Država: Francuska
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
streptococcus parauberis 75 % RPS
Laboratorios Hipra S. A.
QI10D
Suspension for injection
TURBOT
Fish Food
2010-05-21
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument