Bovilis Bovivac S suspension for injection for cattle

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Salmonella dublin strain s342/70 formalin inactivated; Salmonella typhimurium strain s341/70 formalin inactivated

Beschikbaar vanaf:

Intervet Ireland Limited

ATC-code:

QI02AB

INN (Algemene Internationale Benaming):

Salmonella dublin strain s342/70 formalin inactivated; Salmonella typhimurium strain s341/70 formalin inactivated

Dosering:

.

farmaceutische vorm:

Suspension for injection

Prescription-type:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Therapeutische categorie:

Cattle

Therapeutisch gebied:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

therapeutische indicaties:

Immunological - Inactivated Vaccine

Autorisatie-status:

Authorised

Autorisatie datum:

2001-09-05

Productkenmerken

1
Final / 128309 /10 .0
Final / 128309 /10 .0
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Bovivac S suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains:
ACTIVE SUBSTANCES:
Inactivated cells of
_Salmonella dublin _
strain S342/70
1 x 10
9
cells
Inactivated cells of
_Salmonella typhimurium _
strain S341/70
1 x 10
9
cells
ADJUVANT:
Aluminium hydroxide gel
200 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Tris buffer
Maleic acid
Sodium chloride
Formaldehyde
Thiomersal
0.13 mg
Water for injections
Opaque fluid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the active immunisation of cattle in order to induce serological
and colostral antibody production
against
_Salmonella dublin _
and
_Salmonella typhimurium _
and in the face of an outbreak to reduce
_Salmonella typhimurium _
infections when used under field conditions as part of an overall herd
management programme. This product may also contribute to reducing
_S. typhimurium _
contamination
of the environment.
Specific experimental data to quantify the duration of immunity, the
effectiveness of a single dose re-
vaccination or the degree of protection from colostral antibodies has
not been generated.
Significant levels of immunity cannot be expected until two weeks
after the second dose of the
primary vaccination course.
3.3
CONTRAINDICATIONS
2
Final / 128309 /10 .0
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
All stock showing overt clinical signs of salmonellosis at the time of
the initial vaccination programme
should receive appropriate treatment and be fully vaccinated once they
have recovered. Any
unvaccinated stock must be managed separately to vaccinated stock,
with no contact between the
groups. Hygi