ADVANTIX 40-60KG

Advantix spot-on solution for dogs weighing over 40 kg up to 60 kg .

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each 6.0 ml pipette contains:

Active substances:

Imidacloprid 600.0 mg

Permethrin (40/60) 3000.0 mg

Excipients:

Butylhydroxytoluene (E321) 6.0 mg

4. INDICATION(S)

For the treatment and prevention of flea infestations (Ctenocephalides canis, Ctenocephalides felis) and for the treatment of mange lice infestations (Trichodectes canis) in dogs.

Fleas present on the dog are killed after one day of treatment. One treatment prevents future flea infestations for four weeks.

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

The product has acaricidal and repellent (removal) activity against tick infestations (Rhipicephalus sanguineus and Ixodes ricinus for up to four weeks and Dermacentor reticulatus for up to three weeks).

By repellent and killing activity on the tick vector Rhipicephalus sanguineus the product reduces the transmission of the pathogen Ehrlichia canis and thus reduces the risk of canine ehrlichiosis. The risk reduction has been demonstrated in studies to start 3 days after application of the product and to be effective for up to 4 weeks.

Ticks already present on the dog may not be killed within two days of treatment and may remain attached and visible. It is therefore recommended to remove ticks present on the dog at the time of treatment to prevent them from attaching and feeding on blood.

One treatment provides repeated action (anti-feeding) against sandflies (Phlebotomus papatasi for two weeks and Phlebotomus perniciosus for three weeks) against mosquitoes (Aedes aegypti for two weeks and Culexpipiens for four weeks) and against dung flies (Stomoxys calcitrans) for four weeks.

5. CONTRAINDICATIONS

In the absence of available data, the product should not be used in puppies less than 7 weeks of age or with a body weight of less than 40 kg. Depending on the body weight of the dog, the appropriate Advantix product should be used.

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

Do not use in cats.

6. ADVERSE REACTIONS

In very rare cases, dogs may experience transient dermal sensitivity reactions (with increased local itching, scratching and flaking, hair loss and erythema at the application site) or apathy which are generally transient,

In very rare cases, dogs may show behavioural changes (agitation, restlessness, crying and rolling), gastrointestinal symptoms (vomiting, diarrhoea, hypersalivation, decreased appetite) and neurological signs such as unsteady movements and muscle convulsions in dog breeds sensitive to the active substance permethrin. These signs are generally transient and are transient.

In very rare cases, poisoning of dogs may occur after accidental ingestion. In these cases, neurological signs such as tremors and apathy may also occur. Symptomatic treatment should be applied. There is no specific antidote.

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

- Very common (more than 1 in 10 animals treated displaying adverse reactions)

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

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

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

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

If you notice any adverse reactions, even those not already listed in this package leaflet, or you think that the medicinal product has had no effect, please inform your veterinary surgeon.

7. TARGET SPECIES

For dogs weighing 40 kg or more up to and including 60 kg. For dogs weighing more than 60 kg, use Advantix Spot-on in the product combination appropriate to the animal's weight (see section 8).

8. DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION

The minimum recommended dose is:

10 mg imidacloprid/kg body weight and 50 mg permethrin/kg body weight.

For dogs weighing more than 60 kg, the appropriate combination with a different size pipette should be used.

To reduce re-infestations with new fleas, it is recommended to treat all dogs in a family (household). Other pets in the same family or household should be treated with appropriate products. For fleas from the animal's environment, it is recommended to use an additional product appropriate for the treatment of adult fleas and their developmental stages.

The product is active even if the animal is wet. However, prolonged and intense exposure to water should be avoided. If frequent exposure to water occurs, the effectiveness of the product decreases. Even in this case, the dog should not be treated more frequently than once a week.

If it is necessary to wash the animal with shampoo, it should be administered before Advantix or the veterinary medicinal product should be applied 2 weeks after shampooing to ensure the effectiveness of the product.

In infestations with malophagous lice after 30 days of treatment, a new examination by the veterinarian is recommended and a second treatment may be necessary in some animals.

Method of administration:

Remove a pipette from the package. Hold the pipette in an upright position, twist the cap and remove it. Turn the cap upside down and use it to unseal the pipette. By twisting and pressing on the seal and then removing the cap from the pipette.

