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Oral solution containing a high concentration of specific immunoglobulins for calves.

European approval. Marketing authorisation number: EU/2/99/011/001

The aim of this specifically concentrated immunoglobulin solution is to provide newborn calves with additional immunoglobulins in order to supplement the protective characteristics of normal colostrum against neonatal calf diarrhoea.

Legal Category: POM (Prescription Only Medecine)

STATEMENT OF THE ACTIVE SUBSTANCES

Bovine concentrated lactoserum containing specific Immunoglobulins G against E. coli F5 (K99) adhesin > 2.8*log10/ml.
* microagglutination method
Parabens < 1.0 mg/ml

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSEBLE FOR
BATCH RELEASE, IF DIFFERENT

Biokema Anstalt,
Aeulestrasse 38,
9490 Vaduz,
Fürstentum Liechtenstein

Merial Laboratoire de Gerland
Av. Marcel Mérieux 254
69342 Lyon Cedex 07
France

TARGET SPECIES

Neonatal calves less than 12 hours of age

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.

DOSAGE FOR EACH SPECIES

60 ml (1 bottle) for each neonatal calf less than 12 hours of age.

METHOD AND ROUTE OF ADMMISTRATION

Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.

ADVICE ON CORRECT ADMINISTRATION

The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf's life. If the calf is reluctant to take the product, it may be administered via an ordinary syringe placed in the mouth. The calf must be given other normal colostrum in addition to the product. In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.

CONTRA-INDICATIONS

None known

UNDESIRABLE EFFECTS

None known

WITHDRAWAL PERIOD

Zero days

SPECIAL STORAGE CONDITIONS

- Store at 2°C - 8°C.
- Keep the container in the outer carton.
- Do not freeze.

SPECIAL WARNINGS

This product may contain antibodies against BVD virus. The product is not intended for use during pregnancy and lactation. The product is produced from colostrum collected from cows kept under field conditions. Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/or exposure of the donor cows to organisms in their environment. This should be borne in mind when planning vaccination programmes for calves, which receive Locatim. Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose. In the absence of incompatibility studies this veterinary medicinal product must not be mixed with other medicinal products.

The import, sale, supply and/or use of Locatim is/or may be prohibited in certain Member States on the whole or part of their territory pursuant to National animal health policy. Any person intending to import, sell, supply and/or use Locatim has to consult the relevant Member States competent Authorities on the current animal health policies prior to the import, sale, supply and/or use.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local requirements.

OTHER INFORMATION

The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
For any information about this veterinary medicinal product, please contact the
local representative of the Marketing Authorisation Holder.

Product description

- Legal Category: POM (Prescription Only Medecine)

- Veterinary product. Animal use only.

- Read the leaflet before administration.

- For more information: ask your veterinarian or your pharmacist.

- Marketing authorisation number: EU/2/99/011/001

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