AquaVac 6 emulsion for injection for Atlantic salmon

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Inactivated infectious pancreatic necrosis virus; Inactivated aeromonas salmonicida subsp. salmonicida; Vibrio anguillarum, serotype O1, Inactivated; Vibrio anguillarum, serotype O2A, Inactivated; Moritella Viscosa, inactivated; Vibrio Salmonicida, inactivated

זמין מ:

Intervet Ireland Limited

קוד ATC:

QI10AL02

INN (שם בינלאומי):

Inactivated infectious pancreatic necrosis virus; Inactivated aeromonas salmonicida subsp. salmonicida; Vibrio anguillarum, serotype O1, Inactivated; Vibrio anguillarum, serotype O2A, Inactivated; Moritella Viscosa, inactivated; Vibrio Salmonicida, inactivated

טופס פרצבטיות:

Emulsion for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

infectious pancreatic necrosis (IPN) virus + aeromonas + moritella + vibrio

תאריך אישור:

2022-06-24

מאפייני מוצר

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AquaVac 6 emulsion for injection for Atlantic salmon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.1 ml dose contains:
ACTIVE SUBSTANCES:
Infectious pancreatic necrosis virus (IPNV) serotype Sp, inactivated
≥ 1.5 ELISA units
1
_Aeromonas salmonicida _
subsp. s
_almonicida_
, inactivated
≥ 10.7 log
2
ELISA units
2
_Vibrio salmonicida, _
inactivated
≥ 90% RPS
3
_Listonella (Vibrio) anguillarum _
serotype O1, inactivated
≥ 75% RPS
3
_Listonella (Vibrio) anguillarum _
serotype O2a, inactivated
≥ 75% RPS
3
_Moritella viscosa_
, inactivated
≥ 6.5 log
2
ELISA units
2
1
Antigenic mass measured in the final product
2
Serological response in Atlantic salmon
3
RPS: relative percentage survival in a laboratory test in Atlantic
salmon
ADJUVANT:
Paraffin, light liquid
43 mg.
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
Polysorbate 80
Sorbitan monooleate
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
White to nearly white emulsion.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Atlantic salmon (
_Salmo salar _
L).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For active immunisation of Atlantic salmon to reduce mortality caused
by infections with IPNV
(Infectious pancreatic necrosis),
_Aeromonas salmonicida _
subsp.
_salmonicida _
(furunculosis),
_Vibrio _
_salmonicida _
(cold-water vibriosis),
_Listonella (Vibrio) anguillarum _
serotype O1 and O2a (vibriosis),
and
_Moritella viscosa _
(winter ulcer disease).
Onset of immunity: 500 degree days after vaccination for the bacterial
antigens and 608 degree days
after vaccination for IPNV.
Duration of immunity:
_A. salmonicida _
and
_M. viscosa_
:
18 months,
_L. anguillarum O1_
,
_L. anguillarum O2a _
and
_V. salmonicida_
: 16 months,
2
Infectious pancreatic necrosis virus:
4 months.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy fish only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in