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

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Basic Information

703
22
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4.4(76)

Trade Type

Sell

Product Name

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

Manufacturer(s)

Specifications

  • Sterility: Sterile product; complies with the USP <71>/Ph.Eur. 2.6.1 sterility test
  • Bacterial Endotoxins: Complies with the pharmacopoeial bacterial endotoxin limit per USP <85>/Ph.Eur. 2.6.14 (dose-based limit)
  • Particulate Matter: Complies with USP <788>/Ph.Eur. 2.9.19 particulate matter limits for injectable/ophthalmic products
  • Container Closure Integrity: Verified by validated container-closure integrity testing (e.g., dye ingress or vacuum decay) per USP <1207>

Other Information

Additional Description:

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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