Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Inactivated Salmonella Enteritidis PT4; Inactivated Salmonella Typhimurium DT 104
Boehringer Ingelheim Vetmedica GmbH
QI01AB01
Inactivated Salmonella Enteritidis PT4; Inactivated Salmonella Typhimurium DT 104
.
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
salmonella
Immunological - Inactivated Vaccine
Authorised
2007-06-22
Health Products Regulatory Authority 01 October 2020 CRN009Z3S Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Gallimune Se + St, water-in-oil emulsion for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.3-ml dose of vaccine contains: ACTIVE SUBSTANCES: Inactivated _Salmonella _Enteritidis PT4, at least..........................................................171 SAT.U Inactivated _Salmonella_ Typhimurium DT 104, at least................................................ 149 SAT.U ADJUVANT: Paraffin oil...................................................................................................................... q.s. 0.3 ml EXCIPIENT: Thiomersal, at most................................................................................................................ 30 µg The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1. SAT: Slow Agglutination Test . For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Water-in-oil emulsion for injection. White emulsion. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (layer pullets). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of layer pullets to: -reduce _Salmonella _Enteritidis dissemination in the ovary, as demonstrated 4 days after challenge; This has been tested 25 weeks after vaccination and has been demonstrated to persist until 58 weeks of age. - reduce _Salmonella _Typhimurium and _Salmonella _Enteritidis dissemination in the intestinal tract. This has been tested 4 weeks after vaccination and has been demonstrated to persist until 61 weeks of age for _Salmonella _ Typhimurium and 52 weeks of age for _Salmonella _Enteritidis. 4.3 CONTRAINDICATIONS Please refer to section 4.7 “Use during pregnancy, lactation or lay”. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Health Products Regulatory Authority 01 October 2020 CRN009Z3S Page 2 of 4 4.5 SPECIAL PRECAUTIONS Läs hela dokumentet