Locatim
European Medicines Agency Veterinary Medicines
EMEA/V/C/041
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
LOCATIM
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 Locatim?
Locatim is an oral solution produced from colostrum which is given to calves in the first 12 hours of life. It contains specific immunoglobulins G (a type of antibody) against Escherichia coli F5 adhesin as its active substance. These immunoglobulins protect calves against disease caused by bacteria. Locatim is presented in a 60 ml glass bottle.
What is Locatim used for?
Locatim is used to reduce death in newborn calves caused by enterotoxicosis due to the bacterium E. coli during the first days of life. Enterotoxicosis is a disease caused by the release of toxins in the body, with the main symptom being diarrhoea. Locatim is given to calves less than 12 hours old, preferably within the first four hours after birth, as a supplement to natural colostrum (first milk) that the calves receive from their mother. The dose of 60 ml (one vial) may be given alone or dissolved in milk or milk substitute.
How does Locatim work?
Locatim works by supplementing the protective properties of normal colostrum, the first milk made by cows after giving birth, which their calves drink during the first few hours of life. Colostrum contains antibodies that help to protect the calves against certain infections. Locatim is made from colostrum from cows that have been immunised against E. coli, so that they produce antibodies in their colostrum. The colostrum is collected and filtered and the lactoserum (the whey, the liquid part of milk) is concentrated to make Locatim. By providing additional antibodies against E. coli, calves receiving Locatim gain additional protection against this bacterium. The natural uptake of colostrum within the first hours of life induces passive immunisation. Locatim thereby provides additional protection against deaths due to enterotoxicosis caused by E. coli.
How has Locatim been studied?
The results of field-based studies looking at diarrhoea in newborn calves are difficult to interpret, since diarrhoea has many causes and the severity of the disease depends on a variety of factors including, but not limited to, the nature and virulence of the organism(s) to which the calves are exposed and the general standards of hygiene and husbandry on the farm.
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What benefit has Locatim shown during the studies?
In the laboratory-based study, calves receiving Locatim had less severe clinical signs of diarrhoea and better survival time than those that did not receive it. These results were confirmed in a field-based study.
What is the risk associated with Locatim?
There are no major side effects with Locatim.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
There are no special precautions for Locatim.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
The withdrawal period is zero days.
Why has Locatim been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Locatim exceed the risks for the treatment of calves less than 12 hours of age to reduce mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam, and recommended that Locatim be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
Other information about Locatim:
The European Commission granted a marketing authorisation valid throughout the European Union for Serinucoli to Biokema Anstalt on 29 March 1999. The name of the medicine was changed to Locatim on 14 September 1999. The marketing authorisation was renewed on 29 March 2004. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in September 2007.
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