Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
SALMONELLA ENTERITIDIS MUTANT, STRAIN NO 441/014, GENETICALLY STABLE, DOUBLE-ATTENUATED
IDT Biologika GmbH
QI01AE01
SALMONELLA ENTERITIDIS MUTANT, STRAIN NO 441/014, GENETICALLY STABLE, DOUBLE-ATTENUATED
Oral Lyophilisate
POM
Fowl - Chicken
Salmonella vaccine
Immunological - Live Vaccine
Authorised
2016-12-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIVAC SE. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of vaccine contains: ACTIVE SUBSTANCE: 1 to 8 x 10 8 CFU* of a double-attenuated (adenine-histidine auxotrophic) _Salmonella _Enteritidis mutant, strain 441/014. * CFU = Colony Forming Unit EXCIPIENT(S): q.s. 1 dose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for oral suspension. 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 immunization 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 02/12/2016_ _CRN 7025313_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIO Soma hati kamili