देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: VMD (Veterinary Medicines Directorate)
Salmonella enteritidis, Salmonella typhimurium
Boehringer Ingelheim Animal Health UK Ltd
QI01AB01
Salmonella enteritidis, Salmonella typhimurium
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Inactivated Bacterial Vaccine
Authorized
2007-06-11
Revised: November 2018 AN: 01034/2018 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. 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. Revised: November 2018 AN: 01034/2018 Page 2 of 5 4.3 CONTRAINDICATIONS Please refer to section 4.7 “Use during pregnancy, lactation or lay”. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. Vaccination causes a serological re पूरा दस्तावेज़ पढ़ें