Porcilis ColiClos

Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT

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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 Porcilis ColiClos?

Porcilis ColiClos is a vaccine that is available as a suspension for injection. It contains parts of the Escherichia coli (E. coli) bacterium called fimbrial adhesins F4ab, F4ac, F5 and F6 and LT toxoid (weakened toxin), as well as toxoid of the Clostridium perfringens (C. perfringens) bacterium type C.

What is Porcilis ColiClos used for?

Porcilis ColiClosis is given to sows (female pigs that have already given birth to piglets) or gilts (female pigs that have not yet given birth to piglets) to provide their offspring with protection against infections caused by E. coli strains that express the components F4ab, F4ac, F5 or F6, and by C. perfringens type C. The vaccine is used to reduce death and clinical signs of infections caused by these bacteria during the first days of life.

Porcilis ColiClos is given by injection into a muscle in the neck area behind the ear. The first injection is given to sows or gilts, six or eight weeks before the expected farrowing (giving-birth) date and a second injection is given four weeks later. Sows that have been vaccinated according to this scheme before need a single revaccination two to four weeks before the expected farrowing date.

How does Porcilis ColiClos work?

Porcilis ColiClos is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Porcilis ColiClos contains parts of the bacteria E. coli and C. perfringens that have been inactivated so that they cannot cause disease. When Porcilis ColiClos is given to sows or gilts, the pigs' immune systems recognise the inactivated bacteria as ‘foreign’ and make antibodies against them. These antibodies are transferred from the mothers to their piglets through the colostrum (first milk), and they help the piglets to fight E. coli or C. perfringens infection if they become exposed after birth.

Porcilis ColiClos contains an adjuvant to enhance the immune response.

How has Porcilis ColiClos been studied?

The company has presented data from both laboratory and field studies on the effectiveness of the vaccine against the two bacteria. To demonstrate protection against E.coli infection, studies were also presented with Porcilis Porcoli Diluvac Forte, a vaccine authorised within the European Union with the same E. coli components as Porcilis ColiClos.

What benefit has Porcilis ColiClos shown during the studies?

Porcilis ColiClos has been shown to reduce death and the clinical signs of E. coli or C. perfringens infections such as neonatal-piglet diarrhoea and necrotic enterotoxaemia (a severe infection of the intestines). It may also reduce the use of antimicrobials in pig-production units.

What is the risk associated with Porcilis ColiClos?

An increase in body temperature of up to 2°C may be observed on the day of vaccination. Reduced activity and lack of appetite on the day of vaccination commonly occurs. A sometimes painful and hard swelling up to 10 cm in diameter may be observed at the injection site for up to 25 days.

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 the label shown to the physician.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine 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 Porcilis ColiClos is zero days for pig meat.

Why has Porcilis ColiClos been approved?

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

Other information about Porcilis ColiClos:

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis ColiClos on 14 June 2012. Information on the prescription status of this product can be found on the label / outer package.

Name Language First published Last updated
Porcilis ColiClos : EPAR - Summary for the public BG = bălgarski 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public ES = español 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public CS = čeština 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public DA = dansk 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public DE = Deutsch 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public ET = eesti keel 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public EL = elliniká 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public EN = English 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public FR = français 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public IT = italiano 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public LV = latviešu valoda 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public LT = lietuvių kalba 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public HU = magyar 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public MT = Malti 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public NL = Nederlands 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public PL = polski 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public PT = português 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public RO = română 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public SK = slovenčina 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public SL = slovenščina 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public FI = suomi 2013-06-13  
Porcilis ColiClos : EPAR - Summary for the public SV = svenska 2013-06-13  

This EPAR was last updated on 28/04/2017 .

Authorisation details

Product details

Product details for Porcilis ColiClos
NamePorcilis ColiClos
Agency product numberEMEA/V/C/002011
Active substance

Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT

International non-proprietary name (INN) or common name

vaccine to provide passive immunity to the progeny against Escherichia coli in pigs

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AB08


Publication details

Publication details for Porcilis ColiClos
Marketing-authorisation holder

Intervet International BV

Revision3
Date of issue of marketing authorisation valid throughout the European Union14/06/2012

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

Product information

Product information

23/03/2017  Porcilis ColiClos -EMEA/V/C/002011 -R/0006

Name Language First published Last updated
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28
Porcilis ColiClos : EPAR - Product Information SV = svenska 2013-06-13 2017-04-28

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
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05
Porcilis ColiClos : EPAR - All Authorised presentations SV = svenska 2013-06-13 2015-08-05

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those Escherichia coli strains which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by Clostridium perfringens type C.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Porcilis ColiClos : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2014-04-14 2017-04-28

Initial marketing-authorisation documents

Name Language First published Last updated
Porcilis ColiClos : EPAR - Public assessment report SV = svenska 2013-06-13  
CVMP summary of positive opinion for Porcilis ColiClos SV = svenska 2012-04-16