Alpha Ject Micro 6 Emulsion for Injection for Atlantic Salmon

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Listonella anguillarum, Moritella viscosa, Vibrio salmonicida

Fáanlegur frá:

Pharmaq AS

ATC númer:

QI10AL

INN (Alþjóðlegt nafn):

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Listonella anguillarum, Moritella viscosa, Vibrio salmonicida

Lyfjaform:

Emulsion for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Atlantic salmon

Lækningarsvæði:

Inactivated Viral and Bacterial Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

2019-03-15

Vara einkenni

Unlimited Renewal: June 2023
AN: 00698/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISITCS
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).
Unlimited Renewal: June 2023
AN: 00698/2023
Page 2 of 6
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 PRECAUTIO