Enteroporc Coli

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6

Available from:

CEVA Santé Animale

ATC code:

QI09AB02

INN (International Name):

Neonatal piglet colibacillosis vaccine (recombinant, inactivated)

Therapeutic group:

Pigs

Therapeutic area:

Immunologicals for suidae

Therapeutic indications:

For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce clinical signs (severe diarrhoea) and mortality caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6.

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2021-01-06

Patient Information leaflet

13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
ENTEROPORC COLI SUSPENSION FOR INJECTION 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:
Ceva Santé Animale
10 av. de La Ballastière
33500 Libourne
France
Manufacturer responsible for batch release:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enteroporc COLI suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENT
One dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated fimbrial adhesins of
_Escherichia coli_
:
F4ab
≥
23 rU/ml*
F4ac
≥
19 rU/ml*
F5
≥
13 rU/ml*
F6
≥
37 rU/ml*
* fimbrial adhesins content in relative units per ml, determined in
ELISA against an internal standard
ADJUVANT:
Aluminium (as hydroxide)
2.0 mg/ml
Yellowish suspension.
4.
INDICATIONS
For the passive immunisation of progeny by active immunisation of
pregnant sows and gilts to reduce
clinical signs (severe diarrhoea) and mortality caused by
_E. coli_
strains expressing the adhesins F4ab,
F4ac, F5 and F6.
Onset of immunity (after uptake of colostrum):
within 12 hours after birth
Duration of immunity (after uptake of colostrum): first days of life.
5.
CONTRAINDICATIONS
15
None.
6.
ADVERSE REACTIONS
A transient increase in body temperature (mean 0.5 °C, in individual
pigs up to 2 °C) occurred very
commonly on the days of vaccination which returned to normal within 24
hours.
A transient swelling and redness at the injection site (mean 2.8 cm,
in individual pigs up to 8 cm) was
very commonly observed which disappeared without treatment within 7
days.
A slightly depressed behaviour was commonly observed on the days of
vaccination.
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)
- unc

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enteroporc COLI suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated fimbrial adhesins of
_Escherichia coli_
:
F4ab
≥ 23 rU/ml*
F4ac
≥ 19 rU/ml*
F5
≥ 13 rU/ml*
F6
≥ 37 rU/ml*
* fimbrial adhesins content in relative units per ml, determined by
ELISA against an internal standard
ADJUVANT:
Aluminium (as hydroxide)
2.0 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Yellowish suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (pregnant sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive immunisation of progeny by active immunisation of
pregnant sows and gilts to reduce
clinical signs (severe diarrhoea) and mortality caused by
_Escherichia coli_
strains expressing the
fimbrial adhesins F4ab, F4ac, F5 and F6.
Onset of immunity (after uptake of colostrum): within 12 hours after
birth
Duration of immunity (after uptake of colostrum): first days of life.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient increase in body temperature (mean 0.5 °C, in individual
pigs up to 2 °C) occurred very
commonly on the days of vaccination which returned to normal within 24
hours.
A transient swelling and redness at the injection site (mean 2.8 cm,
in individual pigs up to 8 cm) was
very commonly observed which disappeared without treatment within 7
days.
A slightly depressed behaviour was commonly observed on the days of
vaccination.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than