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:

2022-08-08

מאפייני מוצר

Revised: April 2024
AN: 02631/2023
Page 1 of 5
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 dose of 0.1 ml 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White to nearly white emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (_Salmo salar_ L).
4.2
INDICATIONS FOR USE, SPECIFYING THE 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).
Revised: April 2024
AN: 02631/2023
Page 2 of 5
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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy fish only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for