Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DOUBLE-ATTENUATED (ADENINE-HISTIDINE AUXOTROPHIC) SALMONELLA ENTERTIDIS MUTANT STRAIN 441/014
IDT Biologika GmbH
QI01AE01
DOUBLE-ATTENUATED (ADENINE-HISTIDINE AUXOTROPHIC) SALMONELLA ENTERTIDIS MUTANT STRAIN 441/014
Oral Lyophilisate
POM
Fowl - Chicken
Salmonella vaccine
Immunological - Live Vaccine
Authorised
2016-03-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT SALMOVAC 440 Lyophilisate for use in drinking water 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of vaccine contains: ACTIVE SUBSTANCE: Double-attenuated (adenine-histidine auxotrophic) _Salmonella _Enteritidis mutant, strain 441/014 1-8 x 10 8 CFU* * CFU = Colony Forming Unit EXCIPIENT(S): q.s. 1 dose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for use in drinking water. Light beige to brownish light gray lyophilisate. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens from one day old (breeders and layers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of chickens to reduce colonization, persistence and invasion of the intestinal tract and internal organs by _Salmonella _Enteritidis and _Salmonella _Typhimurium. Onset of immunity within 6 days after first vaccination. Duration of immunity for _Salmonella _Enteritidis is 35 weeks after second vaccination and 63 weeks after third vaccination when used according to the recommended vaccination schedule. Duration of immunity for _Salmonella _Typhimurium is 60 weeks after third vaccination when used according to the recommended vaccination schedule. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy chickens or chickens under heavy stress conditions. Do not use in broilers. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinated chickens excrete the vaccine strain up to six weeks post vaccination. The vaccine may thus spread to susceptible birds in contact with vaccinated chickens or their manure. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 11/03/2016_ _CRN 7021823_ _page number: 1_ 4.5 SPECIAL Přečtěte si celý dokument