Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: HMA (Heads of Medicines Agencies)
Intervet Intenational BV
2011-12-16
Revised: December 2011 AN: 00178/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PRRS Lyophilisate and solvent for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 2 ml (intramuscular application) or 0.2 ml (intradermal application) of reconstituted vaccine: Lyophilisate: ACTIVE SUBSTANCE: Live attenuated PRRS virus strain DV: 10 4.0 - 10 6.3 TCID 50 * Solvent (Diluvac Forte): ADJUVANT: dl- -tocopheryl acetate: 75 mg/ml For a full list of excipients, see section 6.1. * tissue culture infective dose 50 % 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE 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 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 trans Lue koko asiakirja