Nobilis Salenvac ETC Suspension for Injection for Chickens

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Salmonella enteritidis, Salmonella Infantis, Salmonella typhimurium

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QI01AB01

INN (שם בינלאומי):

Salmonella enteritidis, Salmonella Infantis, Salmonella typhimurium

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Chickens

איזור תרפויטי:

Inactivated Bacterial Vaccine

מצב אישור:

Authorized

תאריך אישור:

2020-05-18

מאפייני מוצר

Revised: May 2023
AN: 00960/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Salenvac ETC suspension for injection for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 ml contains:
ACTIVE SUBSTANCES:
Inactivated _Salmonella_ Enteritidis, strain PT4:
1 – 6.6 RP*
Inactivated_ Salmonella _Typhimurium, strain DT104:
1 – 16.1 RP
Inactivated _Salmonella _Infantis, strain A, S03499-06:
1 – 26.6 RP
*RP (relative potency): Ratio of antigenic mass (in Units) as compared
to the
antigenic mass (in Units) of a reference batch which was shown to be
efficacious in
chickens.
ADJUVANT:
Aluminium hydroxide:
125 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Thiomersal
0.065 mg
Tris (trometamol)
Maleic acid
Sodium chloride
Water for injections
A homogeneous, cream to mid-brown suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens (breeders and layers).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the active immunisation of chickens from 6 weeks of age to reduce
colonisation
and faecal excretion of _S. _Enteritidis (serogroup D), _S.
_Typhimurium and _S_.
Heidelberg (serogroup B), _S._ Infantis, _S_. Hadar and _S_. Virchow
(serogroup C).
Onset of immunity after the second vaccination
_S._ Enteritidis, _S._ Typhimurium, _S._ Infantis,_ S. _Hadar and _S.
_Virchow:
4 weeks
Revised: May 2023
AN: 00960/2022
Page 2 of 5
_S._ Heidelberg:
9 weeks*
*Earliest timepoint investigated
Duration of immunity after the second vaccination
_S._ Enteritidis:
48 weeks (evidenced by challenge) and 90 weeks (evidenced
by serology)
_S._ Typhimurium:
57 weeks (evidenced by challenge) and 90 weeks (evidenced
by serology)
_S._ Infantis:
51 weeks (evidenced by challenge)
_S._ Hadar:
51 weeks (evidenced by challenge)
_S._ Virchow:
51 weeks (drawn from scientific reasoning)
_S._ Heidelberg:
57 weeks (drawn from scienti