Locatim (previously Serinucoli)

Authorised

This medicine is authorised for use in the European Union

locatim, oral solution for neonatal calves less than 12 hours of age

Overview

Locatim is a veterinary medicine used to reduce death in newborn calves caused by enterotoxicosis due to the bacterium Escherichia 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 contains the active substance bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin.

How is Locatim used?

The medicine can only be obtained with a prescription.

Locatim is an oral solution produced from colostrum (first milk) which is given to calves less than 12 hours old, preferably within the first four hours after birth, as a supplement to natural colostrum 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.

For more information about using Locatim, see the package leaflet or contact your veterinarian or pharmacist.

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.

What benefits of Locatim have been shown in studies?

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.

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 are the risks associated with Locatim?

There are no major side effects with Locatim.

For the full list of side effects and restrictions of Locatim, see the package leaflet.

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 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 calves treated with Locatim is zero days.

Why is Locatim authorised in the EU?

The European Medicines Agency decided that Locatim’s benefits are greater than its risks and it can be authorised for use in the EU.

Other information about Locatim

Serinucoli received a marketing authorisation valid throughout the EU on 29 March 1999.

The name of the medicine was changed to Locatim on 14 September 1999.

Locatim : EPAR - Medicine overview

Reference Number: EMA/384403/2007

Product information

Locatim : EPAR - Product Information

Locatim : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Locatim (previously Serinucoli)
• Active substance:
  Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin
• International non-proprietary name (INN) or common name:
  locatim, oral solution for neonatal calves less than 12 hours of age
• Species:
  Calves, neonatal less than 12 hrs of age
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AT01

Pharmacotherapeutic group

Immunologicals for Bovidae

Therapeutic indication

Reduction of 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.

Authorisation details

• EMA product number:
  EMEA/V/C/000041
• Marketing authorisation holder:
  Biokema Anstalt

  Pflugstrasse 12; Fürstentum; 9490 Vaduz; Liechtenstein

• Opinion adopted:
  09/12/1998
• Marketing authorisation issued:
  29/03/1999
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Locatim : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Locatim : EPAR - Scientific Discussion

Locatim : EPAR - Procedural steps taken before authorisation