Ecoporc Shiga

genetically modified recombinant Shiga-toxin-2e antigen

  • Email
  • Help

About

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 document 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 Ecoporc Shiga?

Ecoporc Shiga is a vaccine containing a form of Shiga toxin (Stx2e) that has been modified so that it can no longer cause disease.

What is Ecoporc Shiga used for?

Ecoporc Shiga is used in pigs from the age of four days for active immunisation against oedema disease, which leads to fluids accumulating in the tissues of the stomach and gut. Damage to the wall of small blood vessels in the brain results in characteristic nervous signs. It is caused by a bacterial toxin (poison) known as Shiga toxin 2e (Stx2e) that is produced by certain strains of Escherichia coli. Oedema disease is found worldwide and usually occurs in the first two weeks after weaning of the piglets, and is an acute (short-term) condition which can lead to death within 24 to 48 hours.

The vaccine is given as a single injection into a muscle, preferably the neck muscle behind the ear. Protection starts 21 days after vaccination and lasts for 105 days.

How does Ecoporc Shiga work?

Ecoporc Shiga is a vaccine containing the modified toxin Stx2e. When Ecoporc Shiga 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, the immune system will be able to make antibodies against it more quickly. This will help protect against the disease.

Ecoporc Shiga contains an adjuvant (aluminium hydroxide) to enhance the immune response.

The modified toxin in the vaccine is produced by a method known as ‘recombinant DNA technology’: it is made by bacteria which have received a gene (DNA) that makes them produce the modified toxin.

How has Ecoporc Shiga been studied?

The effectiveness of the vaccine was first studied in a number of laboratory studies in piglets. The purpose of the studies was to establish how long it took for piglets to be fully protected, the length of time protection lasts against oedema disease as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.

Three field trials were also performed to assess the effect on mortality and clinical signs of oedema disease in a total of 518 piglets receiving Ecoporc Shiga compared with a similar number of piglets receiving placebo (a dummy injection).

What benefit has Ecoporc Shiga shown during the studies?

The laboratory studies showed that the injection had its full effect by 21 days, and that protection lasted for at least 105 days after injection. Protection was not affected by antibodies transmitted from the mother. The field studies showed that the vaccine reduced the mortality and clinical signs of oedema disease compared with placebo: in all three studies no piglets receiving Ecoporc Shiga died, while up to 11% of piglets receiving placebo died.

What is the risk associated with Ecoporc Shiga?

The most common side effects after injection of Ecoporc Shiga (which may affect up to 1 in 10 animals) are mild swelling, lasting for up to seven days, at the injection site and a slight rise in body temperature for up to two days after injection. Both resolve without treatment.

For a full list of all side effects reported with Ecoporc Shiga, see the package leaflet.

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

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown 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 for Ecoporc Shiga is zero days.

Why has Ecoporc Shiga been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ecoporc Shiga exceed the risks for the approved indications and recommended that Ecoporc Shiga be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Ecoporc Shiga:

The European Commission granted a marketing authorisation valid throughout the European Union, for Ecoporc Shiga on 10 April 2013. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Ecoporc Shiga : EPAR - Summary for the public BG = bălgarski 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public ES = español 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public CS = čeština 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public DA = dansk 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public DE = Deutsch 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public ET = eesti keel 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public EL = elliniká 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public EN = English 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public FR = français 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public IT = italiano 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public LV = latviešu valoda 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public LT = lietuvių kalba 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public HU = magyar 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public MT = Malti 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public NL = Nederlands 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public PL = polski 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public PT = português 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public RO = română 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public SK = slovenčina 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public SL = slovenščina 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public FI = suomi 2013-05-16  
Ecoporc Shiga : EPAR - Summary for the public SV = svenska 2013-05-16  

This EPAR was last updated on 14/04/2015 .

Authorisation details

Product details

Product details for Ecoporc Shiga
NameEcoporc Shiga
Agency product numberEMEA/V/C/002588
Active substance

genetically modified recombinant Shiga-toxin-2e antigen

International non-proprietary name (INN) or common name

genetically modified Shiga-toxin-2e antigen

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codeQI09AB02

Publication details

Publication details for Ecoporc Shiga
Marketing-authorisation holder

IDT Biologika GmbH

Revision2
Date of issue of marketing authorisation valid throughout the European Union10/04/2013

Contact address:

IDT Biologika GmbH
Am Pharmapark
D-06861 Dessau-Rosslau
Germany

Product information

Product information

01/04/2015  Ecoporc Shiga -EMEA/V/C/002588 -IB/0003

Name Language First published Last updated
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14
Ecoporc Shiga : EPAR - Product Information SV = svenska 2013-05-16 2015-04-14

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
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  
Ecoporc Shiga : EPAR - All Authorised presentations SV = svenska 2013-05-16  

Pharmacotherapeutic group

Immunologicals for suidae, inactivated bacterial vaccines

Therapeutic indication

Active immunisation of piglets from the age of four days, to reduce the mortality and clinical signs of oedema disease caused by Shiga toxin 2e produced by Escherichia coli (STEC).

Onset of immunity: 21 days after vaccination.

Duration of immunity: 105 days after vaccination.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ecoporc Shiga : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2014-05-21 2015-04-14

Initial marketing-authorisation documents

Name Language First published Last updated
Ecoporc Shiga : EPAR - Public assessment report SV = svenska 2013-05-16  
CVMP summary of positive opinion for Ecoporc Shiga SV = svenska 2013-02-08