Aquavac 6 Emulsion for Injection for Atlantic Salmon

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Listonella anguillarum, Moritella viscosa, Vibrio salmonicida

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QI10AL02

INN (שם בינלאומי):

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Listonella anguillarum, Moritella viscosa, Vibrio salmonicida

טופס פרצבטיות:

Emulsion for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Atlantic salmon

איזור תרפויטי:

Inactivated Viral and Bacterial Vaccine

מצב אישור:

Authorized

תאריך אישור:

2022-05-24

מאפייני מוצר

Revised: May 2024
AN: 04044/2022 & 02522/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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. _salmonicida_, 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).
Revised: May 2024
AN: 04044/2022 & 02522/2023
Page 2 of 6
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
Infectious pancreatic necrosis virus:
4 months
3.3
CONTRAIN