Poulvac E. coli Lyophilisate for Suspension for Spray Vaccination for Chickens and Turkeys or for Use in Drinking Water for Chickens

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Escherichia coli

Inapatikana kutoka:

Zoetis UK Limited

ATC kanuni:

QI01AE04

INN (Jina la Kimataifa):

Escherichia coli

Dawa fomu:

Lyophilisate for suspension for spray administration

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Chickens, Turkeys

Eneo la matibabu:

Live Bacterial Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

2012-06-15

Tabia za bidhaa

Amended Pages: May 2022
AN: 02083/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Amended Pages: May 2022
AN: 02083/2020
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not vaccinate animals undergoing antibacterial or immunosuppressive
treatment.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Do not use antibioti