Proteq West Nile

vCP2017 virus

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Proteq West Nile?

Proteq West Nile is a vaccine that contains West Nile recombinant canarypox virus (vCP2017 virus). It is available as a suspension for injection.

What is Proteq West Nile used for?

Proteq West Nile is used to protect horses from five months of age against West Nile disease. West Nile disease is a mosquito-borne viral disease that can cause encephalitis (inflammation of the brain) and meningitis (inflammation of the lining of the brain and spinal cord). The vaccine is used to reduce the number of horses with the West Nile virus in their blood (viraemia) or with clinical signs of the disease.

The vaccine is given to young horses as two injections into the neck muscles. The first injection is given from five months of age and the second injection is given four to six weeks later. Protection starts four weeks after the first injection and lasts for a year. The horses should be revaccinated every year.

How does Proteq West Nile work?

Proteq West Nile is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The vaccine strain vCP2017 in Proteq West Nile is a ‘carrier’ canarypox virus that has been given a gene that makes it able to produce part of the West Nile virus, the proteins PreM and E. The canarypox viruses do not spread or multiply in the vaccinated horses.

When a horse is given the vaccine, the immune system recognises the West Nile proteins PreM and E as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to West Nile virus, and this helps to protect against mortality due to West Nile disease.

The vaccine also contains an ‘adjuvant’ to enhance the immune response.

How has Proteq West Nile been studied?

The vaccine was tested in nine laboratory studies in horses from five months of age. The main measure of effectiveness was based on the number of horses who had viraemia or clinical signs of West Nile disease. In all studies the vaccinated horses were compared with horses that were not vaccinated.

What benefit has Proteq West Nile shown during the studies?

The studies showed that the vaccine prevents viraemia in horses and reduces clinical signs in horses infected with West Nile virus.

What is the risk associated with Proteq West Nile?

Horses vaccinated with Proteq West Nile may have a slightly raised body temperature (up to 1.5°C) lasting up to two days. They may also have a temporary swelling at the injection site which usually disappears within four days. For a full list of the side effects reported with Proteq West Nile, see the package leaflet.

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

If someone accidentally injects themselves with the medicine, the person should seek medical advice immediately and show the package leaflet or label to the doctor.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption. The withdrawal period is zero days.

Why has Proteq West Nile been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) considered that Proteq West Nile is generally well tolerated and useful in reducing clinical outbreaks of West Nile disease. The CVMP therefore concluded that the benefits of Proteq West Nile exceed the risks for the vaccination of horses from five months of age against West Nile disease and recommended that Proteq West Nile be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Proteq West Nile

The European Commission granted a marketing authorisation valid throughout the European Union, for Proteq West Nile to Merial on 5 August 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Proteq West Nile : EPAR - Summary for the public BG = bălgarski 2011-08-15  
Proteq West Nile : EPAR - Summary for the public ES = español 2011-08-15  
Proteq West Nile : EPAR - Summary for the public CS = čeština 2011-08-15  
Proteq West Nile : EPAR - Summary for the public DA = dansk 2011-08-15  
Proteq West Nile : EPAR - Summary for the public DE = Deutsch 2011-08-15  
Proteq West Nile : EPAR - Summary for the public ET = eesti keel 2011-08-15  
Proteq West Nile : EPAR - Summary for the public EL = elliniká 2011-08-15  
Proteq West Nile : EPAR - Summary for the public EN = English 2011-08-15  
Proteq West Nile : EPAR - Summary for the public FR = français 2011-08-15  
Proteq West Nile : EPAR - Summary for the public IT = italiano 2011-08-15  
Proteq West Nile : EPAR - Summary for the public LV = latviešu valoda 2011-08-15  
Proteq West Nile : EPAR - Summary for the public LT = lietuvių kalba 2011-08-15  
Proteq West Nile : EPAR - Summary for the public HU = magyar 2011-08-15  
Proteq West Nile : EPAR - Summary for the public MT = Malti 2011-08-15  
Proteq West Nile : EPAR - Summary for the public NL = Nederlands 2011-08-15  
Proteq West Nile : EPAR - Summary for the public PL = polski 2011-08-15  
Proteq West Nile : EPAR - Summary for the public PT = português 2011-08-15  
Proteq West Nile : EPAR - Summary for the public RO = română 2011-08-15  
Proteq West Nile : EPAR - Summary for the public SK = slovenčina 2011-08-15  
Proteq West Nile : EPAR - Summary for the public SL = slovenščina 2011-08-15  
Proteq West Nile : EPAR - Summary for the public FI = suomi 2011-08-15  
Proteq West Nile : EPAR - Summary for the public SV = svenska 2011-08-15  

This EPAR was last updated on 26/05/2016 .

Authorisation details

Product details

Product details for Proteq West Nile
NameProteq West Nile
Agency product numberEMEA/V/C/002005
Active substance

vCP2017 virus

International non-proprietary name (INN) or common name

West Nile recombinant canarypox virus (vCP2017 virus)

Species Horses
Anatomical therapeutic chemical veterinary (ATCvet) codeQI05AX

Publication details

Publication details for Proteq West Nile
Marketing-authorisation holder

Merial

Revision2
Date of issue of marketing authorisation valid throughout the European Union05/08/2011

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

17/05/2016  Proteq West Nile -EMEA/V/C/002005 -R/0007

Name Language First published Last updated
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26
Proteq West Nile : EPAR - Product Information SV = svenska 2011-08-15 2016-05-26

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
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  
Proteq West Nile : EPAR - All Authorised presentations SV = svenska 2011-08-15  

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of horses from five months of age against West Nile disease by reducing the number of viraemic horses. If clinical signs are present, their duration and severity are reduced.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Proteq West Nile : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2013-01-22 2016-05-26

Initial marketing-authorisation documents

Name Language First published Last updated
Proteq West Nile : EPAR - Public assessment report SV = svenska 2011-08-15  
CVMP summary of positive opinion for Proteq West Nile SV = svenska 2011-06-10