ALPHA JECT micro 6 emulsion for injection for atlantic salmon

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

infectious pancreatic necrosis virus, inactivated; Listonella anguillarum serotype o2a; al 104; Listonella anguillarum serotype O1; AL 112; Aeromonas salmonicida subsp. salmonicida, al 2017; Moritella viscosa, al 266; Vibrio salmonicida al 1134

Tillgänglig från:

PHARMAQ AS

ATC-kod:

QI10AL02

INN (International namn):

infectious pancreatic necrosis virus, inactivated; Listonella anguillarum serotype o2a; al 104; Listonella anguillarum serotype O1; AL 112; Aeromonas salmonicida subsp. salmonicida, al 2017; Moritella viscosa, al 266; Vibrio salmonicida al 1134

Dos:

.

Läkemedelsform:

Emulsion for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

infectious pancreatic necrosis (IPN) virus + aeromonas + moritella + vibrio

Bemyndigande status:

Authorised

Tillstånd datum:

2019-03-15

Produktens egenskaper

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALPHA JECT micro 6 emulsion for injection for Atlantic salmon.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.05 ml) contains:
ACTIVE SUBSTANCES:
Formaldehyde inactivated cultures of:
_Aeromonas salmonicida _
subsp.
_salmonicida _
> 12.6 log
2
ELISA units
_Listonella anguillarum_
*
serotype O1
RPS ≥ 75 %
_Listonella anguillarum_
*
serotype O2a
RPS ≥ 75 %
_Vibrio salmonicida _
RPS ≥ 90 %
_Moritella viscosa _
> 10.7 log
2
ELISA units
Infectious Pancreatic Necrosis Virus serotype Sp
0.12-0.28 AU
ELISA units: Serological response in Atlantic salmon,
RPS: Relative Percentage Survival is based on results from challenge
studies on Atlantic salmon at 60% mortality in the control group.
AU: Antigenicity Units (quantity of virus antigen measured in the
final product).
*
_Listonella anguilllarum _
is synonymous with
_Vibrio anguillarum._
ADJUVANT:
Paraffin, light liquid (mineral oil): 23 mg.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White to cream coloured.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (
_Salmo salar_
) of a minimum weight of 25 g.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of Atlantic salmon to reduce mortality caused
by infections with
_Aeromonas _
_salmonicida _
(furunculosis),
_Vibrio salmonicida _
(coldwater vibriosis),
_Listonella anguillarum _
serotype
O1and O2a (classical vibriosis),
_Moritella viscosa _
(winter sore) and IPNV (infectious pancreatic
necrosis).
Onset of immunity:
520 degree days post vaccination for the bacterial antigens and
600 degree days post vaccination for IPNV.
Duration of immunity: 12 months for the bacterial antigens and 5.5
months for IPNV.
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 use in animals
Vaccination should preferably be performed at water temperatures of
15°C or below.
Do not vacc