Enteroporc COLI Suspension for Injection for Pigs

Држава: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Escherichia coli

Доступно од:

Ceva Animal Health Ltd

АТЦ код:

QI09AB02

INN (Међународно име):

Escherichia coli

Фармацеутски облик:

Suspension for injection

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Pigs

Терапеутска област:

Inactivated Bacterial Vaccine

Статус ауторизације:

Expired

Датум одобрења:

2021-01-27

Карактеристике производа

Revised: October 2022
AN: 01757/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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).
Revised: October 2022
AN: 01757/2022
Page 2 of 5
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.
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 adv