Neocolipor
European Medicines Agency Veterinary Medicines
EMEA/V/C/035
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
NEOCOLIPOR EPAR summary for the public
This document 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 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 Neocolipor?
Neocolipor is an inactivated vaccine intended to be used to reduce neonatal enterotoxicosis (a bacterial infection caused by strains of E.coli) in very young piglets.
What is Neocolipor used for?
Neocolipor is administered to female pigs - both sows and gilts - in order to immunise their offspring against neonatal enterotoxicosis. Gilts are animals which have produced fewer than two litters. The vaccine is given by intramuscular injection.
How does Neocolipor work?
Neocolipor contains inactivated strains of E. coli expressing the adhesins F4ab (K88ab), F4ac (K88ac), F4ad (|K88 ad) F5 (K99) F6 (987P) and F41.
Vaccination of the mother animal (sows and gilts) enables the offspring to receive a passive immunity during their first days of life against neonatal enterotoxicosis caused by E. coli strains carrying the adhesins F4, F5, F6 and F41.
The vaccine is intended for use 5-7 weeks before the birth of the litter (farrowing) with a second vaccination at 2 weeks prior to farrowing. A booster vaccination is given 2 weeks prior to each subsequent farrowing.
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How has Neocolipor been studied?
A number of trials were carried out in both the laboratory and in the field in order to assess the efficacy of the product.
Safety data were also presented for the recommended use of the product both under laboratory conditions and in the field. Safety of the product was satisfactorily demonstrated.
What benefit has Neocolipor shown during the studies?
The results presented showed statistical significance between vaccinates and non-vaccinates and thus demonstrated the efficacy of the vaccine. Re-vaccination was shown to be effective at the intervals recommended.
What are the side-effects of Neocolipor?
Vaccination may cause a slight rise in the animal’s body temperature (less than 1.5°C during a maximum period of 24 hours).
What are the precautions for the person who gives the medicine or comes into contact with the animal?
In the case of accidental self injection, seek medical advice immediately and show the package insert or label to a physician.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Zero days (the vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated animals at the recommended dose).
Why has Neocolipor been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Neocolipor had been shown to be effective in the reduction of neonatal enterotoxicosis in piglets.
Other information about Neocolipor:
The European Commission granted a marketing authorisation, valid throughout the European Union, for Neocolipor to Mérial on 9 August 2002. The Marketing Authorisation was subsequently renewed. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in August 2008.
© EMEA 2008 Page 2/2