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Imipenem/cilastatin sodium/relebactam fixed combination to treat urinary infections and complicated intra-abdominal bacterial infections

机译:Imipenem / Cilastatin钠/重新纳米固定组合治疗尿感染和复杂的腹内细菌感染

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摘要

Imipenem/cilastatin sodium/relebactam is a combination of imipenem/cilastatin, a U.S. Food and Drug Administration (FDA)-approved antibiotic, and beta-lactamase inhibitor relebactam which has been developed for the treatment of complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) due to drug-resistant bacterial pathogens. The combination (Recarbrio) has been designated as a qualified infectious disease product (QIDP) and obtained FDA approval in 2019 for the treatment of cUTI and cIAI caused by susceptible Gram-negative microorganisms in adult patients with limited or no alternative treatment options. The product was also approved by the European Medicines Agency (EMA) in 2020 for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
机译:Imipenem / Cilastatin钠/重新纳米酸酐是亚联器/西兰拉汀,美国食品和药物管理局(FDA) - 批准的抗生素和β-内酰胺酶抑制剂重新分裂的组合,其已经开发出用于治疗复杂的泌尿道感染(CUTI)和复杂的复杂性 由于耐药细菌病原体,腹腔内感染(CIAI)。 组合(RECARBRIO)被指定为合格的传染病产品(QIDP),并在2019年获得FDA批准,用于治疗成人患者有限或无替代治疗方案的成年患者患者敏感的革兰氏阴性微生物引起的CURI和CIAI。 该产品还由欧洲药物局(EMA)批准2020年,用于治疗有氧革兰阴性生物的感染,治疗方案有限。

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