Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose

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

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label: Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1) ] Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4) ] To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL peritoneal dialysis solutions. 6.2 Post-Marketing Experience The following adverse experiences have been identified during post-approval use of DIANEAL solutions or in conjunction with performing the peritoneal dialysis procedure.

8.1 Pregnancy DIANEAL peritoneal dialysis solution is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriate monitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DIANEAL solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.

5 WARNINGS AND PRECAUTIONS • 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 ) 5.1 Peritonitis 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. 4 CONTRAINDICATIONS DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis. • Pre-existing severe lactic acidosis ( 4 )