Alpha Ject 2-2 Emulsion for Injection

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus

זמין מ:

Pharmaq AS

קוד ATC:

QI10AL

INN (שם בינלאומי):

Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus

טופס פרצבטיות:

Emulsion for injection

סוג מרשם:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

קבוצה תרפויטית:

Salmon (Atlantic)

איזור תרפויטי:

Inactivated Viral and Bacterial Vaccine

מצב אישור:

Expired

תאריך אישור:

2009-03-11

מאפייני מוצר

Revised: February 2014
AN. 01326/2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALPHA JECT 2-2 emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
ACTIVE SUBSTANCES:
1 dose (0.1 ml) contains:
Formaldehyde inactivated cultures of:
_Aeromonas _
_salmonicida _
subsp.
_salmonicida_
Infectious Pancreatic Necrosis Virus
(IPNV) serotype Sp
ADJUVANT:
Liquid paraffin.
EXCIPIENT:
For
the
full
list
of
excipients,
see
section 6.1
Quantitative composition
RPS
1

80 (Ph. Eur.)
RP
2
1.5 – 4.8
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (_Salmo salar _L.) of a minimum weight of 39 g
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of Atlantic salmon to prevent mortality of the
disease
caused by _Aeromonas salmonicida_ (furunculosis) and to reduce
mortality of
the disease caused by IPNV (infectious pancreatic necrosis).
The
onset
of
immunity
occurs
no
later
than
600
degree
days
from
vaccination.
1
The biological activity of one dose is given as RPS (Relative
Percentage Survival) specified
according to the Ph. Eur. monograph given above and defined by the
quotation: [1-(mortality
vaccinated fish/mortality mock vaccinated fish)] x 100.
2
Relative Potency
Revised: February 2014
AN. 01326/2013
Page 2 of 6
The protection against_ Aeromonas salmonicida _lasts for at least 12
months
post vaccination. Protection against IPNV has been demonstrated for up
to
two and a half months in field trials performed with a vaccine
containing IPNV
and additional antigens to those found in ALPHA JECT 2-2.
4.3
CONTRAINDICATIONS
Confer section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
An immunisation period of at least 600 degree-days from vaccination to
transfer to seawater is recommended.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not administer this product to fish which have already received
this
vaccine. Fish with clinical sig