药品信息:
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【英文名称】MAXIPIME Injection
【适用证】
MAXIPIME适用于治疗由指定微生物敏感菌株引起的下列感染(另见注意事项:儿科用药和剂量和用法):
---由肺炎链球菌引起的肺炎(中度至重度),包括与并发菌血症,铜绿假单胞菌,肺炎克雷伯菌或肠杆菌属相关的病例。
---发热性中性粒细胞减少症患者的经验治疗。作为单一疗法的头孢吡肟用于经验性治疗发热性中性粒细胞减少症患者。在严重感染高风险的患者中(包括近期骨髓移植史,出现低血压,潜在的恶性血液病或严重或长期中性粒细胞减少症),抗生素单药治疗可能不合适。缺乏足够的数据来支持头孢吡肟单药治疗这类患者的疗效。 (见临床研究。)
---由大肠杆菌或肺炎克雷伯氏菌引起的无并发症和复杂性尿路感染(包括肾盂肾炎),当感染严重时,或由大肠埃希菌,肺炎克雷伯菌或奇异变形杆菌引起,当感染轻度至中度时,包括与这些微生物同时发生菌血症的病例。
---无并发症的皮肤和皮肤结构由金黄色葡萄球菌(仅对甲氧西林敏感菌株)或化脓性链球菌引起的感染。
---由大肠埃希氏菌,草绿色链球菌,铜绿假单胞菌,肺炎克雷伯菌,肠杆菌属或脆弱拟杆菌引起的复杂腹腔感染(与甲硝唑联合使用)。 (见临床研究。)
【用法用量】
MAXIPIME应在约30分钟内静脉注射。
【禁忌】
MAXIPIME禁用于对头孢吡肟或头孢菌素类抗生素,青霉素或其他β-内酰胺类抗生素表现出即时超敏反应的患者。
【INDICATIONS AND USAGE 】
MAXIPIME is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION):
---Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
---Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. (See CLINICAL STUDIES.)
---Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
---Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
---Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. (See CLINICAL STUDIES.)
【CONTRAINDICATIONS 】
MAXIPIME is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta lactam antibiotics.
【DOSAGE AND ADMINISTRATION 】
The recommended adult and pediatric dosages and routes of administration are outlined in the following table. MAXIPIME should be administered intravenously over approximately 30 minutes.
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