Coliprotec F4 (live non-pathogenic Escherichia coli...) - QI09AE03
Updated on site: 09-Feb-2018
|Medication name:||Coliprotec F4|
|Substance:||live non-pathogenic Escherichia coli O8:K87|
|Manufacturer:||Prevtec Microbia GmbH|
- What is Coliprotec F4?
- How does Coliprotec F4 work?
- How has Coliprotec F4 been studied?
- What benefit has Coliprotec F4 shown during the studies?
- What is the risk associated with Coliprotec F4?
- What are the precautions for the person who gives the medicine or comes into contact with the animal?
- What is the withdrawal period?
- Why has Coliprotec F4 been approved?
E. coli O8:K87 vaccine (live)
This is a summary of the European public assessment report. 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
What is Coliprotec F4?
Coliprotec F4 is a vaccine that is available as a lyophilisate (a
What is Coliprotec F4 used for?
Coliprotec F4 is given to pigs from 18 days of age to reduce the incidence of moderate to severe
Coliprotec F4 is given orally 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.
How does Coliprotec F4 work?
Coliprotec F4 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
How has Coliprotec F4 been studied?
The effectiveness of the vaccine was first studied in a number of laboratory studies in pigs. The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against E. coli.
The effectiveness of Coliprotec F4 was investigated in two field studies involving pigs where the farms had a history of
What benefit has Coliprotec F4 shown during the studies?
Both field studies showed that vaccination with Coliprotec F4 reduced the number of pigs with moderate to severe diarrhoea.
What is the risk associated with Coliprotec F4?
Shivering may be seen in more than 1 in 10 pigs after vaccination.
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 and/or spillage onto skin, medical advice should be sought immediately and the package leaflet or the 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.
The withdrawal period for Coliprotec F4 for pigs is zero days.
Why has Coliprotec F4 been approved?
The CVMP concluded that the benefits of Coliprotec F4 exceed the risks for the approved indication and recommended that Coliprotec F4 be given a marketing authorisation. The
Other information about Coliprotec F4:
The European Commission granted a marketing authorisation valid throughout the European Union, for Coliprotec F4 on 16 March 2015. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in January 2015.