INTENDED USE STATEMENTS

INDICATIONS AND IMPORTANT RISK INFORMATION

PHOXILLUM RENAL REPLACEMENT SOLUTION

Indications

PHOXILLUM Renal Replacement Solution is indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. It may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Important Risk Information

PHOXILLUM Solution can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately. PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis. PHOXILLUM solution can effect blood glucose levels resulting in hypo- or hyper-glycemia depending upon dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or other corrective measures during treatment.

Full Prescribing Information

PRISMASOL Renal Replacement Solution

Indications

PRISMASOL Renal Replacement Solution is indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolytes and acid-base imbalances. PRISMASOL Solution may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances

Important Risk Information
  • PRISMASOL Renal Replacement Solution is contraindicated in patients with known hypersensitivities to this product.
  • PRISMASOL Solution can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately. The use of PRISMASOL Solutions containing dextrose may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation of or modification of antidiabetic therapy during treatment with PRISMASOL Solutions containing dextrose. Monitor blood glucose.

Full Prescribing Information

The PRISMAFLEX Control Unit is intended for:

  • Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
  • Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where fluid removal of plasma components is indicated.

PRISMASATE

PrismaSATE Dialysate Formula is intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. It may also be used in case of drug poisoning with dialyzable or filterable substances.

PRISMAFLO IIS BLOOD WARMER

Indications

The PRISMAFLO IIS Blood Warmer is used to transfer heat to the return blood during a PRISMAFLEX System Treatment.

The PRISMAX System is intended for:

  • Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
  • Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where fluid removal of plasma components is indicated.

PRISMAFLEX SYSTEM HF1000/HF1400 SETS

Indications

The PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.

All treatments administered via the PRISMAFLEX Set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.

The PRISMAFLEX HF1000/HF1400 sets should be restricted to patients with a body weight greater than 30 kg (66 lb).

The HF1000 and HF1400 hemofilter sets are designed for prescription flexibility on the PRISMAFLEX System. Both set configurations are created with a Polyarylethysulfone (PAES) membrane and can be used to perform all CRRT therapies (SCUF, CVVH, CVVHD and CVVHDF). The HF1000 and HF1400 PAES membranes are designed for ultrafiltration of solutes with minimal protein absorption.

PRISMAFLEX SYSTEM M60/M100/M150 SETS

Indications

The PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.

All treatments administered via the PRISMAFLEX Set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.

The PRISMAFLEX M100 & M150 Sets should be restricted to patients with a body weight greater than 30 kg (66 lb). The pediatric use of the PRISMAFLEX M60 Set should be restricted to children with a body weight greater than 11 kg (24 lb) with respect to extracorporeal blood volume.

The M150, M100 and M60 hemofilter sets are designed for prescription flexibility on the PRISMAFLEX System. Both set configurations are created with the AN 69 Dialyzer Membrane and can be used to perform all CRRT therapies (SCUF, CVVH, CVVHD and CVVHDF).

MARS (Molecular Adsorbent Recirculating System)

Indications

The MARS is indicated for the treatment of drug overdose and poisoning. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.

Contraindication

The MARS is not indicated as a bridge to liver transplant. Safety and efficacy has not been demonstrated for this indication in controlled, randomized clinical trials. The effectiveness of the MARS device in patients that are sedated could not be established in clinical studies and therefore cannot be predicted in sedated patients.