Locatim (previously Serinucoli)
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-10-2021
Charakterystyka produktu
(SPC)
20-10-2021
Sprawozdanie z oceny publicznego
(PAR)
23-02-2021
Składnik aktywny:
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin
Dostępny od:
Biokema Anstalt
Kod ATC:
QI02AT01
INN (International Nazwa):
Locatim, oral solution for neonatal calves less than 12 hours of age
Grupa terapeutyczna:
Calves, neonatal less than 12 hrs of age
Dziedzina terapeutyczna:
Immunologicals for bovidae
Wskazania:
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.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
1999-03-29
Ulotka dla pacjenta
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.
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Charakterystyka produktu
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
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