ALPHA JECT 3000 EMULSION FOR INJECTION FOR ATLANTIC SALMON

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AEROMONAS SALMONICIDA SUBSP. SALMONICIDA, AL 2017, LISTONELLA ANGUILLARUM SEROTYPE O1; AL 112, LISTONELLA ANGUILLARUM SEROTYPE O2A; AL 104

Available from:

PHARMAQ AS

ATC code:

QI10AB02

INN (International Name):

AEROMONAS SALMONICIDA SUBSP. SALMONICIDA, AL 2017, LISTONELLA ANGUILLARUM SEROTYPE O1; AL 112, LISTONELLA ANGUILLARUM SEROTYPE O

Dosage:

Unknown

Pharmaceutical form:

Emulsion for Injection

Prescription type:

POM

Therapeutic group:

Fish - (Atlantic) Salmon

Therapeutic area:

Aeromonas vaccine + Vibrio vaccine

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2002-10-01

Summary of Product characteristics

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:
Formaldehyde inactivated bacteria cultures of:
_Aeromonas salmonicida_
subsp. _salmonicida; _AL 2017
*RPS
>
80 (Ph. Eur.)
_Listonella anguillarum _serotype O1; AL 112
*RPS
>
75 (Ph. Eur.)
_Listonella anguillarum _serotype O2a; AL 104
*RPS
>
75 (Ph. Eur.)
ADJUVANT:
Liquid paraffin
EXCIPIENTS
For a full list of excipients, see section 6.1.
*RPS: Relative Percent Survival: The biological activity of one dose is given as RPS
60
specified for each antigen
according to the respective Ph. Eur. monograph, defined by the quotation: [1-(% mortality vaccinated fish/60%
mortality in control fish)] x 100.
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 _Listonella anguillarum_
_s_erotype O1 and O2a (vibriosis) in Atlantic salmon.
The onset of immunity occurs 450 degree days post vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 08/09/2014_
_CRN 7016984_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Do not administer this product to fish, which have already received this vaccine. Fish with clinical symptoms of
disease should not be vaccinated.
Do not vaccinate at water temperatures below 3
°
C and