DIANEAL PD-2 WITH DEXTROSE- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution DIANEAL LOW CALCIUM WITH DEXTROSE- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

DIANEAL Low Calcium with Dextrose by

Drug Labeling and Warnings

DIANEAL Low Calcium with Dextrose by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• HIGHLIGHTS OF PRESCRIBING INFORMATION

  These highlights do not include all the information needed to use DIANEAL peritoneal dialysis solutions safely and effectively. See full prescribing 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. (1)

  DOSAGE AND ADMINISTRATION

  For intraperitoneal administration only. (2)

  DOSAGE FORMS AND STRENGTHS

  DIANEAL solutions are available in multiple combinations of ingredients and in composition, calculated osmolarity, pH, and ionic concentrations. See full prescribing information for detailed descriptions of each formulation. (3)

  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)

  ADVERSE REACTIONS

  To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  See 17 for PATIENT COUNSELING INFORMATION.

  Revised: 11/2019

• Table of Contents

  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 not listed.

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 intravenous or intra-arterial administration..

Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based 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 1.73m2 for 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 and APD system preparation.

Product Selection

To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see Dosage Forms and Strengths (3)].

2.2 Adding Medications

If the resealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added.

To add a medication:

• 1. Put on mask. Clean and/or disinfect hands.
• 2. Prepare medication port site using aseptic technique.
• 3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive.
• 4. Reposition container with container ports up and evacuate medication port by squeezing and tapping it.
• 5. Mix solution and additive thoroughly.

2.3 Directions for Use

Warming

DIANEAL peritoneal dialysis solution can be warmed to 37°C (98.6°F). Only dry heat should be used. For CAPD, it is best to warm solutions within the overwrap using a heating pad. Do not immerse DIANEAL solutions in water for warming. Do not use a microwave oven to warm DIANEAL solutions.

To Open

To open, tear the overwrap down at the slit and remove the solution container. Do not use sharp objects to remove the overwrap.

Product Inspection

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. The opacity should diminish gradually.

Inspect the bag connector to ensure the tip protector (pull ring or blue pull tip) is attached. Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL solution for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken. Do not use DIANEAL solution if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

For DIANEAL solutions in ULTRABAG containers, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units.

CAPD therapy using ULTRABAG containers

Select appropriate formulation from Table 1.

Put on mask. Clean and/or disinfect hands. Using aseptic technique;

• 1. Uncoil tubing and drain bag, ensuring that the transfer set is closed.
• 2. Break the connector (Y-set) frangible.
• 3. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed.
• 4. Immediately attach the solution container to patient connector (transfer set).
• 5. Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen.
• 6. Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set.
• 7. Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete.
• 8. Open transfer set to fill. When fill complete, close transfer set.
• 9. Disconnect ULTRABAG container from transfer set and apply MINICAP disconnect cap.
• 10. Upon completion of therapy, discard any unused portion.

APD therapy using AMBU-FLEX containers with pull rings or plastic containers with blue pull tips or pull rings

Select appropriate formulation from Table 1, 2 or 3.

Put on mask. Clean and/or disinfect hands. Using aseptic technique;

• 1. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed.
• 2. Immediately attach the solution container to an appropriate automated peritoneal dialysis set.
• 3. Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis.
• 4. Upon completion of therapy, discard any unused portion.

3 DOSAGE FORMS AND STRENGTHS

DIANEAL peritoneal dialysis solution is formulated with the following ionic concentrations:

Table 1 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX Container with pull ring for APD therapy

			Ionic Concentration (mEq/L)
	OSMOLARITY (mOsmol/L) (calc)	pH	Sodium	Calcium	Magnesium	Chloride	Lactate
DIANEAL PD-2; 1.5% Dextrose	346	5.2; (4.0 to 6.5)	132	3.5	0.5	96	40
DIANEAL PD-2; 2.5% Dextrose	396	5.2; (4.0 to 6.5)	132	3.5	0.5	96	40
DIANEAL PD-2; 4.25% Dextrose	485	5.2; (4.0 to 6.5)	132	3.5	0.5	96	40
DIANEAL Low Calcium; (2.5 mEq/L); 1.5% Dextrose	344	5.2; (4.0 to 6.5)	132	2.5	0.5	95	40
DIANEAL Low Calcium; (2.5 mEq/L); 2.5% Dextrose	395	5.2; (4.0 to 6.5)	132	2.5	0.5	95	40
DIANEAL Low Calcium; (2.5 mEq/L); 4.25% Dextrose	483	5.2; (4.0 to 6.5)	132	2.5	0.5	95	40

