AquaVac PD3 emulsion for injection for Atlantic salmon

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated salmon pancreas disease virus; Inactivated infectious pancreatic necrosis virus; Inactivated aeromonas salmonicida subsp. salmonicida

Available from:

Intervet Ireland Limited

ATC code:

QI10AL

INN (International Name):

Inactivated salmon pancreas disease virus; Inactivated infectious pancreatic necrosis virus; Inactivated aeromonas salmonicida subsp. salmonicida

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Atlantic salmon

Therapeutic area:

Inactivated viral and inactivated bacterial vaccines

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2015-03-27

Summary of Product characteristics

Health Products Regulatory Authority
30 March 2020
CRN0098RT
Page 1 of 4
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
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.
Health Products Regulatory Authority
30 March 2020
CRN0098RT
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use in fish during smoltification.
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