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Bicarby™ Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).

The Bicarby Dialysate solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (select solutions), sodium bicarbonate, and glucose. One (1) new calcium-containing solution and seven (7) new calcium-free solutions are being introduced. Of the 7 calcium-free solutions, there are only four (4) unique formulations (Table 1).

Bicarby Dialysate solutions are sterile dialysates for use in KRT. The solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing solutions are designed for modalities using heparin anticoagulation, while the calcium-free solutions are intended for modalities using regional citrate anticoagulation (RCA). The calcium-free solutions sustain the anticoagulatory effect of citrate in the filter. Therefore, a separate infusion of calcium is mandatory when using these solutions.

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