Pays: Royaume-Uni
Langue: anglais
Source: VMD (Veterinary Medicines Directorate)
Porcine respiratory and reproductive syndrome virus
MSD Animal Health UK Limited
QI09AD03
Porcine respiratory and reproductive syndrome virus
Lyophilisate for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Live Viral Vaccine
Authorized
2000-09-21
Revised: November 2023 AN: 02481/2023 Page 1 of 8 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 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- -tocopheryl acetate: 75 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: light yellow to white cake. Solvent: white solution. 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 transmission after challenge was observed in vaccinated pigs. Onset of immunity: 28 days post vaccination. Revised: November 2023 AN: 02481/2023 Page 2 of 8 Duration of immunity: 24 weeks post vaccination. 4.3 CONTRAINDICATIONS Do not use in herds where the prevalence of European PRRS virus has not been established through reliable diagnostic methods. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No data are availab Lire le document complet