Coliprotec F4
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
29-01-2020
Produktets egenskaber
(SPC)
29-01-2020
Offentlige vurderingsrapport
(PAR)
20-03-2015
Aktiv bestanddel:
live non-pathogenic Escherichia coli O8:K87
Tilgængelig fra:
Prevtec Microbia GmbH
ATC-kode:
QI09AE03
INN (International Name):
Escherichia coli, type 08, strain K87 (live)
Terapeutisk gruppe:
Pigs
Terapeutisk område:
Immunologicals for suidae, Live bacterial vaccines, Pig
Terapeutiske indikationer:
For active immunisation of pigs against enterotoxigenic F4-positive Escherichia coli in order to:reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs;reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.
Produkt oversigt:
Revision: 2
Autorisation status:
Withdrawn
Autorisation dato:
2015-03-16
Indlægsseddel
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
Coliprotec F4
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:
Prevtec Microbia GmbH
Geyerspergerstr. 27
80689 München
GERMANY
Manufacturer responsible for batch release:
CZ Veterinaria S.A.
Poligono La Relva, Torneiros s/n
36410 Porriño (Pontevedra)
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4 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 _Escherichia coli_ O8:K87 (F4ac)
1
............................1.3x 10
8
to 9.0 x10
8
CFU
2
/dose
1
not attenuated
2
CFU = colony forming units
White or whitish lyophilisate.
4.
INDICATION(S)
For active immunisation of pigs against enterotoxigenic F4-positive
_Escherichia coli_ in order to:
-
reduce the incidence of moderate to severe post-weaning _Escherichia
coli _diarrhoea (PWD) in
pigs
-
reduce the colonisation of the ileum and faecal shedding of
enterotoxigenic F4-positive
_Escherichia coli_ from infected pigs.
Onset of immunity: 7 days after vaccination.
Duration of immunity: 21 days after vaccination.
5.
CONTRAINDICATIONS
None.
16
6.
ADVERSE REACTIONS
A transient reduced weight gain was observed during the first week
after vaccination in studies.
Shivering was very commonly observed after vaccination in studies.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed i
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4 lyophilisate for oral suspension for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
Live non-pathogenic _Escherichia coli_ O8:K87
1
.(F4ac).............1.3 x10
8
to 9.0 x10
8
CFU
2
/dose
1
not attenuated
2
CFU – colony forming units
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White or whitish lyophilisate for oral suspension.
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 _Escherichia _
_coli_ in order to:
-
reduce the incidence of moderate to severe post-weaning _Escherichia
coli _diarrhoea (PWD) in
pigs.
-
reduce the colonisation of the ileum and faecal shedding of
enterotoxigenic F4-positive
_Escherichia 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
Do not vaccinate animals undergoing immunosuppressive treatment.
Do not vaccinate animals undergoing antibacterial treatment effective
against _Escherichia coli_.
Vaccinate healthy animals only.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Apply the usual aseptic precautions to all administration procedures.
The vaccine strain may be excreted by vaccinated piglets for at least
14 days following vaccination.
The vaccine strain readily spreads to other pigs in contact to
vaccinated pigs. Unvaccinated pigs in
contact with vaccinated pigs will harbour and shed the vaccine strain
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
Personal protective equipment consisting of protective disposable
gloves and safety glas
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