国: アイルランド
言語: 英語
ソース: 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: Prescription Only Medicine as defined in relevant national legislation
Chickens
salmonella
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ 完全なドキュメントを読む