Ataxxa 200 mg/40 mg Spot-on Solution for Dogs up to 4 kg

Composition

Each 0.4 ml pipette contains:

Active substances:

Permethrin 200.0 mg

Imidacloprid 40.0 mg

Excipients:

Quantitative composition if that

Qualitative composition of information is essential for proper excipients and other constituents administration of the veterinary medicinal product

Butylhydroxytoluene (E321) 0.4 mg

N-methylpyrrolidone 80.0 mg

Triglycerides, Medium-Chain

Citric acid (E330)

Dimethyl sulfoxide

Clear yellowish to brownish spot on solution.

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Pharmacological properties

4.1 ATCvet code: QP53AC54.

4.2 Pharmacodynamics

The veterinary medicinal product is an ectoparasiticide for topical use containing imidacloprid and permethrin. This combination acts as an insecticide and acaricide.

Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the dog`s immediate surroundings are killed following contact with a treated animal. It has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) in insects. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death of the parasite.

Permethrin belongs to the type I class of pyrethroid acaricides and insecticides. Pyrethroids affect the voltage-gated sodium channels in vertebrates and non- vertebrates. Pyrethroids are so called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties thus leading to hyperexcitability and death of the parasite.

In the combination of both substances, it has been shown Imidacloprid functions as the activator of arthropod ganglion and therefore increases the efficacy of permethrin.

4.3 Pharmacokinetics

Following topical application in dogs, the solution distributes over the body surface of the animal. Both active substances remain on the skin and hair of the treated animal for at least 4 weeks. Systemic absorption of the veterinary medicinal product is sufficiently low so as not to affect efficacy or target species tolerance.

Environmental properties

The veterinary medicinal product should not be allowed to enter water courses as this may be dangerous for fish and aquatic organisms. For treated dogs, please see section 3.5.

Permethrin containing products are toxic to honey bees.

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Target species

Dogs

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Indications

For the treatment and prevention of flea (Ctenocephalides felis) infestation.

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 Ixodes ricinus 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.

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Dosage

Spot-on use only. Apply only to undamaged skin.

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.

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.

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Contraindications

In the absence of available data do not use the veterinary medicinal product on puppies of less than 7 weeks of age, or 1.5 kg of weight.

Do not use in 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).

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Adverse reactions

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)1

Behavioural disorders (agitation, restlessness, whining or rolling)2

Digestive tract disorders (vomiting, diarrhoea, hypersalivation, decreased appetite)2

Neurological disorders (e.g. unsteady gait, twitching, lethargy)2,3

1 generally self-resolving

2 generally transient and self-resolving

3 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 the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established in dogs during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

None known.

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Overdose

No adverse clinical signs were noted in healthy puppies or adult dogs exposed to 5x overdosage or for puppies whose mothers were treated with 3x overdosage of the combination of imidacloprid and permethrin. The severity of skin erythema, which sometimes occurs at the application site, increases with overdose.

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Special warnings

There may be an attachment of single ticks or bites by single sand flies or Aedes aegypti mosquitoes. For this reason, a transmission of infectious diseases cannot be 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.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag.

1 ml pipette containing 0.4 ml of solution

Pack sizes:

Box containing 1, 3, 4, 6, 10 pipettes.

Not all pack sizes may be marketed.

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Storage

Store in the original packaging in order to protect from light and moisture.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

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Disposal of unused product

product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as permethrin/imidacloprid may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 01656/5034

8 DATE OF FIRST AUTHORISATION

20 November 2015

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

August 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 02 September 2026

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Registration holder

KRKA, d.d., Novo mesto

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