Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Modified live porcine respiratory and reproductive syndrome virus
Zoetis Belgium SA
QI09AD03
porcine respiratory and reproductive syndrome virus, live
Pigs
Immunologicals for suidae, Live viral vaccines
For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1).Fattening pigs: In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. Vaccination of seronegative 2-week-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination.Gilts and sows: In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, either seropositive or seronegative, was demonstrated to reduce the transplacental infection caused by PRRS virus during the third trimester of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and at weaning, of lung lesions and of viral load in lungs in piglets at weaning).
Revision: 4
Authorised
2017-08-24
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: SUVAXYN PRRS MLV LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorization holder and manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (2 ml) contains: Lyophilisate: ACTIVE SUBSTANCE: Modified live PRRSV*, strain 96V198: 10 2.2 – 10 5.2 CCID 50 ** * Porcine respiratory and reproductive syndrome virus ** Cell culture infectious dose 50% Solvent: Sodium chloride 0.9% solution: qs 1 dose. Lyophilisate: off-white freeze-dried pellet. Solvent: clear, colourless solution. 4. INDICATION(S) For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1). Onset of immunity: 21 days after vaccination. Duration of immunity: 26 weeks after vaccination. Fattening pigs: In addition, vaccination of seronegative 1 day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. Vaccination of seronegative 2 weeks-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post vaccination. 20 Gilts and sows: In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or exposed to PRRS virus via field infection) or PRRS virus-naïve, was demonstrated to reduce the transplacental infection caused by PRRS viru Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: Lyophilisate: ACTIVE SUBSTANCE: Modified live PRRSV*, strain 96V198: 10 2.2 – 10 5.2 CCID 50 ** * Porcine respiratory and reproductive syndrome virus ** Cell culture infectious dose 50% Solvent: Sodium chloride 0.9% solution: qs 1 dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: off-white freeze-dried pellet. Solvent: clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (pigs for fattening, gilts and sows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1). Onset of immunity: 21 days after vaccination. Duration of immunity: 26 weeks after vaccination. Fattening pigs: In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. Vaccination of seronegative 2-week-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination. Gilts and sows: In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or exposed to PRRS virus via field 3 infection) or PRRS virus-naïve, was demonstrated to reduce the transplacental infection caused by PRRS virus during the last third of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence Lestu allt skjalið