Summary of medicine characteristics - Locatim (previously Serinucoli)
SUMMARY OF PRODUCT CHARACTERISTICS
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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* logw/ml.
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* 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 PARTICULARS4.1 Target species
Neonatal calves less than 12 hours of age.
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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.
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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.
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4.5 Special precautions for use
Special precautions for use in animals
This product may contain antibodies against BVD virus.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
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4.6 Adverse reactions (frequency and seriousness)
None known.
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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 therefore needs to be made on a case by case basis.
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4.9 Amounts to be administered and administration route
Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
ATCvet code: QI02AT01.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Methyl parahydroxybenzoate
6.2 Major incompatibilities
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
6.4 Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Keep the container in the outer carton.
Do not freeze.
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6.5 Nature and composition of immediate packaging
Cardboard box with 1, 6, 12, 24 or 48 60 ml type III glass bottles closed with a polypropylene stopper with a polyethylene seal and a detachable lock-ring.
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6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Biokema Anstalt,
Pflugstrasse 12,
9490 Vaduz,
Fürstentum
LIECHTENSTEIN
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/99/011/001
EU/2/99/011/002
EU/2/99/011/003
EU/2/99/011/004
EU/2/99/011/005
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 29/03/1999.
Date of last renewal: 05/12/2008.