Delflex W/ Dextrose 1.5% in Plastic Container

1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis. For treatment of chronic kidney failure. ( 1 )

4. CONTRAINDICATIONS None. None

5. WARNINGS AND PRECAUTIONS Monitor patient for electrolyte, fluid, and nutrition imbalances. ( 5.1 ) Encapsulating Peritonitis Sclerosis (EPS) ( 5.2 ) Peritonitis: Initiate appropriate antimicrobial therapy ( 5.2 ) Monitor for Lactic Acidosis in patients at risk. ( 5.3 )

5.1Electrolyte, Fluid and Nutrition Imbalances

Peritoneal dialysis may affect a patient's protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically and take appropriate clinical action. Potassium is omitted from DELFLEX solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.

To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange. Significant loss of protein, amino acids and water-soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

5.2Peritonitis and Encapsulating Peritoneal Sclerosis Infectious

and aseptic peritonitis has been associated with peritoneal dialysis therapy. Following DELFLEX use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy.