Praziquantel/Emodepside Krka Worming Spot-on Solution 60 mg/15 mg for Medium Cats

Each 0.70 ml pipette contains:
Active substances:
Praziquantel 60 mg
Emodepside 15 mg
Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Butylhydroxyanisole (E320)3.78 mg Isopropylidene glycerolLactic acid
Clear, colourless to yellow or to brown solution.
3. CLINICAL INFORMATION
3.1 Target species
Medium cats (greater than 2.5 – 5 kg).
3.2 Indications for use for each target species
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.
3.3 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.
3.4 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.
3.5 Special precautions for use
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.
3.6 Adverse events
Cats:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Systemic disorders (anorexia, lethargy)
Digestive tract disorders (salivation, vomiting,
diarrhoea)
Neurological disorders (e.g. ataxia, tremor)
1,2,3
Behavioural disorders (e.g. hyperactivity, anxiety,
vocalisation)
Application site disorders (alopecia, pruritus
and/or inflammation)
1
As a result of the cat licking the application site immediately after treatment.
Mild signs.
Transient 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.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation. See section 3.9.
3.8 Interaction with other medicinal products and other forms of interaction
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.
3.9 Administration routes and 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.
Body weight
of the cat
(kg)
Pipette size/volume
(ml) to be used
Praziquantel (mg/kg
body weight)
Emodepside (mg/kg
body weight)
Equal
to/greater
than 0.5-2.5
0.3512 – 603 – 15Greater
than 2.5-5
0.7012 – 243 – 6Greater
than 5-8
1.1212 – 19.23 – 4.8Greater
than 8
Use an appropriate combination of pipettes.
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.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
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.
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.
3.12 Withdrawal periods
Not applicable.
4.