SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4.0 ml pipette contains:

Active substances:

Permethrin 2000.0 mg

Imidacloprid 400.0 mg

Excipients:

Butylhydroxytoluene (E321) 4.0 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Spot-on solution.

Clear yellowish to brownish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

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 product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

4.3 Contraindications

In the absence of available data do not use the product on puppies of less than 7 weeks of age, or 25 kg of weight.

Do not use in case of hypersensitivity to the active substances or to any of the excipients.

Do not use on cats. (Refer to section 4.5 – Special precautions for use).

4.4 Special warnings for each target species

The 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 product or at least 2 weeks after application, to optimise efficacy of the product.

4.5 Special precautions for use

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 product correctly as described under section 4.9. 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 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 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 product. Seek veterinary advice immediately if this occurs.

Consult your veterinary surgeon before using the 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 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 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 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.

iii) Other precautions

The solvent in the product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

4.6 Adverse reactions (frequency and seriousness)

Pruritus, hair loss, erythema, oedema and erosions at the application site may occur. These are generally self-resolving.

In very rare cases dogs may show behaviour changes (agitation, restlessness, whining or rolling), gastro-intestinal symptoms (vomiting, diarrhoea, hypersalivation, diminished appetite) and neurological signs such as unsteady movement and twitching, or lethargy in dogs susceptible to the ingredient permethrin. These signs are generally transient and self-resolving.

Accidental oral uptake may result in transient vomiting and neurological signs such as tremor and incoordination. Treatment should be symptomatic. There is no known specific antidote.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. In these animals, use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Route of administration and 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 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 fleachallenge, 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.

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 capto 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. Insecticides, permethrin, combinations.

ATCvet code: QP53AC54.

5.1 Pharmacodynamic properties

The product is an ectoparasiticide for topical use containing imidacloprid and permethrin.

Imidaclopridis 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.

Permethrinbelongs to the type I class of pyrethroids. 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.

5.2 Pharmacokinetic particulars

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 product is sufficiently low so as not to affect efficacy or target species tolerance.

Environmental properties

The 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 4.5.

Permethrin containing products are toxic to honey bees.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxytoluene (E321)

Triglycerides, Medium-Chain

N-methylpyrrolidone

Citric acid, anhydrous (E330)

Dimethyl sulfoxide

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

6.4. Special precautions for storage

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

6.5 Nature and composition of 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.

6 ml pipette containing 4 ml of solution

Box containing 1, 4, 6, 10 pipettes.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.

After use, replace cap on tube. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

8. MARKETING AUTHORISATION NUMBER

Vm 01656/4094

9. DATE OF FIRST AUTHORISATION

16 December 2015

10. DATE OF REVISION OF THE TEXT

December 2015

Approved: 16 December 2015