Cevac Salmovac Lyophilisate for use in drinking water for chickens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmonella enteritidis, strain no. 441/014

Available from:

Ceva Santé Animale

ATC code:

QI01AE01

INN (International Name):

Salmonella enteritidis, strain no. 441/014

Dosage:

1x10^8 - 8x10^8 Colony forming units

Pharmaceutical form:

Oral lyophilisate

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

salmonella

Authorization status:

Authorised

Authorization date:

2004-03-05

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevac Salmovac
Lyophilisate for use in drinking water for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCE:
_Salmonella _
Enteritidis, strain 441/014
Double-attenuated (adenine-histidine auxotrophic) marker mutant
1 - 8 x 10
8
CFU*
_ _
_* CFU = Colony Forming Unit _
EXCIPIENT:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Sucrose
Light beige to brownish light grey lyophilisate.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens (breeders and layers).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Active immunisation of chickens from one day of age to reduce
colonisation, persistence and invasion
of the intestinal tract and internal organs by
_Salmonella_
Enteritidis and
_Salmonella_
Typhimurium.
Onset of immunity within 6 days after first vaccination.
Duration of immunity for
_Salmonella_
Enteritidis is 35 weeks after second vaccination and 63 weeks
after third vaccination when used according to the recommended
vaccination schedule.
Duration of immunity for
_Salmonella_
Typhimurium is 60 weeks after the third vaccination when used
according to the recommended vaccination schedule.
3.3
CONTRAINDICATIONS
Do not use in broilers.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Vaccinated chickens excrete the vaccine strain up to six weeks
following vaccination. During this
time, the contact of immunosuppressed and unvaccinated chickens with
vaccinated chickens should be
avoided.
The vaccine can spread to susceptible birds. Special precautions
should be taken to avoid spreading of
the vaccine strain to susceptible birds. Contact chickens may also
excrete the vaccine strain.
The vaccine strain has been isolated from chicken litter up to 13 days
after vaccination.
In studies, the vaccine strain can be found in the environment for up
to 8 weeks after the 2
nd
vaccination and 5 weeks after the 3
rd
vaccination.
On very rare occasio