Nobilis Salenvac ETC Suspension for Injection for Chickens

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

Salmonella enteritidis, Salmonella Infantis, Salmonella typhimurium

から入手可能:

MSD Animal Health UK Limited

ATCコード:

QI01AB01

INN（国際名）:

Salmonella enteritidis, Salmonella Infantis, Salmonella typhimurium

医薬品形態:

Suspension for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Chickens

治療領域:

Inactivated Bacterial Vaccine

認証ステータス:

Authorized

承認日:

2020-05-18

製品の特徴

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