Vepured
Authorised
This medicine is authorised for use in the European Union
E. coli verotoxoid vaccine (inactivated recombinant)
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
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.
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.
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.
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.
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.
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.
No special precautions are required.
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.
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.
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.
Product information
Latest procedure affecting product information:
IB-0005
05/11/2021
Product details
- Name of medicine
- Vepured
- 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) code
- QI09AB02
Pharmacotherapeutic group
- Immunologicals for suidae
- Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium
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.
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