Vepured

recombinant Verotoxin 2e of E. coli

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This is a summary of the European public assessment report (EPAR) for Vepured.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 Vepured.

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

What is Vepured and what is it used for?

Vepured is a veterinary vaccine used to protect piglets against oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain until slaughter. Oedema disease is caused by a bacterial toxin (poison) known as verotoxin 2e that is produced by certain strains of Escherichia coli. It results in damage to blood vessels, causing fluid build up in the tissues of the stomach and bowel and affecting the blood supply of the brain, and can lead to death within 24 to 48 hours. Oedema disease is found worldwide and usually occurs in the first few weeks of life of the piglets.

Vepured contains verotoxin 2e that has been modified and inactivated so it can no longer cause disease.

How is Vepured used?

Vepured is available as a suspension for injection and can only be obtained with a prescription. Vepured is given to piglets from 2 days of age as a single injection into the muscle in the neck. Protection starts 21 days after vaccination and lasts for 112 days.

How does Vepured work?

Vepured is a vaccine containing modified, inactivated verotoxin 2e. When Vepured is given to pigs, the animal’s immune system recognises the toxin contained in the vaccine as ‘foreign’ and makes antibodies against it. In the future, if the animals are exposed to the bacteria producing the unmodified toxin, their immune system will be able to make antibodies against the toxin more quickly. This will help protect against the disease.

Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.

What benefits of Vepured have been shown in studies?

A field study involving 2- to 3-day-old piglets, 1,173 of which were vaccinated with Vepured and 1,048 piglets given a dummy injection, showed that Vepured prevented death of virtually all the piglets from oedema disease over a 115 day period and there was a significant reduction in signs of the disease which included difficulty breathing, oedema (fluid retention) and signs related to the nervous system. Vepured also reduced the weight loss of pigs in herds affected with the disease.

What are the risks associated with Vepured?

The most common side effects with Vepured (which may affect more than 1 in 10 animals) are mild inflammation at the injection site that resolves within 3 days of vaccination without treatment, mild depression on the day of vaccination and an increase in body temperature of maximum 1.1 °C which returns to normal within 1 day.

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?

No special precautions are required.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from pigs treated with Vepured is ‘zero’ days, which means there is no mandatory waiting time.

Why is Vepured approved?

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

Other information about Vepured

The European Commission granted a marketing authorisation valid throughout the EU for Vepured on 17 August 2017.

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

Name Language First published Last updated
Vepured : EPAR - Summary for the public BG = bălgarski 2017-09-18  
Vepured : EPAR - Summary for the public ES = español 2017-09-18  
Vepured : EPAR - Summary for the public CS = čeština 2017-09-18  
Vepured : EPAR - Summary for the public DA = dansk 2017-09-18  
Vepured : EPAR - Summary for the public DE = Deutsch 2017-09-18  
Vepured : EPAR - Summary for the public ET = eesti keel 2017-09-18  
Vepured : EPAR - Summary for the public EL = elliniká 2017-09-18  
Vepured : EPAR - Summary for the public EN = English 2017-09-18  
Vepured : EPAR - Summary for the public FR = français 2017-09-18  
Vepured : EPAR - Summary for the public IT = italiano 2017-09-18  
Vepured : EPAR - Summary for the public LV = latviešu valoda 2017-09-18  
Vepured : EPAR - Summary for the public LT = lietuvių kalba 2017-09-18  
Vepured : EPAR - Summary for the public HU = magyar 2017-09-18  
Vepured : EPAR - Summary for the public MT = Malti 2017-09-18  
Vepured : EPAR - Summary for the public NL = Nederlands 2017-09-18  
Vepured : EPAR - Summary for the public PL = polski 2017-09-18  
Vepured : EPAR - Summary for the public PT = português 2017-09-18  
Vepured : EPAR - Summary for the public RO = română 2017-09-18  
Vepured : EPAR - Summary for the public SK = slovenčina 2017-09-18  
Vepured : EPAR - Summary for the public SL = slovenščina 2017-09-18  
Vepured : EPAR - Summary for the public FI = suomi 2017-09-18  
Vepured : EPAR - Summary for the public SV = svenska 2017-09-18  
Vepured : EPAR - Summary for the public HR = Hrvatski 2017-09-18  

This EPAR was last updated on 18/09/2017 .

Authorisation details

Product details

Product details for Vepured
NameVepured
Agency product numberEMEA/V/C/004364
Active substance

recombinant Verotoxin 2e of E. coli

International non-proprietary name (INN) or common name

E. coli verotoxoid vaccine (inactivated recombinant)

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AB02


Publication details

Publication details for Vepured
Marketing-authorisation holder

Laboratorios Hipra, S.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union17/08/2017

Contact address:

Laboratorios Hipra, S.A.
Avda. La Selva 135
17170 Amer (Girona) 
Spain

Product information

Product information

17/08/2017  Vepured -EMEA/V/C/004364

Name Language First published Last updated
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  
Vepured : EPAR - Product Information HR = Hrvatski 2017-09-18  

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
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27
Vepured : EPAR - All Authorised presentations HR = Hrvatski 2017-09-18 2017-09-27

Pharmacotherapeutic group

Immunologicals for Suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia).

Therapeutic indication

Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Vepured : EPAR - Public assessment report HR = Hrvatski 2017-09-18  
CVMP summary of positive opinion for Vepured HR = Hrvatski 2017-06-16  

Authorised

This medicine is approved for use in the European Union