Advocate

imidacloprid / moxidectin

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About

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 Dirofilaria immitis and Dirofilaria 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
  • 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?

a, it might salivate for a short period and might show signs such as a lack of muscular co-ordination, shaking, abnormal breathing and/or vomiting.

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.

 For more information about treatment with Advocate, animal owners of keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Advocate : EPAR - Summary for the public BG = bălgarski 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public ES = español 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public CS = čeština 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public DA = dansk 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public DE = Deutsch 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public ET = eesti keel 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public EL = elliniká 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public EN = English 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public FR = français 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public IT = italiano 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public LV = latviešu valoda 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public LT = lietuvių kalba 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public HU = magyar 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public MT = Malti 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public NL = Nederlands 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public PL = polski 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public PT = português 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public RO = română 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public SK = slovenčina 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public SL = slovenščina 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public FI = suomi 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public SV = svenska 27/07/2009 21/10/2015
Advocate : EPAR - Summary for the public HR = Hrvatski 27/07/2009 21/10/2015

This EPAR was last updated on 20/06/2016 .

Authorisation details

Product details

Product details for Advocate
NameAdvocate
Agency product numberEMEA/V/C/000076
Active substance

imidacloprid / moxidectin

International non-proprietary name (INN) or common name

imidacloprid / moxidectin

Species FerretsDogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codeQP54AB52

Publication details

Publication details for Advocate
Marketing-authorisation holder

Bayer Animal Health GmbH

Revision15
Date of issue of marketing authorisation valid throughout the European Union02/04/2003

Contact address:

Bayer Animal Health GmbH
51368 Leverkusen
Germany

Product information

Product information

09/06/2016  Advocate -EMEA/V/C/000076 -IAIN/0032

Name Language First published Last updated
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016
Advocate : EPAR - Product Information HR = Hrvatski 27/07/2009 20/06/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013
Advocate : EPAR - All Authorised presentations HR = Hrvatski 27/07/2009 18/01/2013

Pharmacotherapeutic group

Endectocides

Therapeutic indication

Dogs

For dogs suffering from, or at risk from, mixed parasitic infections:

  • For the treatment and prevention of flea infestation (Ctenocephalides felis),
  • the treatment of biting lice (Trichodectes canis),
  • the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis),
  • the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
  • the treatment of circulating microfilariae (Dirofilaria immitis),
  • the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens)
  • the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),
  • the reduction of circulating microfilariae (Dirofilaria repens),
  • the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),
  • the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
  • the prevention of spirocercosis (Spirocerca lupi),
  • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).

The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Cats

For cats suffering from, or at risk from, mixed parasitic infections:

  • For the treatment and prevention of flea infestation (Ctenocephalides felis),
  • the treatment of ear mite infestation (Otodectes cynotis),
  • the treatment of notoedric mange (Notoedres cati),
  • the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
  • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).

The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Ferrets

For ferrets suffering from, or at risk from, mixed parasitic infections: 

  • For the treatment and prevention of flea infestation (Ctenocephalides felis),
  • the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Advocate : EPAR - Procedural steps taken before authorisation HR = Hrvatski 27/07/2009  
Advocate : EPAR - Scientific Discussion HR = Hrvatski 27/07/2009