Coliprotec F4/F18

Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)

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This is a summary of the European public assessment report (EPAR) for Coliprotec F4/F18. 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 Coliprotec F4/F18.

For practical information about using Coliprotec F4/F18, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Coliprotec F4/F18 and what is it used for?

Coliprotec F4/F18 is a vaccine used to protect pigs from 18 days of age against post-weaning diarrhoea caused by E. coli. Although E. coli bacteria are naturally found in the gut, some strains (known as enterotoxigenic strains) produce toxins that cause diarrhoea and can result in dehydration, weight loss and occasionally death of the animal. This is more likely to occur at weaning time when the piglet no longer receives protecting antibodies through the sow’s milk.

Coliprotec F4/F18 contains two strains of live E. coli bacteria (O8:K87 and O141:K94) which do not produce toxins that cause disease.

How is Coliprotec F4/F18 used?

Coliprotec F4/F18 is available as a lyophilisate (a freeze-dried pellet) which is made up into a suspension with water to be given by mouth.

Coliprotec F4/F18 is given by mouth to pigs as a single dose either as a drench or by addition to the drinking water. The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination. The medicine can only be obtained with a prescription.

For further information, see the package leaflet.

How does Coliprotec F4/F18 work?

Coliprotec F4/F18 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The types of E. coli associated with post-weaning diarrhoea often produce proteins called F4 and F18 on their outer coat that allows them to attach to the cells of the gut. The strains of bacteria in the vaccine have these proteins but do not produce the toxins that cause the disease.

When Coliprotec F4/F18 is given to pigs, the animals’ immune system recognises the bacteria as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to disease-causing bacteria with the F4 or F18 proteins, the immune system will be able to respond more quickly. This will help protect the pigs against the infection and reduce the risk of disease.

What benefits of Coliprotec F4/F18 have been shown in studies?

The effectiveness of the vaccine was studied in four laboratory studies in pigs that looked chiefly at the incidence, severity and duration of diarrhoea as well as the presence of disease-causing E. coli in the animals’ excrement. Pigs aged 17 – 18 days were vaccinated with Coliprotec F4/F18 and then artificially infected with E. coli strains. Two studies used the F4 strain while the other two used the F18 strain. The vaccine reduced the number of pigs with moderate to severe diarrhoea compared to non-vaccinated pigs. Two studies showed the vaccine starts to be effective 7 days after vaccination and two studies showed protection lasts for 21 days after vaccination.

What are the risks associated with Coliprotec F4/F18?

There are currently no known side effects associated with Coliprotec F4/F18.

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

Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.

In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or label shown to the doctor. In case of spillage onto skin, the affected area should be rinsed with water and medical advice should be sought immediately and the package leaflet or label shown to the doctor.

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 Coliprotec F4/F18 is ‘zero’ days, which means there is no mandatory waiting time.

Why is Coliprotec F4/F18 approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Coliprotec F4/F18’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Coliprotec F4/F18?

The European Commission granted a marketing authorisation valid throughout the EU for Coliprotec F4/F18 on 9 January 2017.

For more information about treatment with Coliprotec F4/F18, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Coliprotec F4/F18 : EPAR - Summary for the public BG = bălgarski 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public ES = español 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public CS = čeština 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public DA = dansk 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public DE = Deutsch 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public ET = eesti keel 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public EL = elliniká 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public EN = English 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public FR = français 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public IT = italiano 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public LV = latviešu valoda 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public LT = lietuvių kalba 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public HU = magyar 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public MT = Malti 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public NL = Nederlands 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public PL = polski 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public PT = português 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public RO = română 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public SK = slovenčina 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public SL = slovenščina 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public FI = suomi 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public SV = svenska 2017-02-06  
Coliprotec F4/F18 : EPAR - Summary for the public HR = Hrvatski 2017-02-06  

This EPAR was last updated on 06/02/2017 .

Authorisation details

Product details

Product details for Coliprotec F4/F18
NameColiprotec F4/F18
Agency product numberEMEA/V/C/004225
Active substance

Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)

International non-proprietary name (INN) or common name

Porcine post-weaning diarrhoea vaccine (live)

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AE03


Publication details

Publication details for Coliprotec F4/F18
Marketing-authorisation holder

Prevtec Microbia GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/01/2017

Contact address:

Prevtec Microbia GmbH
Geyerspergerstrasse 27
D-80689 Munchen
Germany

Product information

Product information

09/01/2017  Coliprotec F4/F18 -EMEA/V/C/004225

Name Language First published Last updated
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - Product Information HR = Hrvatski 2017-02-06  

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
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  
Coliprotec F4/F18 : EPAR - All Authorised presentations HR = Hrvatski 2017-02-06  

Pharmacotherapeutic group

Immunologicals for suidae; Live bacterial vaccines

Therapeutic indication

For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18-positive Escherichia coli in order to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) in infected pigs and to reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Coliprotec F4/F18 : EPAR - Public assessment report HR = Hrvatski 2017-02-06  
CVMP summary of positive opinion for Coliprotec F4/F18 HR = Hrvatski 2016-11-11  

Authorised

This medicine is approved for use in the European Union