Veterinary Medicine Information website

ALPHA JECT micro 5, emulsion for injection for Atlantic salmon.

Authorised
  • Moritella viscosa, Inactivated
  • Aliivibrio salmonicida, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
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Product identification

Medicine name:
ALPHA JECT micro 5, emulsion for injection for Atlantic salmon.
Active substance:
  • Moritella viscosa, Inactivated
  • Aliivibrio salmonicida, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
Target species:
  • Atlantic salmon
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Moritella viscosa, Inactivated
    10.70
    log2 enzyme-linked immunosorbent assay unit(s)
    /
    0.05
    millilitre(s)
  • Aliivibrio salmonicida, Inactivated
    90.00
    Relative Percentage Survival
    /
    0.05
    millilitre(s)
  • Vibrio anguillarum, serotype O2a, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.05
    millilitre(s)
  • Vibrio anguillarum, serotype O1, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.05
    millilitre(s)
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
    12.60
    log2 enzyme-linked immunosorbent assay unit(s)
    /
    0.05
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Atlantic salmon
      • Fish meat
        0
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10AB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
Package description:
  • 10 x 500 ml injection bags made of a multilayer plastic foil with inner layer of ethylene vinyl acetate (EVA). The giving port is closed with a bromobutyl rubber stopper.
  • 500 ml injection bags made of a multilayer plastic foil with inner layer of ethylene vinyl acetate (EVA). The giving port is closed with a bromobutyl rubber stopper.
  • 250 ml injection bags made of a multilayer plastic foil with inner layer of ethylene vinyl acetate (EVA). The giving port is closed with a bromobutyl rubber stopper.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Pharmaq AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmaq AS
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 21-14286
Date of authorisation status change:
Reference member state:
  • Norway
Procedure number:
  • NO/V/0017/001
Concerned member states:
  • Iceland

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 3/07/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 3/07/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 6/10/2023
Updated on: 7/10/2023
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Combined File of all Documents

English (PDF)
Published on: 22/03/2024
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