Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
INACTIVATED SALMONELLA ENTERITIDIS PT4, AT LEAST, INACTIVATED SALMONELLA TYPHIMURIUM DT 104, AT LEAST
Merial Animal Health Limited
QI01AB01
INACTIVATED SALMONELLA ENTERITIDIS PT4, AT LEAST, INACTIVATED SALMONELLA TYPHIMURIUM DT 104, AT LEAST
Unknown
Emulsion for Injection
POM
Fowl - Chicken
Salmonella vaccine
Immunological - Inactivated vaccine
Authorised
2007-06-22
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 E Read the complete document