দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: 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
*** AWAITING VALUE ***
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
salmonella
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 EACH TARGET SPECIES None. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ সম্পূর্ণ নথি পড়ুন