ALPHA JECT 3000 Emulsion for injection for Atlantic salmon

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Aeromonas salmonicida subspecies Salmonicida; AL 2017; Listonella anguillarum serotype O1; AL 112; Listonella anguillarum serotype o2a; al 104

Verfügbar ab:

PHARMAQ AS

ATC-Code:

QI10AB02

INN (Internationale Bezeichnung):

Aeromonas salmonicida subspecies Salmonicida; AL 2017; Listonella anguillarum serotype O1; AL 112; Listonella anguillarum serotype o2a; al 104

Dosierung:

.

Darreichungsform:

Emulsion for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Atlantic salmon

Therapiebereich:

aeromonas + vibrio

Anwendungsgebiete:

Immunological - Inactivated Vaccine

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2002-10-01

Fachinformation

Health Products Regulatory Authority
07 January 2022
CRN00CQXC
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ALPHA JECT 3000 Emulsion for injection for Atlantic salmon
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S):
1 dose (0.1 ml) contains:
ACTIVE SUBSTANCES:
Formaldehyde inactivated bacteria cultures of:
_Aeromonas salmonicida_
subsp. _salmonicida;_ AL 2017 RPS
1
> 70
_Listonella anguillarum _serotype O1; AL 112 RPS
2
> 75
_Listonella anguillarum _serotype O2a; AL 104 RPS
2
> 75
RPS: Relative Percentage Survival is based on results from challenge
studies on Atlantic salmon at end
1
or 60%
2
mortality in the
control group.
ADJUVANT:
Paraffin, light liquid (mineral oil): 46 mg
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection.
White to cream coloured homogeneous emulsion when shaken.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Atlantic salmon (_Salmo salar_) of a minimum weight of 15 g.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of mortality by the diseases caused by _Aeromonas
salmonicida_ (furunculosis) and _Listonellaanguillarum s_erotype O1
and O2a (vibriosis) in Atlantic salmon.
Onset of immunity occurs :450 degree days post vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Health Products Regulatory Authority
07 January 2022
CRN00CQXC
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not administer this product to fish, which have already received
this vaccine. .
Do not vaccinate at water temperatures below 3 °C and above 18 °C.
Temperatures close to 18 °C are suboptimal for Atlantic
salmon, thus vaccination should preferably be performed at water
temperatures of 15 °C or below. Avoid vaccination during
smoltification.
The severity of adverse reactions is among different factors dependent
upon sanitation, vaccination technique, fish size at
vaccination and water tempe