Birnagen Forte As Emulsion for Injection for Atlantic Salmon

Summary of Product characteristics

                                Revised: May 2013
AN: 00228/2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Birnagen Forte As Emulsion for Injection for Atlantic Salmon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
1 dose (0.1 ml) contains:
Inactivated _Aeromonas salmonicida_ (As27)
RPS
60
* ≥80%
Inactivated Infectious Pancreatic Necrosis
RP** ≥ 1.22
Virus (IPNV)
*
RPS
60
: Relative Percent Survival
**
RP: relative potency compared to a reference vaccine.
ADJUVANT
Mineral oil (Drakeol 6VR)
43.62%
EXCIPIENTS
Formaldehyde (residual inactivant)
< 0.5% (w/v)
See section 6.1 for a complete list of excipients
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (_Salmo salar_) weighing at least 35 g.
4.2
INDICATIONS FOR USE
For the active immunisation of Atlantic salmon (_Salmo salar_) to
prevent mortality due to
infection with _Aeromonas salmonicida_ (furunculosis).
The onset of immunity to _A. salmonicida_ is no later than 430 degree
days following
vaccination.
The duration of immunity to _A. salmonicida_ has been demonstrated up
to 2000 degree
days following vaccination.
Revised: May 2013
AN: 00228/2013
Page 2 of 5
For the active immunisation of Atlantic salmon to reduce clinical
signs and mortality due
to infection with Infectious Pancreatic Necrosis Virus (IPNV).
In laboratory trials, the onset of immunity to IPNV has been shown to
be no later than
771 degree days following vaccination.
In field trials, the vaccine has been shown to reduce mortality
compared to controls in
the face of IPNV challenge after transfer to sea 600 degree days after
vaccination.
4.3
CONTRAINDICATIONS
Do not use if there are any signs of furunculosis or IPNV disease in
the fish. See
section 4.7.
4.4
SPECIAL WARNINGS
Vaccinate only healthy fish. It is recommended that all fish within
the stock population
are vaccinated in order to reduce infection spread.
Fish should be starved for a period of at least 24 hours and
preferably 48 hours prior to
vaccinat
                                
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