Aluminum in large and small volume parenterals used in total parenteral nutrition--FDA. Proposed rule.
Aluminum in large and small volume parenterals used in total parenteral nutrition--FDA. Proposed rule.
复制标题
全肠外营养中使用的大容量和小容量肠外用药中的铝 - FDA。
作者：
M. Akeson;D. N. Munns
美国食品和药物管理局(FDA)正提议修改其法规，增加某些标签要求，涉及用于全肠外营养(TPN)的大容量肠外营养(LVP)和小容量肠外营养(SVP)中的铝。FDA还提议明确LVP中允许的铝含量上限，并要求申请者开发并提交FDA批准用于测定非肠道药物产品中铝含量的有效分析方法。该机构之所以提出这些要求，是因为有证据表明，使用含铝的非肠道药物产品与接受TPN治疗的患者，特别是早产儿和肾功能受损患者的发病率和死亡率有关。
The Food and Drug Administration (FDA) is proposing to amend its regulations to add certain labeling requirements concerning aluminum in large volume parenterals (LVP's) and small volume parenterals (SVP's) used in total parenteral nutrition (TPN). FDA is also proposing to specify an upper limit of aluminum permitted in LVP's and to require applicants to develop and to submit to FDA for approval validated assay methods for determining aluminum content in parenteral drug products. The agency is proposing these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature infants and patients with impaired kidney function.