ALPHA JECT micro 1 PD emulsion for injection for Atlantic salmon

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Formaldehyde inactivated culture of salmon pancreas disease virus inactivated strain al v405

Disponibil de la:

PHARMAQ AS

Codul ATC:

QI10AA01

INN (nume internaţional):

Formaldehyde inactivated culture of salmon pancreas disease virus inactivated strain al v405

Dozare:

.

Forma farmaceutică:

Emulsion for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Atlantic salmon

Zonă Terapeutică:

Salmon pancreas disease virus (SPD)

Indicații terapeutice:

Immunological - Inactivated Vaccine

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-12-04

Caracteristicilor produsului

Health Products Regulatory Authority
18 June 2021
CRN009QZ4
Page 1 of 4
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.
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.
Health Products Regulatory Authority
18 June 2021
CRN009QZ4
Page 2 of 4
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 in