With the dog standing, the entire contents of the Advantix pipette should be applied evenly to four areas starting from between the shoulders to the base of the tail. In each area, remove the hair until the skin becomes visible. Apply the tip of the pipette to the skin and squeeze gently to release some of the solution onto the skin.

9. ADVICE ON CORRECT ADMINISTRATION

For external use only.

Apply only to intact skin.

Do not apply a large amount of solution to one area as it may run down the sides of the dog's body.

10. WITHDRAWAL TIME

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not freeze.

After opening the bag, store in a dry place and do not store above 30°C.

Use within 12 months of opening the pouch or before the expiry date, whichever is the shorter.

Do not use this veterinary medicinal product after the expiry date which is stated on the pipette, pouch or carton after EXP. The expiry date refers to the last day of that month.

12. SPECIAL WARNING(S)

Special warnings for each target species:

There may be a single attached tick or the bite of a sandfly or mosquito. Therefore the transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable. However, the product provides repellent action (anti-feeding) against ticks, sandflies and mosquitoes and in this way prevents the parasites from feeding on blood and reduces the risk of transmission of vector-borne diseases to dogs (Canine Vector-Bome Disease - CVBD, such as borreliosis, rickettsiosis, ehrlichiosis, leishmaniasis).

It is recommended to apply the treatment 3 days before possible exposure to E. canis. Regarding E. canis, studies have shown that it reduces the risk of canine ehrlichiosis in dogs exposed to Rhipicephalus sanguineus ticks infected with E. canis from 3 days after application of the product and having an effect for up to 4 weeks.

Special precautions for use in animals:

The contents of the pipette must not come into contact with the eyes and mouth of the dog receiving the treatment.

Attention to the correct administration of the product as described in the Method of administration section. In particular, oral ingestion through the application site ointment or contact with other animals should be avoided.

Do not use in cats.

This product is highly toxic to cats and can cause death due to the unique physiological characteristics of cats that are not able to metabolize certain compounds, including permethrin. To prevent accidental exposure of cats to this product, treated dogs should be kept separate from cats after treatment until the application site is dry. Care should be taken to ensure that cats do not lick the application site of dogs that have been treated with this product. Seek veterinary advice immediately if this occurs.

Consult your veterinarian before using this product on sick or debilitated animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after applying the product.

If the product accidentally gets on the skin, wash the area immediately with soap and water.

People with known skin sensitivities may be particularly sensitive to this product, in very rare cases the predominant clinical symptoms are transient skin irritations manifested by tingling, burning sensation or numbness.

If the product accidentally gets into the eyes, rinse the eyes with plenty of water. If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not swallow. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the doctor.

Treated dogs should not be handled, especially by children, until the application site is dry. To be on the safe side, treat dogs, for example, in the evening. In this case, treated dogs should not be allowed to sleep with their owners, especially children.

To prevent children from accessing the pipettes, keep the pipettes in their original packaging until ready for use and dispose of used pipettes immediately.

Other precautions:

As the product is dangerous for aquatic organisms, treated dogs should under no circumstances be left in any type of surface water for at least 48 hours after treatment.

The solvent in Advantix spot-on solution may stain certain materials such as leather, fabrics, plastic and finished surfaces. Allow the application site to dry before contact with such materials.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Interactions with other medicinal products or other forms of interaction:

None known.

Overdose (symptoms, emergency procedures, antidotes):

No adverse clinical signs were observed in healthy adult dogs and puppies treated with an overdose of 5 times the standard dose, nor in puppies whose mothers were treated with an overdose of 3 times the standard dose of the product.

Incompatibilities:

None known.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

After use, close the pipette with the cap.

Medicines should not be thrown away via wastewater or household waste. Ask your veterinarian for information on how to dispose of medicines no longer required. These measures help to protect the environment.

14. OTHER INFORMATION

Advantix Spot-on is an ectoparasiticide for external use containing imidacloprid and permethrin. This combination acts as an insecticide, acaricide and repellent.

Imidacloprid is effective against adult fleas and their larval stages. In addition to the efficacy shown against adult fleas, the substance has also been shown to be larvicidal for areas in the animal's habitat. Larval stages in the animal's environment are killed as a result of contact with a treated animal.

Package sizes: 6.0 ml per pipette; package containing 1 individual pipette.