Nobilis Salenvac T Suspension for Injection for Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Salmonella enteritidis, Salmonella typhimurium

Available from:

MSD Animal Health UK Limited

ATC code:

QI01AB01

INN (International Name):

Salmonella enteritidis, Salmonella typhimurium

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2000-08-17

Summary of Product characteristics

Revised: August 2020
AN: 00299/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Salenvac T Suspension for injection for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
ACTIVE SUBSTANCES:
Inactivated cells of _Salmonella _Enteritidis, strain PT 4:
≥ 1 RP*
Inactivated cells of _Salmonella _Typhimurium, strain DT104:
≥ 1 RP*
EXCIPIENTS:
Adjuvant: aluminium hydroxide:
125 mg
Preservative: thiomersal:
0.065 mg
For a list of excipients, see section 6.1.
* RP = relative potency = mean antibody response in rabbit potency
test equal
to or greater than a reference batch which was shown to be efficacious
in
chickens
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (breeders and layers)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens and the passive immunisation
of the
progeny to reduce caecum colonisation and faecal excretion with _S.
_Enteritidis
and _S. _Typhimurium_._
Active immunity:
Onset of immunity: 4 weeks after the second administration
Duration of immunity: until approximately 56-60 weeks of age for
chickens
vaccinated at 12 and 16 weeks.
Minor indication: In exceptional circumstances chickens from one day
of age
may be vaccinated in order to protect them in an environment where
they are
likely
to
become
infected
at
an
early
stage
in
the
rearing
phase
Revised: August 2020
AN: 00299/2020
Page 2 of 6
(epidemiologically indicated by recent outbreak of Salmonella or high
infection
pressure on the site).
Onset of immunity: 4 weeks after the second administration.
Passive immunity:
Onset of immunity: day one after hatching.
Duration of immunity: until 14 days after hatching.
Passive immunity is transferred from 4 weeks after the second
vaccination up
to 59 weeks of age of the parent bird.
4.3
CONTRAINDICATIONS
Do not use in laying birds.
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
No st