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Normocarb: Next-Gen Dialysis Solutions at PCRRT Conference 2008

Learn about Normocarb's milestones and therapeutic evolution, featuring key electrolytes in physiologically correct concentrations. Discover Normocarb HF's simple preparation and flexibility, with options to add potassium, calcium, and dextrose.

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Normocarb: Next-Gen Dialysis Solutions at PCRRT Conference 2008

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  1. DIALYSIS SOLUTIONS INC. PCRRT Conference Orlando, FL June 20th, 2008

  2. CVVH: Bicarbonate vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000

  3. CVVH: Bicarb vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000 Dark bar = Bicarb Light bar = lactate

  4. Normocarb HF • CRRT SHOULD FIX METABOLIC DISTURBANCES, NOT CAUSE THEM. • Normocarb is the right formulation to provide key electrolytes in the physiologically correct concentrations with no unnecessary components and maximum flexibility.

  5. DSI Milestones • 1999 – Original Patent for NC35 applied for • 2001July – Walter O’Rourke joins as consultant • 2001 December – Normocarb receives FDA 510K approval as device • 2002January – DSI records first US sales of Normocarb • 2002 June – Pediatric Nephrology: Pediatric Hemofiltration: Normocarb Dialysate Solution with Citrate Anticoagulation; Bunchman • 2002 June – BBraun agreement signed • 2002 July – Normocarb receives Canadian DIN • 2003 June – Journal of Critical Care: A Novel Regional Citrate Anticoagulation Protocol for CRRT Using Only Commercially Available Solutions; Tobe

  6. DSI Milestones • 2003 December – AJKD: Pediatric Convective Hemofiltration: Normocarb Replacement and Citrate Anticoagulation; Bunchman • 2005 August – FDA grants Orphan Drug Status to the CRRT indication based on DSI’s application • 2006 January – FDA 510K Approval for NC25 • 2006 May – Canadian Patent issued on NC25 • 2006 July – DSI receives an NDA for NC25HF/NC35HF • 2006 November – DSI launches HF Products • 2007 August – DSI receives US patent for 25 bicarb products

  7. Therapy Evolution • Diffusion based dialysis requiring device or combination product approved solutions • Citrate • Hemofiltration dialysis requiring drug approved solutions • Volume

  8. Solution Evolution • Lactate Buffered – PD Solutions – Dialysate • Pharmacy Made – Calcium Containing – Bicarbonate Solutions – Dialysate • Citrate • Pharmacy Made – Calcium Free – Bicarbonate Solutions – Dialysate • Add Mixture Pharmacy Solutions – Calcium Free – Bicarbonate – Dialysate • Normocarb – Calcium Free – Dialysate • Normocarb NDA as hemofiltration solution for direct infusion

  9. Normocarb HF • Dialysate vs. Hemofiltration Solution

  10. Normocarb 35 HF • NC 35 HF • mEq/L • Sodium (Na) 140 • Magnesium (Mg) 1.5 • Chloride (Cl) 106.5 • Bicarbonate (HCO3) 35 • Potassium (K) 0 • Calcium (Ca) 0

  11. Normocarb 25 HF • NC 25 HF • mEq/L • Sodium (Na) 140 • Magnesium (Mg) 1.5 • Chloride (Cl) 116.5 • Bicarbonate (HCO3) 25 • Potassium (K) 0 • Calcium (Ca) 0

  12. Normocarb HF • Simple Preparation • Maximum Flexibility • Potassium can be added. • Calcium can be added • Dextrose can be added

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