Itch Wormer Spot On Plus 96 mg/24 mg Spot-on Solution for Large Cats

Composition

Each ml contains 85.8 mg/ml of praziquantel and 21.4 mg/ml of emodepside.

Each 1.12 ml pipette contains:

Active substances:

Praziquantel 96 mg

Emodepside 24 mg

Excipients:

Clear, colourless to yellow or to brown solution.

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Pharmacological properties

4.1 ATCvet code: QP52AA51

4.2 Pharmacodynamics

Praziquantel is a pyrazinoisoquinoline derivative effective against tapeworms such as Dipylidium caninum, Echinococcus multilocularis, and Taenia taeniaeformis. Praziquantel is rapidly adsorbed via the surface of the parasites and acts primarily by changing the Ca++ permeability of the parasite membranes. This results in severe

damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.

Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides. It is active against roundworms (ascarids and hookworms). In this veterinary medicinal product, emodepside is responsible for the efficacy against Toxocara cati, Toxascaris leonina, and Ancylostoma tubaeforme.

It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin receptor family which results in paralysis and death of the parasites.

4.3 Pharmacokinetics

After topical application of an equivalent veterinary medicinal product to cats at the minimum therapeutic dose of 0.14 ml/kg bodyweight, mean maximum serum concentrations of 32.2 ± 23.9 μg emodepside/l and 61.3 ± 44.1 μg praziquantel/l were observed. Maximum concentrations were reached for 18.7 ± 47 hours after application for praziquantel and emodepside 3.2 ± 2.7 days. Both active substances are then slowly eliminated from the serum with a half-life of 4.1 ± 1.5 days for praziquantel and 9.2 ± 3.9 days for emodepside.

Studies in many different species show that praziquantel is rapidly metabolised in the liver. The main metabolites are monohydroxycyclohexyl derivatives of praziquantel. Renal elimination predominates.

After oral application in the rat, emodepside is distributed to all organs. Highest concentration levels are found in the fat. Faecal excretion predominates with unchanged emodepside and hydroxylated derivatives as the major excretion products.

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Target species

Large cats (greater than 5 – 8 kg).

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Indications

For the treatment of mixed parasitic infections in cats caused by roundworms and tapeworms of the following species:

Roundworms (Nematodes):

Toxocara cati (mature adult, immature adult, L4 and L3)

Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring

Toxascaris leonina (mature adult, immature adult and L4)

Ancylostoma tubaeforme (mature adult, immature adult and L4)

Tapeworms (Cestodes):

Dipylidium caninum (mature adult and immature adult)

Taenia taeniaeformis (adult)

Echinococcus multilocularis (adult)

The veterinary medicinal product is only indicated when use against nematodes and cestodes is indicated at the same time.

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Dosage

Spot-on use for external application to the skin.

Dosage and Treatment Schedule

The recommended minimum doses are 12 mg praziquantel / kg body weight and 3 mg emodepside / kg body weight, equivalent to 0.14 ml of the veterinary medicinal product / kg body weight.

To ensure a correct dosage, body weight should be determined as accurately as possible. Underdosing could result in ineffective use and may favour resistance development.

For the treatment of roundworms and tapeworms a single administration per treatment is effective.

For the treatment of queens to prevent transmission of Toxocara cati (L3 larvae) through the milk to the offspring, a single administration per treatment approximately seven days prior to expected parturition (birthing) is effective.

The need for and frequency of re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).

Method of administration

1. Remove the pipette from its packaging. Hold the pipette in an upright position, twist and pull the cap off.

2. Turn the cap around and place the other end of the cap back on the pipette. Push and twist the cap to break the seal, then remove the cap from the pipette.

3. Part the coat on the animal’s neck at the base of the skull until the skin is visible.

4. Place the tip of the pipette onto the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot. Avoid contact between the veterinary medicinal product and your fingers.

Application at the base of the skull will minimise the opportunity for the animal to lick the veterinary medicinal product off.

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Contraindications

Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.

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

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Adverse reactions

Cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Systemic disorders (anorexia, lethargy)

Digestive tract disorders (salivation, vomiting, diarrhoea)1

Neurological disorders (e.g. ataxia, tremor)1,2,3

Behavioural disorders (e.g. hyperactivity, anxiety, vocalisation)

Application site disorders (alopecia, pruritus and/or inflammation)3

1As a result of the cat licking the application site immediately after treatment.

2Mild signs.

3Transient signs.

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:

Apply only to the skin surface and on intact skin. Do not administer orally or parenterally.

Avoid the treated cat or other cats in the household licking the site of application while it is wet.

There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals. Therefore, the product should not be administered to these animals.

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

This veterinary medicinal product can be irritating to the skin and eyes. Care should be taken to avoid the contents of the pipette coming into contact with the skin, eyes and mouth, including hand-to-mouth and hand-to-eye contact.

Avoid direct contact with application area while it is wet. Keep children away from treated animals during that time.

In case of accidental contact with the skin or eyes, wash off any skin contamination immediately with soap and water.

Rinse the affected eyes thoroughly with clean, fresh water.

People with known hypersensitivity to praziquantel should avoid contact with the veterinary medicinal product.

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

Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the veterinary medicinal product.

Do not smoke, eat or drink during application.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

The solvent in this 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.

Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the WOAH, specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

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:

Can be used during pregnancy and lactation. See section 3.9.

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Interactions

Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions. The potential clinical consequences of such interactions have not been investigated. If your cat is receiving any medications, please contact your vet to discuss this before applying the product. Similarly, please inform your vet that you are using this product if s/he provides your cat with any medication.

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Overdose

Salivation, vomiting and neurological signs (tremor) were observed occasionally when the veterinary medicinal product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. These symptoms were thought to occur as a result of the cat licking the application site. The symptoms were completely reversible.

There is no known specific antidote.

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Special warnings

Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the veterinary medicinal product. Treated animals therefore should not be bathed until the solution has dried.

In the absence of the risk of co-infection with nematodes and cestodes, a narrow spectrum product should be used.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

White polypropylene pipette with a high density polyethylene closure with a spike packed in aluminum bag.

Pack sizes:

1.12 ml per pipette; cardboard box containing 1, 2, 3 or 6 pipettes.

Not all pack sizes may be marketed.

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Storage

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

Store in the original packaging (PP pipettes inserted into laminated aluminium bags) in order to protect from moisture.

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Shelf life

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

This veterinary medicinal product should not enter water courses as emodepside 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 01656/5115 (GB) Vm 01656/3115 (NI)

8 DATE OF FIRST AUTHORISATION

08 May 2025

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

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product not subject to prescription.

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

Approved 12 December 2025

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Registration holder

KRKA, d.d., Novo mesto

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