PACKAGE LEAFLET

1. Name of the veterinary medicinal product

Dehispot 30 mg/7.5 mg spot-on solution for small cats

Dehispot 60 mg/15 mg spot-on solution for medium-sized cats

Dehispot 96 mg/24 mg spot-on solution for large cats

2. Composition

Each unit dose (pipette) contains:

Active substances

Excipient

Butylhydroxyanisole (E320): 5.4 mg/ml.

Clear, colourless to yellow or brown solution.

3. Target species

Cats.

4. Indications for use

For use in cats with mixed parasitic infestations or at risk of infestation with roundworms and tapeworms against which each active substance in the combination is effective.

This veterinary medicinal product is indicated only when treatment against roundworms and tapeworms is required at the same time.

Roundworms (nematodes)

• Toxocara cati — mature adults, immature adults, L3 and L4 larvae.

• Toxocara cati — L3 larvae; for the treatment of queens during late pregnancy to prevent transmission of the infestation to their offspring through milk.

• Toxascaris leonina — mature adults, immature adults and L4 larvae.

• Ancylostoma tubaeforme — mature adults, immature adults and L4 larvae.

Tapeworms (cestodes)

• Dipylidium caninum — mature and immature adults.

• Taenia taeniaeformis — adults.

• Echinococcus multilocularis — adults.

5. Contraindications

Do not use in kittens younger than eight weeks of age or weighing less than:

• 0.5 kg for the veterinary medicinal product intended for small cats;

• 2.5 kg for the veterinary medicinal product intended for medium-sized cats;

• 5 kg for the veterinary medicinal product intended for large cats.

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

6. Special warnings

Special warnings

Unnecessary use of antiparasitic products or use that does not comply with the instructions in the Summary of Product Characteristics may increase the selection pressure for resistance and reduce treatment efficacy.

The decision to use this veterinary medicinal product should be based on confirmation of the parasite species and parasite burden in each individual animal, or on the risk of infestation based on its epidemiological characteristics.

Where there is no risk of co-infestation, a narrow-spectrum veterinary medicinal product should be used.

Consideration should be given to the possibility that other animals in the same household may be a source of repeated nematode and/or tapeworm infestation. Where necessary, their infestations should be treated with an appropriate veterinary medicinal product.

Where an infestation with the tapeworm Dipylidium caninum has been confirmed, simultaneous treatment against intermediate hosts, such as fleas and lice, should be discussed with a veterinarian to prevent reinfestation.

Frequent and repeated use of anthelmintics from this group may result in parasite resistance to anthelmintics of any group.

Resistance of Dipylidium caninum to praziquantel has been reported in dogs.

When using this veterinary medicinal product, local information concerning the susceptibility of the target parasites should be taken into account, where available.

Further investigation using an appropriate diagnostic method is recommended in cases of suspected resistance.

Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.

Shampooing or immersing the animal in water immediately after treatment may reduce the effectiveness of this veterinary medicinal product. Treated animals should therefore not be washed until the solution has dried.

Special precautions for safe use in the target species

Apply only to intact, undamaged skin.

Do not administer orally or parenterally.

After treatment, do not allow the treated cat or other cats to lick the application site while it is still wet.

There is insufficient experience with the use of this veterinary medicinal product in sick or debilitated animals. It should therefore only be used in such animals following an assessment of the potential benefit-risk balance by the treating veterinarian.

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

This veterinary medicinal product may cause irritation to the skin and eyes.

In the event of accidental contact with the skin, wash immediately with soap and water.

If the veterinary medicinal product accidentally comes into contact with the eyes, rinse them with plenty of water.

If skin or eye symptoms persist after rinsing, or in the event of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.

Avoid direct contact with the treated area while it is still wet.

During the first 24 hours after application, children should not have prolonged and close contact with the treated animal, such as sleeping next to it.

Do not smoke, eat or drink while handling this veterinary medicinal product.

Wash hands after handling the veterinary medicinal product.

Other precautions

The solvent contained in this veterinary medicinal product may stain leather, fabrics, plastics and other surfaces. Allow the application site to dry before permitting contact with such materials or surfaces.

Echinococcosis represents a hazard to humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (WOAH), specific guidance on treatment, follow-up and human safety should be obtained from the relevant competent authorities.

Pregnancy and lactation

May be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Emodepside is a substrate for P-glycoprotein.

Concurrent treatment with other substances that are substrates or inhibitors of P-glycoprotein, such as ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and ciclosporin, may increase the possibility of pharmacokinetic interactions.

The possible clinical consequences of such interactions have not been investigated.

When your cat is receiving any other medicinal products, contact your veterinarian to discuss this before using this veterinary medicinal product.

You should also inform your veterinarian that this veterinary medicinal product is being used if the veterinarian administers any other medicinal product to your cat.

Overdose

Salivation, vomiting and neurological signs such as tremors were occasionally observed when this veterinary medicinal product was administered at ten times the recommended dose to adult cats and five times the recommended dose to kittens.

These signs may have been caused by the animal licking the application site after treatment. The signs were completely reversible.

There is no known specific antidote.

Major incompatibilities

None known.

7. Adverse events

Cats

Very rare — fewer than 1 animal in 10,000 animals treated, including isolated reports:

• Transient alopecia at the application site;

• transient itching at the application site;

• transient inflammation at the application site;

• salivation;

• vomiting;

• diarrhoea;

• loss of appetite;

• mild and transient neurological disorders;

• behavioural disorders.

Salivation, vomiting, diarrhoea and certain neurological signs may occur as a result of licking the application site immediately after treatment.

Neurological disorders may include ataxia or tremors.

Behavioural disorders may include hyperactivity, anxiety and increased vocalisation.

Reporting adverse events is important. It allows continuous monitoring of the safety of a veterinary medicinal product.

When you notice any adverse events, including those not listed in this package leaflet, or you believe that the veterinary medicinal product has not worked, please inform your veterinarian.

You may also report adverse events directly to the marketing authorisation holder or its local representative using the contact details provided at the end of this package leaflet, or through the national reporting system on the website of the Food and Veterinary Service: www.pvd.gov.lv.

8. Dosage for each species, routes and method of administration

For spot-on use.

To ensure administration of the correct dose, the animal’s body weight should be determined as accurately as possible.

Underdosing may result in ineffective treatment and may promote the development of resistance.

Dosage and treatment schedule

The recommended minimum doses are:

• 12 mg praziquantel per kg of body weight;

• 3 mg emodepside per kg of body weight.

This corresponds to 0.14 ml of the veterinary medicinal product per kg of body weight.

A single treatment is effective for the treatment of roundworm and tapeworm infestations.

For the treatment of pregnant queens to prevent transmission of Toxocara cati L3 larvae to their offspring through milk, a single treatment approximately seven days before the expected date of birth is effective.

9. Advice on correct administration

For external use only.

1. Remove the pipette from the package. Hold the pipette upright, twist and remove the cap.

2. Turn the cap over and place the opposite end back onto the pipette. Press and twist the cap to break the seal, and then remove the cap from the pipette.

3. Part the animal’s coat at the base of the neck, in front of the shoulder blades, until the skin is visible. Place the tip of the pipette directly against the skin and squeeze it several times until the entire contents of the pipette have been applied directly to the skin.

Avoid contact between the veterinary medicinal product and your fingers.

Application at the withers reduces the possibility of the animal licking off the veterinary medicinal product.

10. Withdrawal period

Not applicable.

11. Special storage precautions

Keep out of the sight and reach of children.

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

This veterinary medicinal product does not require any special temperature storage conditions.

Do not use this veterinary medicinal product after the expiry date stated on the label and carton after “Exp.”

The expiry date refers to the last day of the stated month.

12. Special precautions for disposal

Medicines should not be disposed of via wastewater or household waste.

This veterinary medicinal product must not enter watercourses, as emodepside may be dangerous to fish and other aquatic organisms.

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

These measures help protect the environment.

Ask your veterinarian or pharmacist how to dispose of veterinary medicinal products that are no longer required.