Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin
Biokema Anstalt
QI02AT01
Locatim, oral solution for neonatal calves less than 12 hours of age
Calves, neonatal less than 12 hrs of age
Immunologicals for bovidae
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.
Revision: 15
Authorised
1999-03-29
15 B. PACKAGE LEAFLET _ _ 16 PACKAGE LEAFLET: LOCATIM ORAL SOLUTION FOR NEONATAL CALVES LESS THAN 12 HOURS OF AGE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT _ _ Marketing authorisation holder and manufacturer responsible for batch release: Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, FÜRSTENTUM LIECHTENSTEIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Locatim oral solution for neonatal calves less than 12 hours of age 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) _ _ Bovine concentrated lactoserum containing specific immunoglobulins G against _E. coli_ F5 (K99) adhesin 2.8* log 10 /ml. * ELISA method _ _ Methyl parahydroxybenzoate 0.8 mg/ml. 4. INDICATION(S) 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. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Neonatal calves less than 12 hours of age. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth. 17 9. 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, preferably, as soon as it is receptive. 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. 10. WITHDRAWAL PERIOD(S) _ _ Zero days. Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Locatim, oral solution for neonatal calves less than 12 hours of age 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Bovine concentrated lactoserum containing specific immunoglobulins G against _E. coli_ F5 (K99) adhesin 2.8* log 10 /ml. * ELISA method EXCIPIENT Methyl parahydroxybenzoate 0.8 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Neonatal calves less than 12 hours of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals This product may contain antibodies against BVD virus. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4.7 USE DURING PREGNANCY OR LACTATION The product is not intended for use during pregnancy and lactation. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product. A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product Pročitajte cijeli dokument