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POM-V Prescription Required Companion Animal

Ataxxa 1250 mg/250 mg Spot-on Solution for Dogs over 10 kg up to 25 kg

Active ingredients: Imidacloprid, Permethrin (Cis:Trans 40:60)

Form

Spot-on

Species

Dogs

Manufacturer

KRKA, d.d., Novo mesto

VMD MA No.

01656/3036

What it's used for

Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The veterinary medicinal produ...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Clinical information

Ataxxa 1250 mg/250 mg Spot-on Solution for Dogs over 10 kg up to 25 kg — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

Fleas on dogs are killed within one day following treatment. One treatment prevents
further flea infestation for four weeks. The veterinary medicinal product can be used
as part of a treatment strategy for flea allergy dermatitis (FAD).
The veterinary medicinal product has persistent acaricidal efficacy against tick
infestations (Rhipicephalus sanguineus and for four weeks, and
Dermacentor reticulatus for three weeks) and persistent repellent efficacy (Ixodes
ricinus) for three weeks.
Ticks already on the dog may not be killed within two days after treatment and may
remain attached and visible. Therefore the removal of ticks already on the dog at the
time of treatment is recommended, in order to prevent them from attaching and
having a blood meal.
One treatment provides repellent (anti-feeding) activity against the sand fly
Phlebotomus perniciosus for three weeks and against the mosquito Aedes aegypti
from 7 days up to 14 days after treatment.
Reduction of the risk of infection with Leishmania infantum via transmission by
sandflies (Phlebotomus perniciosus) for up to 3 weeks. The effect is indirect due to
the veterinary medicinal product's activity against the vector.
The recommended minimum dose is:
10 mg/kg body weight (bw) imidacloprid and 50 mg/kg body weight (bw) permethrin.
Administer by topical application to the skin according to the bodyweight as follows:
For dogs > 40 kg the appropriate combination of pipettes should be used.
To ensure correct dosage, body weight should be determined as accurately as
possible.
To reduce re-infestation from emergence of new fleas, it is recommended to treat all
dogs in a household. Other animals living in the same household should also be
treated with a suitable veterinary medicinal product. To aid further in reducing
environmental challenge, the additional use of a suitable environmental treatment
against adult fleas and their developmental stages is recommended.
Depending on the ectoparasite challenge, it may be necessary to repeat the treatment.
The interval between two treatments should be 4 weeks. However, in cases of frequent
and/or prolonged water exposure the persistent efficacy may be reduced. In these
cases do not retreat more frequently than once weekly.
Dogs (kg
body weight)
Trade nameVolume
(ml)
Imidacloprid
(mg/kg body
weight)
Permethrin
(mg/kg body
weight)
 4 kgAtaxxa 200 mg/40
mg spot-on solution
for dogs up to 4 kg
0.4 mlminimum of 10minimum of 50>4 kg  10 kgAtaxxa 500 mg/100
mg spot-on solution
for dogs over 4 kg up
to 10 kg
1.0 ml10 - 2550 - 125>10 kg  25 kgAtaxxa 1250 mg/250
mg spot-on solution
for dogs over 10 kg
up to 25 kg
2.5 ml10 - 2550 - 125>25 kg  40 kgAtaxxa 2000 mg/400
mg spot-on solution
for dogs over 25 kg
4.0 ml10 - 1650 - 80
To protect a dog over the whole sand fly season, treatment should be compliantly
continued throughout.
Transient cosmetic changes (e.g. skin scaling, white deposits and spiking of the hair)
may be observed at application sites.
Method of administration:
Remove one pipette from the package. Hold applicator pipette in an upright position.
Tap the narrow part of pipette to ensure the contents are within the main body of the
pipette, twist and pull cap off. Turn the cap around and place the other end of cap
back on pipette. Push and twist the cap to break seal, and then remove the cap from
the pipette.
For dogs 10 kg body weight or less:
With the dog standing still, part the coat between the shoulder blades until the skin is
visible. Place the tip of the pipette on the skin and squeeze firmly several times to
empty the contents directly onto the skin.
For dogs of more than 10 kg body weight:
With the dog standing still, the entire contents of the pipette should be applied evenly
to four spots on the top of the back from the shoulder to the base of the tail. At each
spot, part the hair until the skin is visible. Place the tip of the pipette on the skin and
gently squeeze to expel a portion of the solution on the skin. Do not apply an
excessive amount of solution at any one spot that could cause some of the solution
to run off the side of the dog.
In the absence of available data do not use the veterinary medicinal product on
puppies of less than 7 weeks of age, or 10 kg of weight.
Do not use in known cases of hypersensitivity to the active substances or to any of
the excipients.
Do not use on cats. (Refer to section 3.5 – Special precautions for use).
Dogs
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Application site disorders (application site
pruritus, application site hair loss, application site
erythema, application site oedema, and
application site lesions)
Behavioural disorders (agitation, restlessness,
whining or rolling)
Digestive tract disorders (vomiting, diarrhoea,
hypersalivation, decreased appetite)
Neurological disorders (e.g. unsteady gait,
twitching, lethargy)
2,3
generally self-resolving
generally transient and self-resolving
in dogs susceptible to the ingredient permethrin
Accidental oral uptake may result in transient vomiting and neurological disorders
such as tremors and incoordination. Treatment should be symptomatic. There is no
known specific antidote.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also section 16 of the
package leaflet for respective contact details.
There may be an attachment of single ticks or bites by single sand flies or Aedes
aegypti
excluded if conditions are unfavourable.
As the veterinary medicinal product exerts a repellent (anti-feeding) activity against
Aedes aegypti mosquitoes 7 days after treatment, the veterinary medicinal product
should preferably be applied 1 week before animals are likely to become exposed to
these mosquitoes.
The veterinary medicinal product remains effective against fleas if the animal
becomes wet. After weekly immersions in water for one minute the period of
persistent insecticidal efficacy against fleas was not reduced. However, prolonged,
intense exposure to water should be avoided. In cases of frequent and/or prolonged
water exposure the persistent efficacy may be reduced. In these cases do not retreat
more frequently than once weekly. If a dog requires a shampoo, it should be
administered before applying the veterinary medicinal product or at least 2 weeks
after application, to optimise efficacy of the veterinary medicinal product.
The effectiveness of the veterinary medicinal product against ticks following
swimming or shampooing has not been investigated.
Immediate protection against sandflies bites is not documented. Treated dogs for the
reduction of the risk of infection with Leishmania infantum via transmission by
sandflies P. perniciosus should be kept in a protected environment during the first 24
hours after the initial treatment application.

