Pestigon for dogs 134mg 10-20kg 24pip

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
PESTIGON 134 mg SPOT-ON SOLUTION FOR MEDIUM DOGS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
A 1,34 ml pipette contains:
Sustancia assets

For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Spot-on dorsal anointing solution
Clear, colorless to pale yellow solution.
4. CLINICAL DATA
4.1 Target species
Dogs
4.2. Indications for use, specifying the target species.
For the treatment of flea infestations (Ctenocephalides felis). The medicine
shows an immediate insecticidal effect and a persistence against new infestations by
Adult flea up to 8 weeks.
The drug has an acaricidal efficacy against Ixodes ricinus up to 2 weeks,
Rhipicephalus sanguineusup to 3 weeks and Dermacentor reticulatus up to 4 weeks.
If ticks of this species are already present when the drug is applied, not all of them will be
deleted in the first 48 hours, but may be deleted in a week.
The drug can be used as part of the Dermatitis treatment program.
Flea allergy, when it has been previously diagnosed by a veterinarian.
4.3. contraindications
Do not use in dogs whose weight is less than 10 kg.
In the absence of available data, the drug should not be used in puppies less than
8 weeks old.

Do not use in sick animals (systemic diseases, fever...) or convalescents.
Do not use in rabbits, since adverse reactions to the active substance may occur.
or to some excipient.
This medication is specifically developed for dogs. Do not use it on cats, as
that this could lead to an overdose.
Do not use in animals with hypersensitivity to the active substance or to any of the excipients.
4.4. Special warnings for each target species
This medicine does not prevent the animal from being attacked by ticks, but ticks
they can die in the first 24-48 hours after they are hooked and before they are
have become completely swollen with blood so that the risk of disease transmission
it becomes minimal. Once dead, the ticks detach from the animal, but if there are
any remaining can be removed with a gentle tug.
When used as part of the treatment of Flea Allergy Dermatitis, it is recommended
Monthly applications for allergy sufferers and other dogs in the home.
For optimal control of flea problems in a multi-pet household,
all dogs and cats should be treated with an appropriate insecticide.
The tick may be attached. For this reason, the transmission of
infectious diseases cannot be completely eliminated if the conditions are
unfavorable. Pet fleas often infest the animal's basket, bedding
and the usual rest areas such as carpets and cushions, which must be
treated, in case of massive infection and at the start of control measures, with an insecticide
adequate and regular vacuuming.
Avoid frequent bathing or shampooing on the animal because the effectiveness of the
medication has not been investigated in these cases.
4.5. Special precautions for use
(i) Special precautions for use in animals:
Avoid contact with the animal's eyes. In case of accidental contact with eyes, rinse
immediately the eyes with water
For external use only.
Animals must be accurately weighed before starting treatment.
It is important to ensure that the medication is applied to an area where the animal will not
lick and make sure recently treated animals do not lick each other
others.
Do not apply the medicine on wounds or skin lesions.

(ii) Specific precautions to be taken by the person administering the medicinal product
to the animals.
This medication can cause irritation to the mucous membranes and eyes. Therefore, avoid contact
of the medicine with mouth and eyes.
In the event of accidental eye contact, immediately flush eyes with water. Yeah
If eye irritation persists, see a doctor immediately and show him the package leaflet.
People with a known hypersensitivity to fipronil or to any of its excipients (see
section 6.1) should avoid contact with this veterinary medicinal product.
Avoid that the substance comes into contact with the fingers. In the event that this occurs, wash the
hands with soap and water.
Wash hands after use. Do not smoke, drink, or eat during its application.
Treated animals should not be handled until the application point is dry and not
Children should be allowed to play with treated animals until the point of
injection is dry. Therefore, it is recommended that animals are not treated during the
day, but at sunset, and recently treated animals should be allowed to sleep
with their owners, especially with children.
(iii) Other precautions
Fipronil may adversely affect aquatic organisms. Dogs should not be bathed
in areas of water for two days after application.
The alcohol it contains may have an adverse effect on painted, varnished or
other types of surfaces in the home or furniture.
This product is flammable. Keep it away from heat, sparks, flames or other sources of
ignition.
4.6. Adverse reactions (frequency and seriousness)
If the animal licks itself, a period of hypersalivation may be observed mainly due to
the nature of the excipient.
Among the extremely rare suspected adverse reactions, there have been
transient skin reactions at the point of application (desquamation, local alopecia, pruritus,
erythema) and general pruritus or alopecia after use. In exceptional cases, it has been observed
hypersalivation, reversible neurological signs (hyperesthesia, depression, nervous signs) or
vomiting
Do not exceed the dose.
4.7. Use during pregnancy, lactation and lay
Laboratory studies using fipronil have not shown any teratogenic effects and
fetotoxic.

In the absence of studies to evaluate the safety of this drug in animals
pregnant or lactating, use this medicinal product only after benefit/risk assessment
by the responsible veterinarian.
4.8. Interaction with other medicinal products and other forms of interaction
none known
4.9. Dosage and routes of administration
Route of administration: by topical application on the skin.
For external use only. Apply the product directly on the skin, depending on the
animal weight.
Dose:
one 1,34 ml pipette per dog whose body weight is 10-20 kg.
Administration method: hold upright. Tap to make sure
that all the liquid content is inside the main body of the pipette. detach
the upper part by the dashed line. Part the hair between the shoulder blades until the skin
be visible. Place the pipette tip on the skin and squeeze the pipette to empty its
contained in the skin, preferably in a colon.
1. Fold along the diagonal line where the dent is.
2. Break by the dent
3. Rotate the lid to open it
4. Part hair, apply to skin.
It is important to ensure that the product is applied in an area where the animal will not
You can remove it by licking it, and also ensure that if there are several animals they do not lick each other.
others after treatment.
Care should be taken to avoid excessive wetting of the hair with the drug.
as this will produce a sticky appearance of the hair at the point of treatment. Without

However, should this occur, it will disappear within 24 hours of the
application.
To achieve optimal control of flea and/or mite infestation, the treatment program
it can be based on the local epidemiological situation.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects have been observed in animal safety studies as
eight week old puppies, growing dogs and dogs that weigh around 2
kg, were treated on 3 occasions with 5 times the recommended dose. The risk of
experiencing adverse effects (see section 4.6) may increase when a
overdosing, and therefore animals should always be treated with the correct size of
the pipette depending on the weight of the animal.
4.11. Waiting time
Not applicable
5. PHARMACOLOGICAL PROPERTIES
Pharmaceutical group: Ectoparasiticides for topical use.
ATCvet code: QP53AX15
5.1. Pharmacodynamic properties
Fipronil is an insecticide/miticide that belongs to the family of phenylpyrazoles. act
by inhibiting the GABA complex, binding to the chloride channel and thus blocking the
pre- and post-synaptic transfer of chloride ions across the membrane. This gives like
result in uncontrolled activity of the central nervous system and therefore the death of
insects and mites.
Fipronil acts as an insecticide against fleas (Ctenocephalides felis) and as an acaricide
against ticks (Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes ricinus) en
dogs.
Incoming fleas are killed within 24 hours of landing on the animal. ticks, yeah
Some are hooked when the medicine is applied, perhaps they will not die in the
first 48 hours but will die in the next 9 days after treatment.
This medication is effective against flea infestation (Ctenocephalides felis) during
approximately 8 weeks and against ticks up to 4 weeks (see the indications
before use), depending on the species of tick and the level of challenge.
5.2. Pharmacokinetic data
After local application of fipronil in the dog, it is slowly absorbed through the skin.
Low levels of fipronil have been detected in plasma, with a wide range between
dogs. After application, there is a good distribution of the chemical in the

hair, showing a good concentration gradient between the area where the
medication and the peripheral zone.
Fipronil is mainly metabolized to its sulfone derivative (RM1602), which is also
It has insecticidal and acaricidal properties.
Fipronil concentrations on fur decrease with time.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Butylated hydroxyanisole (E320)
Butylated hydroxytoluene (E321)
Povidone K12
Polysorbate 80
butyl alcohol
Diethylene glycol monoethyl ether
6.2 Incompatibilities
none known
6.3. Period of validity
Shelf life of the veterinary medicinal product packaged for sale: 2 years.
6.4. Special storage precautions
This medicine does not require any special temperature for its conservation. Keep
in the original container in order to protect from light and moisture.
6.5. Nature and composition of the immediate packaging
1,34ml pipettes, molded by a surface composed of three layers: a layer of
polypropylene/COC/polypropylene, a lacquer-free solvent sheet, and a layer of
polyethylene/EVOH/polyethylene copolymer. Pipettes are sealed inside envelopes
composed of four layers of LDPE/nylon/aluminum foil/polyester layer
child resistant and presented in a box.
Boxes containing 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90, 120 or 150 pipettes.
Not all formats may be marketed.
6.6. Special precautions for disposal of the veterinary medicinal product
used or, where appropriate, the residues derived from its use.
All unused medication or residues derived from it must be disposed of
accordance with local regulations.

This medicine should not be disposed of by dumping it into watercourses as it can
be dangerous to fish and other aquatic organisms. Do not contaminate ponds, pathways
rivers or ditches with the medicine or with the empty container.
7. MARKETING AUTHORIZATION HOLDER
Nobrook Laboratories Ltd,
Station Works,
Newry,
Co Down,
BT35 6JP,
United Kingdom.
8. MARKETING AUTHORIZATION NUMBER(S)
2601 ESP
9. DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE
AUTHORIZATION.
August 28th, 2012
10. DATE OF REVISION OF THE TEXT
June 11th, 2013
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Dispensing conditions: Medicine not subject to veterinary prescription.

See technical sheet