Coliprotec F4/F18
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
22-11-2021
Produktets egenskaber
(SPC)
22-11-2021
Offentlige vurderingsrapport
(PAR)
06-02-2017
Aktiv bestanddel:
Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)
Tilgængelig fra:
Elanco GmbH
ATC-kode:
QI09AE03
INN (International Name):
porcine post-weaning diarrhoea vaccine (live)
Terapeutisk gruppe:
Pigs
Terapeutisk område:
Immunologicals for suidae, Live bacterial vaccines
Terapeutiske indikationer:
For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18-positive Escherichia coli in order to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) in infected pigs and to reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.
Produkt oversigt:
Revision: 5
Autorisation status:
Authorised
Autorisation dato:
2017-01-09
Indlægsseddel
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
COLIPROTEC F4/F18 LYOPHILISATE FOR ORAL SUSPENSION FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
GERMANY
Manufacturer responsible for batch release:
Klifovet AG
Geyerspergerstr. 27
80689 München
GERMANY
Lohmann Animal Health GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4/F18 lyophilisate for oral suspension for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of vaccine contains:
Live non-pathogenic
_E. coli_
O8:K87
*
(F4ac):.......................1.3x10
8
to 9.0x10
8
CFU
**
Live non-pathogenic
_E. coli_
O141:K94
*
(F18ac):.................2.8x10
8
to 3.0x10
9
CFU
**
*
not attenuated
**
CFU – colony forming units
White or whitish powder.
4.
INDICATION(S)
For active immunisation of pigs from 18 days of age against
enterotoxigenic F4-positive and F18-
positive
_E. coli_
in order to:
-
reduce the incidence of moderate to severe post-weaning
_E. coli_
diarrhoea (PWD) in infected pigs;
-
reduce the faecal shedding of enterotoxigenic F4-positive and
F18-positive
_E. coli_
from infected
pigs.
Onset of immunity: 7 days after vaccination
Duration of immunity: 21 days after vaccination
5.
CONTRAINDICATIONS
16
None
6.
ADVERSE REACTIONS
No adverse reactions have been observed.
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
Pigs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
Administer a single dose of vaccine from 18 days of age.
9.
ADVICE ON CORRECT ADMINISTRATION
All materials used in preparing and administering the vaccine must be
free of antimicrobials, detergent
or disinfectant residues to prevent inactivation.
Vaccination schedule
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4/F18 lyophilisate for oral suspension for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
ACTIVE SUBSTANCES:
Live non-pathogenic
_Escherichia coli_
O8:K87
*
(F4ac):.......................1.3x10
8
to 9.0x10
8
CFU
**
Live non-pathogenic
_Escherichia coli_
O141:K94
*
(F18ac): ...............2.8x10
8
to 3.0x10
9
CFU
**
*
not attenuated
**
CFU – colony forming units
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
White or whitish powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 18 days of age against
enterotoxigenic F4-positive and F18-
positive
_Escherichia coli_
in order to:
-
reduce the incidence of moderate to severe post-weaning
_E. coli_
diarrhoea (PWD) in infected pigs;
-
reduce the faecal shedding of enterotoxigenic F4-positive and
F18-positive
_E. coli_
from infected
pigs.
Onset of immunity: 7 days after vaccination
Duration of immunity: 21 days after vaccination
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is not recommended to vaccinate animals undergoing
immunosuppressive treatment or to vaccinate
animals undergoing antibacterial treatment effective against
_E. coli. _
_ _
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for use in animals
The vaccine strains may be excreted by vaccinated piglets for at least
14 days following vaccination.
The vaccine strains readily spread to other pigs in contact to
vaccinated pigs. Unvaccinated pigs in
contact with vaccinated pigs will harbour and shed the vaccine strains
similarly to vaccinated pigs.
During this time, the contact of immunosuppressed pigs with vaccinated
pigs should be avoided.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Per
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