Special precautions for use in animals
Care should be taken to avoid the content of the pipette coming into contact with the
eyes or mouth of the recipient dogs.
Care should be taken to administer the veterinary medicinal product correctly as
described under section 3.9. In particular oral uptake due to the licking of the
application site by treated or in-contact animals should be avoided.
Do not use on cats.
This veterinary medicinal product is extremely poisonous to cats and could be fatal
due to the unique physiology of cats which is unable to metabolise certain
compounds including permethrin. To prevent cats from being accidentally exposed to
the veterinary medicinal product, keep treated dogs away from cats after treatment
until the application site is dry. It is important to ensure that cats do not groom the site
of application on a dog, which has been treated with this veterinary medicinal
product. Seek veterinary advice immediately if this occurs.
Consult your veterinary surgeon before using the veterinary medicinal product on sick
and debilitated dogs.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Avoid contact between the veterinary medicinal product and skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with known skin sensitivity may be particularly sensitive to this veterinary
medicinal product.
The predominant clinical symptoms that in extremely rare case may be shown are
transient sensory irritations of the skin like tingling, burning sensation or numbness.
If the veterinary medicinal product gets accidentally into the eyes, they should be
thoroughly flushed with water. If skin or if eye irritation persists, seek medical advice
immediately and show the package leaflet or the label to the physician.
Do not ingest. In case of accidental ingestion seek medical advice immediately and
show the package leaflet or the label to the physician.
Treated dogs should not be handled especially by children until the application site is
dry. This may be ensured by treating the dogs in the evening. Recently treated dogs
should not be allowed to sleep together with their owner, especially children.
In order to prevent children from getting access to pipettes, keep the pipette in the
original packaging until ready for use and dispose of used pipettes immediately.
Special precautions for the protection of the environment:
The veterinary medicinal product is toxic for aquatic organisms. Treated dogs should
not be allowed to enter surface water for 48 hours after treatment, to avoid adverse
effects on aquatic organisms.
Other precautions
The solvent in the veterinary medicinal product may stain certain materials including
leather, fabrics, plastics and finished surfaces. Allow the application site to dry before
permitting contact with such materials.
None known.
Store in the original packaging in order to protect from light and moisture.
Not applicable.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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