Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
LIVE ATTENUATED PRRSV, STRAIN VP-046 BIS
Laboratorios Hipra S.A.
QI09AD03
LIVE ATTENUATED PRRSV, STRAIN VP-046 BIS
10(3.5) -
Lyophilisate and solvent for suspension for injection
POM
Porcine
Porcine reproductive and respiratory syndrome (PRRS) virus vaccine
Immunological - Live Vaccine
Authorised
2013-03-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: Freeze-dried powder: Active substance: Live attenuated Porcine reproductive and respiratory syndrome virus (PRRSV), strain VP-046 BIS ………………………………………………………....……………………….… 103.5-105.5 CCID50 (cell culture infectious dose) Solvent: Phosphate buffer solution. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: white to yellowish powder. Solvent: Homogeneous-clear solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Breeding females: For active immunisation of breeding females from farms affected with European PRRS virus to reduce reproductive disorders, incidence and duration of viraemia, transplacental virus transmission, virus tissue load and clinical signs associated with infection with strains of PRRS virus. Under laboratory conditions, vaccination of females reduced the negative impact of PRRS virus infection on piglet performance (mortality and weight gain) within the first 28 days of life. The onset of immunity is 30 days after vaccination and the duration of immunity is 16 weeks demonstrated by challenge. Pigs from 4 weeks of age: For active immunisation of pigs from farms affected with European PRRS virus to reduce clinical signs associated with a PRRS virus infection, the incidence and duration of viraemia and the duration of virus shedding by infected animals. Under experimental conditions, it was demonstrated that vaccination reduces the virus tissue load in th Прочитајте комплетан документ