Šalis: Vokietija
kalba: anglų
Šaltinis: HMA (Heads of Medicines Agencies)
salmonella enteritidis inactivated 47 IU, salmonella typhimurium inactivated 116 IU
Merial Animal Health Ltd
QI01AB01
Emulsion for injection
Salmonella vaccine
Chicken Layers, Chicken Other
2012-01-13
Revised: March 2012 AN: 00482/2011 Page 1 of 5 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. Revised: March 2012 AN: 00482/2011 Pag Perskaitykite visą dokumentą