Nobilis Salenvac ETC Suspension for Injection for Chickens

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Salmonella enteritidis, Salmonella Infantis, Salmonella typhimurium

متاح من:

MSD Animal Health UK Limited

ATC رمز:

QI01AB01

INN (الاسم الدولي):

Salmonella enteritidis, Salmonella Infantis, Salmonella typhimurium

الشكل الصيدلاني:

Suspension for injection

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Chickens

المجال العلاجي:

Inactivated Bacterial Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2020-05-18

خصائص المنتج

Revised: May 2023
AN: 00977/2022
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:
Thiomersal:
0.065 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
A homogeneous, cream to mid-brown suspension.
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 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).
Revised: May 2023
AN: 00977/2022
Page 2 of 5
Onset of immunity after the second vaccination
_S._ Enteritidis, _S._ Typhimurium, _S._ Infantis,_ S. _Hadar and _S.
_Virchow:
4 weeks
_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 scientific reasoning)
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIO