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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/479129/2010

EMEA/V/C/000076

EPAR summary for the public

Advocate

Imidacloprid / moxidectin

This is a summary of the European Public Assessment Report (EPAR). It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Advocate.

For practical information about using Advocate, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Advocate and what is it used for?

Advocate is a medicine used on cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections (caused by several different types of parasites):

•    for the treatment and prevention of flea infestations in cats, ferrets and dogs

•    as part of treatment strategies for flea allergy dermatitis (an allergic reaction to flea bites) in cats and dogs

•    for the treatment of ear mite infestations in cats and dogs

•    for the treatment of notoedric mange in cats

•    for the treatment of biting lice infestations in dogs

•    for the treatment of skin diseases in dogs caused by parasitic mites (sarcoptic mange and demodicosis)

•    for the prevention of heartworm disease in cats, ferrets and dogs

•    for the prevention and treatment of dirofilariosis (infection with the heartworms Dirofiiaria immitis and Dirofiiaria repens) in dogs.

•    for the prevention and treatment of lungworm in dogs

•    for the prevention of spirocercosis (a worm infection affecting the gullet) in dogs

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• for the treatment of infections with certain (as specified in the package leaflet) gastrointestinal roundworms in cats and dogs.

It contains two active substances, imidacloprid and moxidectin.

How is Advocate used?

Advocate is available as a spot-on solution and comes in different strengths and pack sizes, depending on whether it is for use on cats, on ferrets, or on dogs, and on the size of the animal being treated.

The medicine can only be obtained with a prescription. Advocate is applied to cats, ferrets and dogs from pre-filled pipettes. These are small plastic droppers, available in different sizes depending on the size of the animal, which are filled with the correct amount of Advocate for one treatment. The content of a full pipette is applied onto the animal's skin, after parting the fur. In cats and ferrets, the product is applied to the animal's neck at the base of the skull. In dogs it is applied between the shoulder blades at the bottom of the dog's head, but for large dogs (above 25 kg) the product should be applied in 3 or 4 spots along the dog's back, whilst it is standing, from between its shoulder blades to the base of its tail.

The dose and frequency of application depends on why Advocate is being used and whether it is used in cats, ferrets or dogs; the package leaflet includes detailed information on dosage and duration of treatment.

How does Advocate work?

Imidacloprid interferes with certain specific receptors (nicotinergic acetylcholine receptors) in the nervous systems of lice and fleas, which results in their subsequent paralysis and death.

Moxidectin causes paralysis and death of nematodes and heartworms by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.

How has Advocate been studied?

The effectiveness of the products against the specified parasites was investigated in laboratory studies. Subsequently the efficacy was confirmed in several field studies in cats and dogs, which were conducted in several different European geographical locations. Cats and dogs from various breeds, age groups and weights were treated. Field studies involving heartworm in dogs were conducted both in the USA and Europe. The effectiveness of the product was measured by looking at the number of live parasites at various times after treatment. Efficacy studies were also performed in ferrets.

What benefits of Advocate have been shown during the studies?

The results of the laboratory and field trials in cats, ferrets and dogs showed that Advocate is effective, when used as detailed in the package leaflet (see "What is Advocate used for?" above, or for more details see the package leaflet).

What are the risks associated with Advocate?

In both cats and dogs the most common side effects are local reactions at the site of application, such as temporary itchiness, and on rare occasions, greasy fur and redness of the skin. Vomiting has also occurred rarely. These signs disappear without further treatment. If a cat or dog licks the application area, it might salivate for a short period and might show signs such as a lack of muscular coordination, shaking, abnormal breathing and/or vomiting.

Advocate

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Although no side effects have been confirmed in ferrets, similar side effects could occur rarely.

Dogs and cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should only be treated after special consideration by the veterinarian.

Advocate should not be used in kittens under 9 weeks of age or in puppies under 7 weeks of age.

Advocate should not be used in dogs classified as Class 4 for heartworm disease.

Advocate comes in different strengths and different pipette sizes depending on whether it is for use on cats, ferrets or dogs. It is very important that the cat products should only be used for cats, and the dog products for dogs. Only the product called "Advocate spot-on solution for small cats and ferrets" should be used for ferrets. Advocate should not be used for any other animal species.

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

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Skin contact with the pipette contents should be avoided and animals should not be stroked or groomed until the application site is dry. When administering Advocate, the user should not smoke, eat or drink, and should wash their hands thoroughly after use. If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.

People with a known sensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.

The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.

Why is Advocate approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Advocate's benefits are greater than its risks and recommended that Advocate be approved for use in the EU.

Other information about Advocate

The European Commission granted a marketing authorisation valid throughout the EU for Advocate on 2 April 2003.

The full EPAR for Advocate can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Advocate, animal owners of keepers should read the package leaflet or contact their veterinarian or pharmacist.

This summary was last updated in July 2015.

Advocate

EMA/479129/2010