Efficacy of Romet 30 to control mortality against enteric redmouth disease caused by Yersinia ruckeri in freshwater-reared non-rainbow trout salmonid.

Romet 30 控制淡水养殖非虹鳟鱼鲑鱼中由鲁氏耶尔森氏菌引起的肠道红口病死亡率的功效。

• 批准号: 10086714
• 负责人: Thomas D Goodrich
• 金额: $ 5.77万
• 依托单位: AQUA TACTICS FISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10086714
• 关键词: Efficacy; Romet; 30; control; mortality

SULFADIMETHOXINE AND ORMETOPRIM – FIELD EFFECTIVENESS STUDY IN NON- 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 a non-rainbow trout salmonid. 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.

磺胺二甲氧嘧啶和奥美托匹林-在非 彩虹山雀研究策略 总结 PHARMAQ AS持有磺胺二甲氧嘧啶和奥美托嘧啶（Romet®）的NADA 125933 30），一种用于饲料的A类含药制品。当前标签适应症适用于 气单胞菌引起疖病对鲑鱼死亡率的控制 杀鲑素和通道内毒素对爱德华氏菌引起肠败血症的作用 伊克他鲁PHARMAQ AS希望扩展NADA 125933的标签适应症。美国 FDA兽药中心的药品注册要求包括临床领域 旨在说明拟定标签适应症有效性的研究。 本研究将遵循2019年12月4日提交的拟定研究方案。 标题为“Romet® 30（磺胺二甲氧嘧啶和甲氧苄氨嘧啶A型）的疗效 含药物品）在饲料中给药，以控制由易感动物引起的死亡 淡水养殖有鳍鱼的细菌病原体。具体而言，本研究将评估 药物对鲁氏耶尔森氏菌引起的肠红口病的疗效观察 一种非虹鳟鲑。这项研究将由美国鱼类协会（US Fish）分授 和野生动物服务部，水生动物药物批准合作伙伴关系，蒙大拿州博兹曼，地址： 一个经过适当审查的自然流行区。