Bioequivalence and Bioavailability Forum

Hello All,
Which model should I use for PK of Iron Sucrose Injection.

IV Bolus or IV Infusion?

Dosing section of Prescribing Information claims below
" Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session.'

Option of IV infusion given by Innovator, indirectly reflects slow intravenous injection over 2 to 5 minutes as bolus

OGD recommendation clearly states that Injection should be administered slowly accross 5 minutes.

Please Guide


If your answer is IV infusion for this particular case, then please answer below

Administration of IV bolus generally takes around 20-30 seconds in practical sense. Then what is the clear demarcation between concidering a case as IV bolus or Infusion??? I might encounter a case say 1 or 2 minute slow injection tomorrow.. Need to be ready for that too

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Edit: Category changed. [Helmut]