Patient leaflet - Locatim (previously Serinucoli)
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Locatim oral solution for neonatal calves less than 12 hours of age
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Locatim oral solution for neonatal calves less than 12 hours of age
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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* logw/ml.
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* ELISA method
Methyl parahydroxybenzoate < 0.8 mg/ml.
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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.
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5. CONTRAINDICATIONS
None.
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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.
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7. TARGET SPECIES
Neonatal calves less than 12 hours of age.
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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.
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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.
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10. WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
Keep the bottle in the outer carton.
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
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12. SPECIAL WARNINGS
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.
Special precautions for use in animals:
This product may contain antibodies against BVD virus.
Pregnancy and lactation:
The product is not intended for use during pregnancy and lactation.
Interactions with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this product when used with any other veterinary medicinal product. A decision to use this product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Overdose (symptoms, emergency procedures, antidotes):
Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Incompatibilities:
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ().
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15. OTHER INFORMATION