Dianeal PD-2 W/ Dextrose 1.5% in Plastic Container

DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. For management of acute or chronic renal failure.

DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis.

• Pre-existing severe lactic acidosis ( 4 )

• Encapsulating peritoneal sclerosis ( 5.1 )
• Peritonitis: Initiate appropriate antimicrobial therapy ( 5.1 )
• Monitor for lactic acidosis in patients at risk ( 5.2 )
• Monitor for electrolyte, fluid, and nutrition imbalances ( 5.4 )

5.1Peritonitis and Encapsulating Peritoneal Sclerosis

Peritonitis has been associated with DIANEAL peritoneal dialysis solution use. Following 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. Encapsulating Peritoneal Sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and has been reported in patients using DIANEAL solutions.

5.2Lactic Acidosis

Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute renal failure, hepatic failure, inborn errors of metabolism, and treatment with drugs such as nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions. Use of DIANEAL solutions in patients with severe lactic acidosis is contraindicated [see Contraindications (4) ].