Overview

Felisecto Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that can enter and infect the body. The medicine can be used:

  • to treat tick infestations

  • to treat and prevent flea infestations. It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)

  • to treat ear mites

  • to treat biting lice infestations

  • to treat adult roundworms and adult hookworms in the gut

  • to prevent heartworm disease

Felisecto Plus must only be used when there is a need to treat ticks and one or more of the above parasites. Felisecto Plus contains two active substances, selamectin and sarolaner.

For more information, see the package leaflet.

This medicine is the same as Stronghold Plus, which is already authorised in the European Union (EU). The company that makes Stronghold Plus has agreed that its scientific data can be used for Felisecto Plus (‘informed consent’).

Felisecto Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription. The content of the pipette is squeezed onto the skin after parting the fur at the base of the cat’s neck in front of the shoulder blades. This small volume of liquid is absorbed through the skin and has an effect throughout the animal’s body. The strength and number of pipettes used depends on the weight of the cat being treated.

Felisecto Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).

For more information about using Felisecto Plus, see the package leaflet or contact your veterinarian or pharmacist.

Felisecto Plus contains selamectin and sarolaner, which are antiparasitic medicines.

Selamectin activates special proteins called ‘chloride channels’ on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity. This causes the paralysis or death of the parasites. Selamectin is effective against fleas, ear mites, biting lice, heartworm larvae, roundworms and hookworms.

Sarolaner blocks the normal movement of charged chloride particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters). This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites. Sarolaner is effective against ticks and fleas.

In order to be exposed to selamectin and sarolaner, fleas and ticks must commence feeding on the cat’s blood.

The effectiveness of Felisecto Plus was investigated in a field study in cats naturally infested with fleas. Cats were treated with Felisecto Plus monthly for 3 months or another similar antiparasitic medicine, containing imidacloprid and moxidectin. Felisecto Plus was as effective as the other medicine and reduced flea counts by more than 95%.

A second field study was conducted in cats naturally infested with ticks. Cats were treated with Felisecto Plus monthly for 3 months or another medicine, containing fipronil. Felisecto Plus was as effective as the other medicine and reduced tick counts by more than 90%.

Two laboratory studies with cats artificially infested with ear mites showed Felisecto Plus to reduce ear mites by more than 90% 30 days after a single treatment.

A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.

Two laboratory studies were conducted in cats with intestinal worms which showed Felisecto Plus to have more than 94% effectiveness.

A laboratory study with cats artificially infected with heartworm showed Felisecto Plus to be effective for the prevention of heartworm disease.

Use of the medicine may result in mild and short-lived itching at the application site.

The most common side effects with Felisecto Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling.

Felisecto Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).

Because ticks must start feeding on the cat in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.

For the full list of restrictions, see the package leaflet.

Safety information has been included in the summary of product characteristics and the package leaflet for Felisecto Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

Felisecto Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.

Hands should be washed after use and any product in contact with the skin should be washed off immediately with soap and water.

People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Felisecto Plus with caution.

Felisecto Plus is harmful after swallowing. The medicine must be kept in its packaging until use, in order to prevent access by children. Used pipettes of the medicine must be disposed of immediately. If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.

Treated animals must not be touched until the application area is dry. Children must not be allowed to play with treated cats for 4 hours after treatment. It is recommended to treat cats in the evening. On the day of treatment, treated cats must not be allowed to sleep in the same bed as their owner, especially children.

In case of skin or eye contact, the affected area should be rinsed immediately with water.

The European Medicines Agency decided that Felisecto Plus’s benefits are greater than its risks and it can be authorised for use in the EU.

Felisecto Plus received a marketing authorisation valid throughout the EU on 26 April 2019.

This authorisation was based on the authorisation granted to Stronghold Plus in 2017 (‘informed consent’).

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Latest procedure affecting product information: IB/0004

11/06/2021

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Product details

Name of medicine
Felisecto Plus
Active substance
  • selamectin
  • sarolaner
International non-proprietary name (INN) or common name
  • selamectin
  • sarolaner
Species
Cats
Anatomical therapeutic chemical veterinary (ATCvet) code
QP54AA55

Pharmacotherapeutic group

Antiparasitic products, insecticides and repellents

Therapeutic indication

For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time.

Authorisation details

EMA product number
EMEA/V/C/005093
Marketing authorisation holder
Zoetis Belgium SA

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Opinion adopted
21/02/2019
Marketing authorisation issued
26/04/2019
Revision
2

Assessment history

Topics

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