Nobilis Salenvac

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Salmonella enteritidis

Fáanlegur frá:

MSD Animal Health UK Limited

ATC númer:

QI01AB01

INN (Alþjóðlegt nafn):

Salmonella enteritidis

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Chickens

Lækningarsvæði:

Inactivated Bacterial Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

1995-04-28

Vara einkenni

Revised: August 2020
AN: 00299/2020
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Salenvac
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Formalin killed cells of _Salmonella _Enteritidis phage type 4
2 x 10
9
ADJUVANT:
Alhydrogel, (containing 3% aluminium hydroxide)
250 mg
EXCIPIENT:
Thiomersal (preservative)
0.13 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens: - layers and breeders
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of poultry against _ Salmonella _
Enteritidis_, _ to reduce
shedding of _S. _Enteritidis into the environment.
Antibodies
against
_S. _
Enteritidis
develop
within
a
few
weeks
of
the
second
vaccination.
A second peak is achieved shortly after a third vaccination. These
antibodies have
been shown to persist for at least 60 weeks. Passive immunity will be
transferred via
the egg to the progeny for at least 57 weeks.
4.3
CONTRAINDICATIONS
Do not use in laying birds.
Revised: August 2020
AN: 00299/2020
Page 2 of 4
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Cross reactions in tests for _S. _Pullorum_ _are possible but at a low
level and may be
distinguished from true infection when dilutions of sera are tested,
or following heat
inactivation. Where serology is positive for _ S. _ Pullorum, the
diagnosis should be
confirmed
by
bacteriology.
Hygienic
measures
and
monitoring
should
not
be
neglected.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In the case of accidental self injection, seek medical advice
immediately and show
the package insert or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The vaccine contains an adjuvant and may cause a temporary nodule at
the site of
injection, up to 5 mm in diameter, lasting for up to 2 to 3 days.
4.7