Effinol spray 2,5mg 500ml treatment and prevention of fleas and ticks

EFFINOL 2,5 mg/ml solution for skin spray for dogs and cats.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Fipronil …………………………………………………………2,5mg
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Skin spray solution
Clear, colorless to slightly yellow solution,
4. CLINICAL DATA
4.1 Target species
Dogs and cats
4.2 Indications for use, specifying the target species
Treatment and prevention of infestation by fleas (Ctenocephalides spp.) and ticks
(Ixodes ricinus, Rhipicephalus sanguineus) in dogs.
Treatment and prevention of infestation by fleas (Ctenocephalides spp.) and ticks
(Rhipicephalus spp.., Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis) in cats.
The veterinary drug can be used as part of a treatment strategy for the
control of dermatitis due to allergy to flea bites (DAPP).
Treatment of Lice Infestations in Dogs (Canis Trichodectes) and cats (Felicola
substratus).
4.3 Contraindications
Do not administer to sick animals (systemic diseases, fever...) or convalescents.
Do not administer to rabbits, as adverse drug reactions may occur.
vet and even death.
Do not use in case of hypersensitivity to the active substance or to alcohol.
4.4 Special warnings for each target species
Avoid contact with the eyes of animals
Do not exceed the recommended dose.
Do not spray directly on damaged areas of the skin
Allow treated animals to dry in a well-ventilated room (see section 4.5
ii)
It is not recommended to bathe or soap animals during the 2 days before or after the
treatment with the veterinary medicinal product.
4.5 Special precautions for use
Special precautions for use in animals
It is important to ensure that the animals do not lick each other after feeding.
treatment.
A tick may remain attached. For this reason, it cannot be completely excluded.
transmission of infectious diseases if conditions are unfavorable.
Special precautions to be taken by the person administering the medicinal product
vet to animals
This veterinary medicinal product can cause irritation to the mucous membranes and the
eyes. Therefore, contact of the veterinary medicinal product with the mouth and
eyes.
People with known hypersensitivity to insecticides or alcohol should avoid all
contact with the veterinary medicinal product.
Avoid getting the veterinary medicinal product on your fingers. If this occurs,
wash your hands with soap and water.
After accidental eye exposure, the eyes should be washed carefully with plenty of
Water.
Spray the veterinary medicinal product to the animals in the open air or in a properly
ventilated.
Wear PVC or nitrile gloves during treatment of animals.
Treated animals should not be handled until the skin is dry, and should not be allowed to
Allow children to play with such treated animals until the skin is dry. By
Therefore, it is recommended to avoid treating animals during the day, and to treat them
preferably at dusk, also ensuring that recently treated animals do not
sleep with the owners, particularly with the children.
Do not smoke, drink or eat during the application. Wash hands after use.
Other precautions
Fipronil is toxic to aquatic organisms. Treated dogs should not be bathed in
streams for two days after application to avoid adverse effects
in aquatic organisms.
4.6 Adverse reactions (frequency and seriousness)
If the animal licks itself, a brief period of hypersalivation may be observed due to
mainly to the nature of the excipient.
Among the extremely rare suspected adverse reactions, reactions were described
transient skin rashes such as erythema, pruritus or alopecia after use. in cases
exceptionally, hypersalivation, reversible neurological signs (hyperesthesia,
depression, nervous signs), vomiting, or respiratory signs after use.
Do not overdose.
4.7 Use during pregnancy, lactation or lay
Laboratory studies carried out in rats and rabbits have not shown any effect
teratogenic of fipronil. It can be used during pregnancy.
After the treatment of lactating bitches, it was verified that the puppies tolerate the
fipronil. It can be used during lactation.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
lactation in cats Use only according to benefit/risk assessment
by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Cutaneous use
Shot
To wet the coat down to the skin, apply 3 to 6 ml per kg of body weight (7,5 to 15 mg
of active substance per kg body weight), depending on hair length: 3 ml/kg body weight
for short-haired animals up to 6 ml/kg body weight for long-haired animals.
The dose can be achieved with 6 to 12 sprays per kg of body weight of the format of
100 ml, or with 2 to 4 sprays of the 250 ml or 500 ml format.
As part of the treatment strategy to control allergy dermatitis,
recommends a monthly application to allergic animals and to all animals that live
together with him.
The veterinary medicinal product is active for up to 2 months against fleas. It is effective against
tick infestations up to 1 month. In the case of lice, if necessary, repeat the
treatment after 4 weeks of the first application.
In the absence of safety studies, the minimum interval between treatments is 4 weeks.
Administration mode
Spray the veterinary medicinal product over the entire body of the animal and apply it to a
distance of about 10-20 cm. Apply against the direction of hair growth
and make sure the entire coat is wet. Separate the fur, in particular
in animals with a lot of hair, in order to allow the veterinary medicinal product to penetrate into the
fur. Let it dry naturally. Do not dry it with a towel.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The risk of adverse reactions may increase in cases of overdose, so
Animals must always be treated with the correct dose according to body weight.
In case of overdose, appropriate symptomatic treatment should be initiated.
4.11 Waiting time(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use. Fipronil
ATCvet code: QP53AX15
5.1 Pharmacodynamic properties
Fipronil is an insecticide and acaricide of the phenylpyrazole family. It works by inhibiting
GABA complex, binding to the chlorine channel and thus blocking the transfer pre and
postsynaptic release of chloride ions across cell membranes. This generates a
uncontrolled activity of the central nervous system and the death of insects and mites.
Fipronil shows insecticidal and acaricidal activity against fleas (Ctenocephalides spp)
in dogs and cats and lice (Trichodectes canis) in dogs and (Felicola subrustratus) in cats.
Fipronil also has an acaricidal activity against ticks (Rhipicephalus spp..,
Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis) in the cat and in the dog.
5.2 Pharmacokinetic data
Absorption
The amount of fipronil absorbed through the skin in the dog, after application of the spray to the coat and
the skin is very small and even tiny.
Distribution
The persistence of fipronil in the hair is very long (on average 52,5 ± 11,5 days), since the
limit of quantification of the titration method is 0,25 μg/g.
biotransformation
In all species, fipronil is mainly metabolized to its sulfone derivative.
(RM1602), which also has insecticidal and acaricidal properties.
The RM1602 detected in the hair after spraying the dog can be explained by the
presence of the derivative in the original raw material.

6. PHARMACEUTICAL DATA
   6.1 List of excipients

Copovidone
Isopropyl alcohol
Purified water

6.2 Incompatibilities

Not applicable.

6.3 Validity period

Shelf-life of the veterinary medicinal product packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 1 year.
6.4. Special storage precautions
This veterinary medicinal product does not require special storage conditions.
6.5 Nature and composition of immediate packaging
100 ml packaged in an opaque white high-density polyethylene bottle, closed
tightly by a mechanical spray pump delivering 0,5 mL per
spraying (low density polyethylene piston).
250 ml packaged in an opaque white high-density polyethylene bottle, closed
tightly by a mechanical spray pump delivering 1,5 mL per
spraying (low density polyethylene piston).
500 ml packaged in an opaque white high-density polyethylene bottle, closed
tightly by a mechanical spray pump delivering 1,5 mL per
spraying (low density polyethylene piston).
Not all formats may be marketed.

Any unused veterinary medicinal product or residues derived from it must be disposed of
in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
LABORATORIES CALIER, SA
Barcelona, ​​26 – PI El Ramassar
08520 Les Franqueses del Vallès
(Barcelona)
8. MARKETING AUTHORIZATION NUMBER(S)
3103 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization: 26 September of 2014
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Veterinary use-Medication not subject to veterinary prescription

See technical sheet

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