Alpha Ject Micro 1 PD Emulsion for Injection for Atlantic Salmon

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Salmon pancreas disease virus

Disponível em:

Pharmaq AS

Código ATC:

QI10AA

DCI (Denominação Comum Internacional):

Salmon pancreas disease virus

Forma farmacêutica:

Emulsion for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Atlantic salmon

Área terapêutica:

Inactivated Viral Vaccine

Status de autorização:

Authorized

Data de autorização:

2015-12-17

Características técnicas

Revised: July 2021
AN: 01682/2020 & 01686/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALPHA JECT micro 1 PD emulsion for injection for Atlantic salmon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.05 ml) contains:
ACTIVE SUBSTANCE:
Formaldehyde inactivated culture of:
Salmon Pancreas Disease Virus (SPDV) strain AL V405
RPS
end
a
≥ 80 %
a
RPS
end
= Relative percentage survival at end control mortality in a
laboratory test in
Atlantic salmon
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 emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (_Salmo salar_ L)_ _with a minimum weight of 28 g.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of Atlantic salmon to reduce mortality,
lesions in the heart
and pancreas, and impaired growth caused by Pancreas Disease (PD).
Onset of immunity: 516 degree days.
Duration of immunity: at least 12 months.
4.3
CONTRAINDICATIONS
None.
Revised: July 2021
AN: 01682/2020 & 01686/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Fish with clinical symptoms of disease should not be vaccinated.
Vaccination should
preferably be performed at water temperatures of 15

C or lower.
Avoid vaccination during smoltification.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
The use of needle guards is recommended in order to reduce the risk of
accidental
self-injection.
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-
injection may result in severe pain and swelling, particularly if
injected into a joint or
finger, and in rare cases could result in the loss of the affected
finger if prompt
medical attention is not given. If you are accidentally injected with
this