ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Locatim, oral solution for neonatal calves less than 12 hours of age
2.
Active substance
Bovine concentrated lactoserum containing specific Immunoglobulins G against
E. coli
F5 (K99)
adhesin
≥
Excipient(s)
Methyl parahydroxybenzoate
≤
0.8 mg/ml
Propyl parahydroxybenzoate
≤
0.2 mg/ml
For a full list of excipients, see section 6.1.
3.
Oral solution
4.
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.
None.
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.
This product may contain antibodies against BVD virus.
2/17
2.8* log
10
/ml.
* microagglutination method
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None.
None known.
4.7 Use during pregnancy or lactation
The product is not intended for use during pregnancy and lactation.
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 on the same day or at different times with
any other veterinary medicinal product therefore needs to be made on a case by case basis.
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.
Transient effects of temperature increase and respiration rate increase have been seen when the
product is administered in a double dose.
Zero days
5.
The product supplements the protective properties of normal colostrum against
E. coli
F5 (K99)
adhesin.
ATC vet code: QI02AT01
6.
6.1 List of excipients
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
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6.2 Incompatibilities
In the absence of incompatibility studies this veterinary medicinal product must not be mixed with
other veterinary medicinal products.
6.3 Shelflife
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.
6.5 Nature and composition of immediate packaging
Cardboard box with one 60 ml type III glass bottle closed with a polypropylene stopper with a
polyethylene seal and a detachable lock-ring.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Biokema Anstalt,
Pflugstrasse 12,
9490 Vaduz,
Fürstentum Liechtenstein
8.
EU/2/99/011/001
9.
29.03.1999 / 05.12.2008
01.2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu.
PROHIBITION OF SALE, SUPPLY AND/OR USE
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
4/17
import, sell, supply and/or use Locatim must consult the relevant Member State’s competent authority
on the current animal health policies prior to the import, sale, supply and/or use.
5/17
ANNEX II
A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
6/17
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
Biokema SA
Chemin de la Chatanérie 2
1023 Crissier-Lausanne
Switzerland
Name and address of the manufacturer(s) responsible for batch release
Merial Laboratoire Porte des Alpes
Rue de l’aviation
69800 Saint Priest
France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary
medicinal product on the whole or part of their territory if it is established that:
a) the administration of the veterinary medicinal product to animals will interfere with the
implementation of national programmes for the diagnosis, control and eradication of animal
diseases, or will cause difficulties in certifying the absence of contamination in live animals or
in foodstuffs or other products obtained from treated animals.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
absent from the territory.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Active substance specific immunoglobulins : not applicable
The following excipients are included in Annex II of Council Regulation (EEC) No 2377/90 in
accordance with the following table:
7/17
Pharmacologically active substance Animal Species
Other provisions
Calcium chloride
1
All food-producing species
Sodium chloride
2
All food- producing species
Lactic acid
3
All food-producing species
Sodium hydroxide
4
All food- producing species
Sodium methyl hydroxybenzoate
5
All food-producing species
Sodium propyl hydroxybenzoate
6
All food- producing species
Sodium propionate
7
All food-producing species
Propionic acid
8
All food- producing species
1
OJ No. L 110 of 17.05.95
2
OJ No. L 272 of 25.10.96
3
OJ No. L 108 of 29.04.94
4
OJ No. L 272 of 25.10.96
5
OJ No. L 272 of 25.10.96
6
OJ No. L 272 of 25.10.96
7
OJ No. L 272 of 25.10.96
8
OJ No. L 272 of 25.10.96
8/17
ANNEX III
LABELLING AND PACKAGE LEAFLET
9/17
A. LABELLING
10/17
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
BOX
1.
Locatim oral solution for neonatal calves less than 12 hours of age
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Bovine concentrated lactoserum containing specific Immunoglobulins G against
E. coli
F5 (K99)
adhesin
≥
2.8 log
10
/ml.
Methyl parahydroxybenzoate
≤
0.8 mg/ml
Propyl parahydroxybenzoate
≤
0.2 mg/ml
3.
Oral solution
4.
PACKAGE SIZE
60 ml.
5.
Neonatal calves less than 12 hours of age
6.
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.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
8.
Withdrawal period: Zero days
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
11/17
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator.
Keep the bottle in the outer carton.
Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
certain Member States on the whole or part of their territory, see package leaflet for further
information.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Biokema Anstalt,
Pflugstrasse 12,
9490 Vaduz,
Fürstentum Liechtenstein
EU/2/99/011/001
17. MANUFACTURER’S BATCH NUMBER
Batch{number}
12/17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL
1.
Locatim oral solution for neonatal calves less than 12 hours of age
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Bovine concentrated lactoserum containing specific Immunoglobulin G against E. coli F5(K99)
adhesion
>
2.8 log 10/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
60 ml
4.
ROUTE(S) OF ADMINISTRATION
Oral administration of 60ml as soon as possible, preferably given within the first 4 hours, but not later
than 12 hours after birth.
5.
Withdrawal period: zero days
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
13/17
B. PACKAGE LEAFLET
14/17
PACKAGE LEAFLET FOR:
Locatim oral solution for neonatal calves less than 12 hours of age
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
Biokema Anstalt,
Pflugstrasse 12,
9490 Vaduz,
Fürstentum Liechtenstein
Manufacturer for the batch release:
Merial Laboratoire Porte des Alpes
Rue de l’aviation
69800 Saint Priest
France
2.
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
≥
Methyl parahydroxybenzoate
≤
0.8 mg/ml
Propyl parahydroxybenzoate
≤
0.2 mg/ml
4.
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.
None
6.
ADVERSE REACTIONS
None known.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Neonatal calves less than 12 hours of age.
15/17
2.8* log
10
/ml.
* microagglutination method
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.
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
Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2 °C - 8 °C)
Keep the bottle in the outer carton.
Do not freeze.
Do not use after the expiry date stated on the label.
12. 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.
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 on the same day or at different times with
any other veterinary medicinal product therefore needs to be made on a case by case basis.
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 must consult the relevant Member State’s competent authority
on the current animal health policies prior to the import, sale, supply and/or use.
16/17
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
01.2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu.
15. OTHER INFORMATION
The product supplements the protective properties of normal colostrum against
E. coli
F5 (K99)
adhesin.
Pack size: 60 ml bottle.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
17/17
Source: European Medicines Agency
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