Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
LIVE ATTENUATED PRRS 94881 VIRUS
Boehringer Ingelheim Ltd
QI09AD03
LIVE ATTENUATED PRRS 94881 VIRUS
10
Lyophilisate + solvent for suspension
POM
Porcine
Porcine reproductive and respiratory syndrome (PRRS) virus vaccine
Immunological - Live Vaccine
Authorised
2015-04-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT ReproCyc PRRS EU lyophilisate and solvent for suspension for injection for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: Lyophilisate: ACTIVE SUBSTANCE Live attenuated Porcine Respiratory and Reproductive Syndrome Virus (PRRSV), strain 94881 (genotype 1) At least: 10 TCID 10 TCID *Tissue Culture Infectious Dose 50 Solvent: ADJUVANT Carbomer: 2.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: off-white to milky grey Solvent: clear, colourless solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (breeding females) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of breeding females from farms affected with European (genotype 1) Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) to reduce the duration of viraemia, the proportion of viraemic gilts/sows and viral loads in blood after exposure to PRRSV as shown under experimental conditions. Onset of immunity: 4 weeks Duration of immunity: 17 weeks Vaccination of breeding females according to the recommended schedule described in section 4.9 reduces the negative reproductive disorders associated with PRRSV. Under experimental challenge conditions a reduction in transplacental virus transmission after challenge was additionally demonstrated. In piglets from vaccinated sows, a reduction in the negative impact of PRRS virus infection (mortality, clinical signs and weight gain) was also demonstrated during the first 20 days of life. 3.9 50 - 7.0 50 * H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Olvassa el a teljes dokumentumot