ICTHIOVAC-STR ESTREPTOCOCOSIS RODABALLO
Nchi: Ureno
Lugha: Kiingereza
Chanzo: HMA (Heads of Medicines Agencies)
Taarifa za kipeperushi
(PIL)
15-03-2012
Tabia za bidhaa
(SPC)
15-03-2012
Viambatanisho vya kazi:
streptococcus parauberis 75 % RPS
Inapatikana kutoka:
Laboratorios Hipra S. A.
ATC kanuni:
QI10D
Dawa fomu:
Suspension for injection
Kundi la matibabu:
TURBOT
Eneo la matibabu:
Fish Food
Idhini ya tarehe:
2010-05-21
Taarifa za kipeperushi
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ICTHIOVAC-STR ESTREPTOCOCOSIS RODABALLO (Spanish name).
ICTHIOVAC-STR STREPTOCOCCOSE TURBOT (French name)
ICTHIOVAC-STR ESTREPTOCOCOSES PREGADO (Portuguese name)
ICTHIOVAC-S
TR STREPTOCOCCOSIS ΚΑΛΚΑΝΙ (Greek name)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (0.1 ml):
ACTIVE SUBSTANCE:
Inactivated Streptococcus parauberis, strain RA-99.1
………………….. RPS
75%
Inactivated Streptococcus parauberis, strain AZ-12.1
……………….….. RPS
75%
RPS: relative percentage of survival in turbot after laboratory challenge by
intraperitoneal route.
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Species: Turbot (_Scophthalmus maximus/Psetta maxima_)
Size: 30 to 70g
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of turbots to reduce mortality associated with the infection by
_Streptococcus parauberis. _
Onset of immunity: 4 weeks (water between +14 and +18ºC).
Duration of immunity: 2 years in normal production conditions.
4.3
CONTRAINDICATIONS
See section 4.7
Do not vaccinate diseased fish or those which are carriers of any pathogenic
microorganism.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Fish should not be put under stress for the 4-5 days prior to vaccination and for the 4
weeks following vaccination
The temperature of the water should be between +14 and +18ºC. Water culture
temperature for vaccination should
Soma hati kamili
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ICTHIOVAC-STR ESTREPTOCOCOSIS RODABALLO (Spanish name).
ICTHIOVAC-STR STREPTOCOCCOSE TURBOT (French name)
ICTHIOVAC-STR ESTREPTOCOCOSES PREGADO (Portuguese name)
ICTHIOVAC-S
TR STREPTOCOCCOSIS ΚΑΛΚΑΝΙ (Greek name)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (0.1 ml):
ACTIVE SUBSTANCE:
Inactivated Streptococcus parauberis, strain RA-99.1
………………….. RPS
75%
Inactivated Streptococcus parauberis, strain AZ-12.1
……………….….. RPS
75%
RPS: relative percentage of survival in turbot after laboratory challenge by
intraperitoneal route.
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Species: Turbot (_Scophthalmus maximus/Psetta maxima_)
Size: 30 to 70g
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of turbots to reduce mortality associated with the infection by
_Streptococcus parauberis. _
Onset of immunity: 4 weeks (water between +14 and +18ºC).
Duration of immunity: 2 years in normal production conditions.
4.3
CONTRAINDICATIONS
See section 4.7
Do not vaccinate diseased fish or those which are carriers of any pathogenic
microorganism.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Fish should not be put under stress for the 4-5 days prior to vaccination and for the 4
weeks following vaccination
The temperature of the water should be between +14 and +18ºC. Water culture
temperature for vaccination should
Soma hati kamili
