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ANFARM HELLAS S.A. sell "Digoxin Inj.Sol. 0.25mg/ml (2ml Amp) (EU CTD Available)"

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基本信息

703
22
15
4.4(76)

交易类型

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产品名称

Digoxin Inj.Sol. 0.25mg/ml (2ml Amp) (EU CTD Available)

规格参数

  • Sterility: 无菌产品;符合USP <71>/Ph.Eur. 2.6.1无菌检查
  • Bacterial Endotoxins: 符合药典细菌内毒素限度USP <85>/Ph.Eur. 2.6.14(按剂量计算)
  • Particulate Matter: 符合USP <788>/Ph.Eur. 2.9.19注射/眼用产品微粒限度
  • Container Closure Integrity: 经过经验证的容器密封完整性测试(如染料渗透或真空衰减法)验证,符合USP <1207>

其他信息

补充描述:

Digoxin 0.25 mg/ml solution for injection (2 ml ampoule), referencing Lanoxin (GSK). Digoxin is indicated for managing chronic cardiac failure, particularly when accompanied by atrial fibrillation, and for supraventricular arrhythmias, especially chronic atrial fibrillation and flutter, where its main benefit is reducing ventricular rate; it is also used for emergency parenteral digitalization in patients who have not received cardiac glycosides in the preceding two weeks. The EU CTD dossier is available, stability studies cover Zone II and Zone IVb, shelf life is three years, batch size is 40,000 ampoules, and it is packed in cartons of 6 ampoules.
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