Enteroporc Coli AC
Authorised
This medicine is authorised for use in the European Union
neonatal piglet colibacillosis (recombinant, inactivated) / Clostridium perfringens vaccine (inactivated)
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Enteroporc Coli AC is a veterinary vaccine 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 protect their offspring from intestinal disease caused by the bacteria Escherichia coli (E. coli) and Clostridium perfringens (C. perfringens)types A and C. It contains parts of the E. coli bacterium called fimbrial adhesins F4ab, F4ac, F5 and F6 and of the C. perfringens bacterium called alfa, beta1 and beta2 toxoids (inactivated toxins).
Enteroporc Coli AC can only be obtained with a prescription and is available as an injection. It is given into the neck muscles in the area behind the ear of female pregnant pigs. The initial vaccination course is two injections given 3 weeks apart, with the second injection given 2 weeks before farrowing (giving birth). In each following pregnancy, sows that have previously been vaccinated according to this schedule should be given a single revaccination two weeks before the expected farrowing date.
Enteroporc Coli AC is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Enteroporc Coli AC contains parts of the bacteria E. coli and C. perfringens that have been inactivated so that they cannot cause disease. When Enteroporc Coli AC is given to sows or gilts, the pig’s immune system recognises the inactivated bacterial parts as ‘foreign’ and makes antibodies against them. These antibodies are transferred from the mother to the piglets through the colostrum (first milk), and they help the piglets to fight E. coli or C. perfringens infections if they become exposed after birth. Protection of the progeny starts within 12 hours (against E. coli) or 24 hours (against C. perfringens) after birth and lasts for the first days of life (against E.coli), 14 days of life (against C. perfringens type A) and 21 days of life (against C. perfringens type C). Enteroporc Coli AC also contains the adjuvant (ingredient that strengthens the immune response) aluminium hydroxide.
Enteroporc Coli AC 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).
Six laboratory studies conducted in newborn piglets showed protection began within 12 hours (E. coli) or during the first day of life (C. perfringens) and lasted for the first days of life (E. coli) or for 14 to 21 days (C. perfringens). In addition, three laboratory studies conducted in sows confirmed the effectiveness after revaccination, as determined by the levels of antibodies in colostrum.
Data from three field studies were presented in support of the results of the laboratory studies where efficacy was determined by antibody titres in colostrum of the vaccinated sows.
The most common side effects with Enteroporc Coli AC (which may affect more than 1 in 10 animals) are an increase in body temperature on the day of vaccination that may last up to 24 hours, and swelling or redness at the injection site that resolves without treatment within seven days. A slightly depressed behaviour which may affect up to 1 in 10 animals can be observed on the day of vaccination.
None.
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 vaccinated with Enteroporc Coli AC is ‘zero’ days, which means that there is no mandatory waiting time.
The European Medicines Agency decided that Enteroporc Coli AC’s benefits are greater than its risks and it can be authorised for use in the EU.
Enteroporc Coli AC received a marketing authorisation valid throughout the EU on 9 December 2020.
Product information
Latest procedure affecting product information:
IAIN/0004-G
28/04/2021
Product details
- Name of medicine
- Enteroporc Coli AC
- Active substance
- CLOSTRIDIUM PERFRINGENS TYPE C, BETA1 TOXOID / Clostridium perfringens, type A, alpha toxoid / Clostridium perfringens, type A, beta2 toxoid / Escherichia coli, fimbrial adhesin F4ab / Escherichia coli, fimbrial adhesin F4ac / Escherichia coli, fimbrial adhesin F5 / Escherichia coli, fimbrial adhesin F6
- International non-proprietary name (INN) or common name
- neonatal piglet colibacillosis (recombinant, inactivated)
- Clostridium perfringens vaccine (inactivated)
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AB08
Pharmacotherapeutic group
- Immunologicals for suidae
- Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium
Therapeutic indication
For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:
- Clinical signs (severe diarrhoea) and mortality caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6
- Clinical signs (diarrhoea during the first days of life) associated with Clostridium perfringens type A expressing alpha and beta 2 toxins
- Clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by Clostridium perfringens type C expressing beta1 toxin
News on Enteroporc Coli AC
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