Poulvac E. coli

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Live aroA gene deleted Escherichia coli, type 078, strain EC34195

MAH:

Zoetis Belgium SA

ATC_code:

QI01AE04

INN:

Escherichia coli aroA gene deleted, type O78, strain EC34195 (live)

therapeutic_group:

Chicken; Turkeys

therapeutic_area:

Immunologicals for aves, Live bacterial vaccines

therapeutic_indication:

For active immunisation of broiler chickens and future layers / breeders in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.

leaflet_short:

Revision: 10

authorization_status:

Authorised

authorization_date:

2012-06-15

PIL

14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
POULVAC E. COLI LYOPHILISATE FOR SUSPENSION FOR SPRAY VACCINATION FOR
CHICKENS AND TURKEYS OR FOR
USE IN DRINKING WATER FOR CHICKENS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodón, s/n°
Finca La Riba
Vall de Bianya
Gerona, 17813
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac E. coli lyophilisate for suspension for spray vaccination for
chickens and turkeys or for use in
drinking water for chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose contains:
Live aroA gene deleted
_Escherichia coli_
,
type O78, strain EC34195
5.2 x 10
6
- 9.1 x 10
8
CFU*
* Colony forming units when grown on trypticase soy agar plates.
Cream coloured lyophilisate.
Upon reconstitution, transparent to white-yellowish and opaque
suspension (depending on the volume
of diluent used).
4.
INDICATION(S)
For active immunisation of broiler chickens, future layer/breeders and
turkeys in order to reduce
mortality and lesions (pericarditis, perihepatitis, airsacculitis)
associated with
_Escherichia coli_
serotype O78.
Onset of immunity:
Chickens: 2 weeks after vaccination for the reduction of lesions. The
onset of immunity has not been
established for the mortality claim.
Turkeys: 3 weeks after second vaccination for the reduction of lesions
and mortality.
Duration of immunity:
Chickens: 8 weeks for the reduction of lesions and 12 weeks for the
reduction of mortality (spray).
12 weeks for the reduction of lesions and mortality (drinking water).
16
Turkeys: duration of immunity has not been established.
A cross protection study showed reduction of incidence and severity of
airsacculitis caused by
_E. coli_
serotypes O1, O2 and O18 for spray application for chickens. For

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac E. coli lyophilisate for suspension for spray vaccination for
chickens and turkeys or for use in
drinking water for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCE:
Live aroA gene deleted
_Escherichia coli_
,
type O78, strain EC34195
5.2 x 10
6
- 9.1 x 10
8
CFU*
* Colony forming units when grown on trypticase soy agar plates.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for spray vaccination or for use in
drinking water.
Cream coloured lyophilisate.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers, future layers/breeders) and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of broiler chickens, future layer/breeders and
turkeys in order to reduce
mortality and lesions (pericarditis, perihepatitis, airsacculitis)
associated with
_Escherichia coli_
serotype O78.
Onset of immunity:
Chickens: 2 weeks after vaccination for the reduction of lesions. The
onset of immunity has not been
established for the mortality claim.
Turkeys: 3 weeks after second vaccination for the reduction of lesions
and mortality.
Duration of immunity:
Chickens: 8 weeks for the reduction of lesions and 12 weeks for the
reduction of mortality (spray). 12
weeks for the reduction of lesions and mortality (drinking water).
Turkeys: duration of immunity has not been established.
A cross protection study showed reduction of incidence and severity of
airsacculitis caused by
_E. coli_
serotypes O1, O2 and O18 for spray application for chickens. For these
serotypes no onset of
immunity or duration of immunity was established.
4.3
CONTRAINDICATIONS
Do not vaccinate animals undergoing antibacterial or immunosuppressive
treatment.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Do not use antibiotic treatment within 1 week before and after
vaccination because antibiotic treatment
mig