AquaVac PD3 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, Salmon pancreas disease virus

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QI10AL

INN (שם בינלאומי):

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Salmon pancreas disease virus

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:

2015-03-26

מאפייני מוצר

Amended pages: October 2023
AN: 01481/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AquaVac PD3 emulsion for injection, for Atlantic salmon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.1 ml vaccine:
ACTIVE SUBSTANCE(S):
Salmon pancreas disease virus (SPDV) strain F93-125, ≥ 75% RPP
1
Infectious pancreatic necrosis virus (IPNV), ≥ 1.5 ELISA units
2
_Aeromonas salmonicida_ subsp. _salmonicida_, ≥ 80% RPS
60
3
1
RPP: relative percentage protection in a laboratory test in Atlantic
salmon
2
Antigenic mass measured in the final product
3
RPS: relative percentage survival at 60% control mortality in a
laboratory test in
Atlantic salmon
ADJUVANT:
Light liquid paraffin, 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 clinical signs
(heart lesions and
pancreas lesions), viremia, viral shedding and mortality from
infection with SPDV
(Pancreas disease) and to reduce mortality from infections with IPNV
(Infectious
pancreatic necrosis) and _Aeromonas salmonicida_ subsp. _salmonicida_
(furunculosis).
Onset of immunity: 500 degree days after vaccination for SPDV and
_Aeromonas _
_salmonicida_ and 540 degree days after vaccination for IPNV.
Duration of immunity: demonstrated at 15 months post vaccination for
SPDV and at
16 months post vaccination for _Aeromonas salmonicida_. Protection
against mortality
Amended pages: October 2023
AN: 01481/2023
Page 2 of 5
due to IPNV infection has been demonstrated at 4 months post
vaccination in the
field.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use in fish during smoltification.
Incorrect vaccination, stress and poor