinarian.
METHOD AND ROUTE OF ADMINISTRATION

Method of administration:
Mechanical pump spray for external use only.
The pump delivers 0.5 ml (bottle of 100 ml).
The pump delivers 1.5 ml (bottle of 250 ml).
The pump delivers 3 ml (bottle of 500 ml).
Dosage
To wet the coat down 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 hair length.
This dose can be achieved with 6-12 sprays per application per kg of live weight from the 100 ml
package.
This dose can be achieved with 2-4 sprays per application per kg of live weight from the 250 ml
package.
This dose can be achieved with 1-2 sprays per application per kg of live weight from the 500 ml
package.
Depending on hair length, the 100 ml pack allows 4-8 treatments for a 4 kg cat or 3 treatments for a 10 kg dog.
Depending on hair length, the 250 ml pack allows 2-4 treatments for a 20 kg dog.
Depending on hair length, the 500 ml pack allows 2-4 treatments for a 40 kg dog.
Method of administration
Spray over the entire body surface of the animal from a distance of 10-20 cm. Spray against the
direction of hair growth and ensure the entire body surface is evenly wetted. Frizz the
hair, especially in long-haired animals, to bring the product into direct contact with the skin.
For treating the head or young or nervous animals, application can be made using a glove and passing
it against the hair. Allow to dry naturally. Do not dry with towels.
Properties
The formulation contains a fixing agent. Therefore, spraying creates a film that makes the hair
shine.
IMPORTANT FOR CORRECT APPLICATION
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 old can be safely treated.
WITHHOLDING PERIOD
Not applicable.
SPECIAL PRECAUTIONS, IF NECESSARY
Read the package leaflet before use.
Special warnings for each intended species.
Do not exceed the recommended doses.
Avoid direct contact with the animal’s eyes.
Do not spray directly on areas with lesions.
Allow treated animals to dry in a well-ventilated room beforehand (see also
“Special precautions for use in animals”).
Do not confine animals in closed spaces or in cages until the coat is completely dry.
In the absence of specific safety and efficacy data, the product is not recommended for use on species other than dogs and cats.
When used as part of a strategic program for flea allergic dermatitis, monthly application is recommended for allergic patients and other dogs and cats in the group.
For optimal effectiveness, bathing or shampooing animals 2 days before or after application is not recommended. 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 kennels, beds, carpets, and cushions with appropriate insecticides will help reduce 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.
Precautions for use in animals
It is important to ensure that animals do not lick each other after treatment.
There may be tick attacks. For this reason, transmission of infectious diseases cannot be completely ruled out if conditions are unfavorable.
The product is not suitable for direct environment treatment.
Keep treated animals away from fire or heat sources and surfaces that could be damaged by spray alcohol, 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 mucous membranes and eyes. Therefore, avoid contact of the product with the mouth or eyes.
Animals and operators with known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contact of the contents with fingers. If this happens, wash hands with soap and water.
In case of accidental contact with eyes, rinse immediately and thoroughly with water.
Treated animals should not be touched until the coat is dry; children should not play with treated animals until the coat is dry. It is recommended that animals are not treated during the day, but they can be treated in the early evening, and animals just treated should not sleep with owners or especially children.
Spray onto animals in an open place or in a well-ventilated room.
Do not breathe in the spray. Do not eat, drink, or smoke during product use.

Wear rubber or PVC gloves during treatment of animals. It is recommended to wear a waterproof apron to protect clothing. If clothes become heavily contaminated with the product, they should be removed and washed before reuse.
Remove gloves after use and wash hands with soap and water.
Immediately wash contaminated skin with water and soap. Seek medical advice if irritation occurs. Persons with known hypersensitivity or asthma may be particularly sensitive to the product.
Do not use the product if you have previously reacted to it.
Treating groups of animals: Good ventilation is particularly important in environments where a group of animals is being treated. Treat animals outdoors, or reduce vapor saturation by moving animals away from the treatment area while alcohol evaporates and ensure the room is well ventilated between individual treatments. Also, ensure that the place where animals are left to dry is well ventilated and avoid housing recently treated animals in the same space.
Other precautions
Fipronil is toxic to aquatic organisms. Do not allow dogs to immerse in watercourses for 2 days after application.
Use during pregnancy, lactation, or oocyte deposition
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, so use only in accordance with the veterinarian’s risk/benefit assessment.
Overdose
The risk of adverse reactions may increase in case of overdose.
In case of overdose, initiate symptomatic treatment.
IMPORTANT STORAGE PRECAUTIONS
Highly flammable. Do not store above 25°C. Protect from direct sunlight.
Do not use after the expiry date marked on the bottle.
Shelf life after first opening: 1 year.
After first use, consume by:……..
SPECIAL PRECAUTIONS, IF NECESSARY, 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 regulations and delivered 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 STATEMENT “FOR ANIMAL USE ONLY” AND CONDITIONS OR LIMITATIONS
RELATING TO SUPPLY AND USE, IF APPLICABLE
For animal use only.
Sale is not reserved exclusively for pharmacies and is not subject to a veterinary prescription.
17. THE STATEMENT “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of reach and sight of children.
NAME AND ADDRESS OF THE HOLDER OF THE MARKETING AUTHORIZATION
AND THE MANUFACTURER RESPONSIBLE FOR LOT 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 No. 104058019 Bottle of 100 ml
AIC No. 104058021 Bottle of 250 ml
AIC No. 104058033 Bottle of 500 ml
BATCH NUMBER
Batch: {number}
DATE OF THE LAST REVISION OF THE LEAFLET
May 2009
OTHER INFORMATION
Pack sizes: 100 ml, 250 ml, 500 ml.
It is possible that not all packages are commercially available