HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useDIANEAL peritoneal dialysis solutions safely and effectively. See fullprescribing information for DIANEAL solutions
DIANEAL(dextrose) peritoneal dialysis solution
Initial U.S. Approval: 1981
DIANEAL PD-2 (dextrose) peritoneal dialysis solution
Initial U.S. Approval: 1992
DIANEAL LOW CALCIUM (dextrose) peritoneal dialysis solution
Initial U.S. Approval: 1992
INDICATIONS AND USAGE
For management of acute or chronic renal failure.
DOSAGE AND ADMINISTRATION
For intraperitoneal administration only. (2)
DOSAGE FORMS AND STRENGTHS
DIANEAL solutions are available in multiple combinations of ingredients andin composition, calculated osmolarity, pH, and ionic concentrations. See fullprescribing information for detailed descriptions of each formulation.
CONTRAINDICATIONS
Pre-existing severe lactic acidosis (4)
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)
To report SUSPECTED ADVERSE REACTIONS, contact BaxterHealthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised: [03/2018]
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
2.2 Adding Medications
2.3 Directions for Use
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Peritonitis and Encapsulating Peritoneal Sclerosis
5.2 Lactic Acidosis
5.3 Overinfusion
5.4 Electrolyte, Fluid, and Nutrition Imbalances
5.5 Hyperglycemia
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are notlisted

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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.
2 DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenousadministration.
Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysisbased on the patient’s clinical condition, fluid, electrolyte and specific needs.The fill volume depends on body size,usually from 2.0 to 2.5 liters per 1.73m2for adults.
DIANEAL peritoneal dialysis solutions are intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD)or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD andAPD system pr