Efficacy of Romet 30 to control mortality against enteric redmouth disease caused by Yersinia ruckeri in freshwater-reared rainbow trout (Oncorhynchus mykiss).

磺胺二甲氧嘧啶与甲氧苄氨嘧啶联合治疗彩虹的药效研究 旅游研究策略 摘要 Pharmaq AS持有磺胺二甲氧嘧啶和甲氧嘧啶(ROMET 30)，饲料中使用的A类药物制品。当前的标签指示是针对 鲑鱼对气单胞菌引起的腐殖病死亡率的控制 沙门氏菌和通道内沙门氏菌抗爱德华氏菌引起的肠道败血症 伊克塔鲁里。Pharmaq AS希望扩大NADA 125933的标签适应症。我们 FDA兽医中心的药品注册要求包括临床领域 对拟议的标签指示的有效性进行研究。 这项研究将遵循2019年12月4日提交的拟议研究方案， 题为《Romet®30(磺胺二甲氧嘧啶和甲氧苄氨嘧啶A型)的疗效》 药物制品)在饲料中给药以控制易感病引起的死亡 淡水养殖鳍鱼的细菌病原体。具体来说，这项研究将评估 该药对沙门氏耶尔森氏菌引起的肠道红口病的疗效观察 虹鲑鱼(Oncorhynchus MykISS)。这项研究将在以下分项奖励下进行 美国鱼类和野生动物服务，水生动物药物批准伙伴关系，博兹曼， 蒙大拿州在一个经过适当审查的地点经历了一次自然流行性传染病。

SULFADIMETHOXINE AND ORMETOPRIM – FIELD EFFECTIVENESS STUDY IN RAINBOW TROUT.RESEARCH STRATEGY Summary PHARMAQ AS holds NADA 125933 for Sulfadimethoxine and Ormetoprim (Romet® 30), a Type A Medicated Article for use in feed. Current label indications are for the control of mortality in salmonids against furunculosis disease caused by Aeromonas salmonicida and in channel catifhs against enteric septicemia caused by Edwardsiella ictaluri. PHARMAQ AS desires to expand the label indications for NADA 125933. US FDA Center for Veterinary Medicine drug registration requirements include clinical field studies to address effectiveness of a proposed label indication. The study will follow the proposed study protocol submitted on December 4, 2019, entitled “The Efficacy of Romet® 30 (sulfadimethoxine and ormetoprim Type A medicated article) Administered in Feed to control mortality caused by susceptible bacterial pathogens of freshwater-reared finfish. Specifically, this study will assess the effectiveness of the drug against enteric redmouth disease caused by Yersinia ruckeri in rainbow trout (Oncorhynchus mykiss). The study will be conducted under subaward by US Fish and Wildlife Services, Aquatic Animal Drug Approval Partnership, Bozeman, Montana at an appropriately vetted site undergoing a natural epizootic.