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hiren379 ★ India, 2013-03-26 15:23 (4430 d 00:32 ago) Posting: # 10285 Views: 4,866 |
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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  Edit: Category changed. [Helmut] |
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luvblooms ★★ India, 2013-03-28 07:17 (4428 d 08:38 ago) @ hiren379 Posting: # 10302 Views: 3,789 |
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Dear Hiren ❝ Which model should I use for PK of Iron Sucrose Injection. ❝ IV Bolus or IV Infusion? It has to be IV bolus injection (ranging from 2-5 minute). IMHO, it could be because of very short Tmax for Total Iron (10-15 min). If one is going for IV infusion this could lead to variability in the estimation and could lead to difficulty in proving bioequivalence (Personal experience, tried both the methods and Variability observed for IV infusion was almost 38% and for IV bolus it was 22%) ❝ I might encounter a case say 1 or 2 minute slow injection tomorrow.. Need to be ready for that too Have you ever thought about what the variability in the administartion rate will do the the Cmax of Total iron? One should control the adminsirtation part critically. Better to use syringe infusion pumps. Just my Two cents  — ~A happy Soul~ |
Ing. Helmut Schütz