Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Porcine reproductive respiratory syndrome (prrs) virus strain dv live
Intervet Ireland Limited
QI09AD03
Porcine reproductive respiratory syndrome (prrs) virus strain dv live
.
Lyophilisate and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
porcine reproductive and respiratory syndrome (PRRS) virus
Immunological - Live Vaccine
Authorised
2003-06-06
1 September 2021 SUMMARY OF PRODUCT CHARACTERISTICS 2 June 2022 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PRRS lyophilisate and solvent for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml (intramuscular injection) or 0.2 ml (intradermal application) of reconstituted vaccine contains: Lyophilisate: ACTIVE SUBSTANCE: Live attenuated PRRS virus strain DV: 10 4.0 - 10 6.3 TCID 50 * * tissue culture infective dose 50 % Solvent: ADJUVANT: dl- α -tocopheryl acetate: 75 mg/ml EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _ _Lyophilisate:_ culture medium chemically defined stabiliser CD#279 (patented) _Solvent: _ polysorbate 80 _ _ sodium chloride _ _ potassium dihydrogen phosphate _ _ disodium phosphate dihydrate _ _ simethicone _ _ water for injection Lyophilisate: light yellow to white cake. Solvent: white solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus. SPECIFIC CLAIMS 3 June 2022 For finishing pigs, the effect of the virus on the respiratory system is most relevant. A significant improvement of rearing results (reduced morbidity due to PRRS infection, and a better daily growth and feed conversion) until the end of the fattening period was observed in vaccinated pigs during field trials, particularly in piglets vaccinated at 6 weeks of age. For breeding pigs, the effect of the virus on the reproductive system is most relevant. A significant improvement of the reproductive performance in PRRS virus contaminated environments and a reduction of transplacental virus transmission after challenge was observed in vaccinated pigs. Onset of immunity: 28 days post vaccination. Duration of immunity: 24 weeks post vaccination. 3.3 CONTRAINDICATIONS Do not use in herds where the prevalence of European PRRS virus has not b Leggi il documento completo