Norvax compact PD emulsion for injection for Atlantic salmon

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmon pancreas disease virus (spdv) strain f93-125

Available from:

Intervet Ireland Limited

ATC code:

QI10AA01

INN (International Name):

Salmon pancreas disease virus (spdv) strain f93-125

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Atlantic salmon

Therapeutic area:

Salmon pancreas disease virus (SPD)

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2011-08-19

Summary of Product characteristics

Registration file / May 2022
Confidential
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NORVAX COMPACT PD emulsion for injection for Atlantic salmon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.1 ml contains:
ACTIVE SUBSTANCE:
Inactivated salmon pancreas disease virus (SPDV) strain F93-125, ≥
70% RPP*
* RPP: relative percentage protection in a laboratory potency test in
Atlantic salmon
ADJUVANT:
Montanide ISA 763A VG 63 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Homogenous, white to slightly pink emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (
_Salmo salar_
L)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of Atlantic salmon to reduce heart
lesions, mortality and weight loss caused
by pancreas disease.
Onset of immunity: 500 degree days.
Duration of immunity: at least 12 months for reduction of heart
lesions and 18 months for reduction of
mortality and weight loss.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine should not be used in diseased or unhealthy fish, fish
receiving medical treatment or fish
during smoltification.
Vaccine efficacy at temperatures below 10 °C has not been documented.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccination at higher water temperatures (exceeding 17 °C) can
increase local reactions.
Vaccination of fish below the recommended weight may increase local
reactions.
Registration file / May 2022
Confidential
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Personal protective equipment consisting of e.g. needle protector
should be used when handling the
product.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the
label to the physician.
To the user:
This veterinary medicinal product contains mineral oil (Montanide).
Accidental injection/self-injection
may result in seve