Table 2 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy

			Ionic Concentration (mEq/L)
	OSMOLARITY (mOsmol/L) (calc)	pH	Sodium	Calcium	Magnesium	Chloride	Lactate
DIANEAL Low Calcium; (2.5 mEq/L); 1.5% Dextrose	344	5.0 to 6.5	132	2.5	0.5	95	40
DIANEAL Low Calcium; (2.5 mEq/L); 2.5% Dextrose	395	5.0 to 6.5	132	2.5	0.5	95	40
DIANEAL Low Calcium; (2.5 mEq/L); 4.25% Dextrose	483	5.0 to 6.5	132	2.5	0.5	95	40

Table 3 – DIANEAL PD-2 and DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with pull ring for APD therapy

	OSMOLARITY (mOsmol/L) (calc)	pH	Ionic Concentration (mEq/L)
			Sodium	Calcium	Magnesium	Chloride	Lactate
DIANEAL PD-2 1.5% Dextrose	346	5.0 to 5.6	132	3.5	0.5	96	40
DIANEAL PD-2 2.5% Dextrose	396	5.0 to 5.6	132	3.5	0.5	96	40
DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose	344	5.0 to 5.6	132	2.5	0.5	95	40
DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose	395	5.0 to 5.6	132	2.5	0.5	95	40

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

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.

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

5.2 Lactic 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)].

5.3 Overinfusion

Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat overinfusion.

5.4 Electrolyte, Fluid, and Nutrition Imbalances

Peritoneal dialysis may affect a patient’s protein, water-soluble vitamin, potassium, bicarbonate, calcium, and magnesium levels and volume status. Monitor hematology, electrolytes, blood chemistry and fluid status periodically and take appropriate clinical action.

Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, addition of potassium chloride (up to a concentration of 4 mEq/L) to the solution may be necessary to prevent severe hypokalemia. Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion and hypovolemic shock.

5.5 Hyperglycemia

DIANEAL solutions contain dextrose and may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation or modification of antidiabetic therapy during treatment with DIANEAL solutions. Monitor blood glucose.

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)]

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. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneal dialysis.

INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection

METABOLISM AND NUTRITION DISORDERS: Hypovolemia, Hypervolemia, Fluid retention, Hypokalemia, Hyponatremia, Dehydration, Hypochloremia

VASCULAR DISORDERS: Hypotension, Hypertension

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea

GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Peritonitis, Peritoneal cloudy effluent, Vomiting, Diarrhea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort

SKIN AND SUBCUTANEOUS DISORDERS: Stevens-Johnson syndrome, Urticaria, Rash, (including pruritic, erythematous and generalized), Pruritus

MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Myalgia, Muscle spasms, Musculoskeletal pain

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Generalized edema, Pyrexia, Malaise, Infusion site pain, Catheter related complication

7 DRUG INTERACTIONS

As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary.

Diabetic patients may require dosage adjustments of insulin or other treatments for hyperglycemia [see Warnings and Precautions (5.5)].

8 USE IN SPECIFIC POPULATIONS

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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation

The components of DIANEAL solutions are excreted in human milk.

8.4 Pediatric Use

Safety and effectiveness have been established based on published clinical data. No adequate and well-controlled studies have been conducted with DIANEAL solutions in pediatric patients.

8.5 Geriatric Use

Safety and effectiveness have been established based on published clinical data.

10 OVERDOSAGE

There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

11 DESCRIPTION

DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents.

DIANEAL solutions are hyperosmolar solutions.

Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX/Plastic Container with pull ring for APD therapy

	Composition/100 mL
	*Dextrose, Hydrous, USP	Sodium Chloride, USP (NaCl)	Sodium Lactate (C3H5NaO3)	Calcium Chloride, USP (CaCl22H2O)	Magnesium Chloride, USP (MgCl26H2O)
DIANEAL PD-2; 1.5% Dextrose	1.5 g	538 mg	448 mg	25.7 mg	5.08 mg
DIANEAL PD-2; 2.5% Dextrose	2.5 g	538 mg	448 mg	25.7 mg	5.08 mg
DIANEAL PD-2; 4.25% Dextrose	4.25 g	538 mg	448 mg	25.7 mg	5.08 mg
DIANEAL Low Calcium; (2.5 mEq/L); 1.5% Dextrose	1.5 g	538 mg	448 mg	18.3 mg	5.08 mg
DIANEAL Low Calcium; (2.5 mEq/L); 2.5% Dextrose	2.5 g	538 mg	448 mg	18.3 mg	5.08 mg
DIANEAL Low Calcium; (2.5 mEq/L); 4.25% Dextrose	4.25 g	538 mg	448 mg	18.3 mg	5.08 mg

Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy

	Composition/100 mL
	*Dextrose, Hydrous	Sodium Chloride (NaCl)	Sodium Lactate (C3H5NaO3)	Calcium Chloride (CaCl22H2O)	Magnesium Chloride (MgCl26H2O)
DIANEAL Low Calcium; (2.5 mEq/L); 1.5% Dextrose	1.5 g	538 mg	448 mg	18.4 mg	5.08 mg
DIANEAL Low Calcium; (2.5 mEq/L); 2.5% Dextrose	2.5 g	538 mg	448 mg	18.4 mg	5.08 mg
DIANEAL Low Calcium; (2.5 mEq/L); 4.25% Dextrose	4.25 g	538 mg	448 mg	18.4 mg	5.08 mg

The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

DIANEAL peritoneal dialysis solutions are a pharmacologically inactive, hypertonic peritoneal dialysis solution containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DIANEAL solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL solutions contain electrolytes to facilitate the correction of electrolyte abnormalities. DIANEAL solutions contain a buffer, lactate, to help normalize acid-base abnormalities.

12.3 Pharmacokinetics

Absorption

Glucose is rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to the high glucose concentration gradient between DIANEAL solutions compared to blood capillary glucose level. Absorption per unit time will be the highest at the start of an exchange and decreases over time. The rate of glucose absorption will be dependent upon the transport characteristics of the patient’s peritoneal membrane as determined by a peritoneal equilibration test (PET). Glucose absorption will also depend upon the concentration of glucose used for the exchange and the length of the dwell. Transport of other molecules will be dependent upon the molecular size of the solute, the concentration gradient, and the effective peritoneal surface area as determined by the PET.

Metabolism and Elimination

Glucose is metabolized by normal cellular pathways (i.e., glycolysis). Metabolism of lactate occurs in the liver and results in the generation of the bicarbonate. Glucose not absorbed during PD exchange procedure is removed by drainage of the PD solution from the peritoneal cavity.

Drug Interaction Studies

Heparin

No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with DIANEAL solutions.

Antibiotics

No formal clinical drug interaction studies have been performed. In vitro studies of the following medications have demonstrated stability with DIANEAL solutions: amphotericin B, ampicillin, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, sulfamethoxazole/trimethoprim, ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

16 HOW SUPPLIED/STORAGE AND HANDLING

DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 6-7:

Table 6 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapy

Container	Fill Volume (mL)	Container Size (mL)	Product Code	NDC
ULTRABAG; Container	DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
	2000 2500 3000	2000 3000 5000	5B9866 5B9868 5B9857	0941-0426-52 0941-0426-53 0941-0426-55
	DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
	2000 2500 3000	2000 3000 5000	5B9876 5B9878 5B9858	0941-0427-52 0941-0427-53 0941-0427-55
	DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
	2000 2500 3000	2000 3000 5000	5B9896 5B9898 5B9859	0941-0429-52 0941-0429-53 0941-0429-55
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
	1500 2000 2500 3000	2000 2000 3000 5000	5B9765 5B9766 5B9768 5B9757	0941-0424-51 0941-0424-52 0941-0424-53 0941-0424-55
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
	1500 2000 2500 3000	2000 2000 3000 5000	5B9775 5B9776 5B9778 5B9758	0941-0430-51 0941-0430-52 0941-0430-53 0941-0430-55
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
	1500 2000 2500 3000	2000 2000 3000 5000	5B9795 5B9796 5B9798 5B9759	0941-0433-51 0941-0433-52 0941-0433-53 0941-0433-55

Table 7 - DIANEAL Peritoneal Dialysis Solutions for APD therapy

Container	Fill Volume (mL)	Container Size (mL)	Product Code	NDC
AMBU-FLEX / Plastic Container with pull ring	DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
	1000 2000 3000 5000 6000	1000 3000 3000 6000 6000	L5B5163 L5B5166 L5B5169 L5B5193 L5B9710	0941-0411-05 0941-0411-06 0941-0411-04 0941-0411-07 0941-0411-11
	DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
	1000 2000 3000 5000 6000	1000 3000 3000 6000 6000	L5B5173 L5B5177 L5B5179 L5B5194 L5B9711	0941-0413-05 0941-0413-06 0941-0413-04 0941-0413-07 0941-0413-01
	DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
	1000 2000 3000 5000 6000	1000 3000 3000 6000 6000	L5B5183 L5B5187 L5B5189 L5B5195 L5B9712	0941-0415-05 0941-0415-06 0941-0415-04 0941-0415-07 0941-0415-01
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5%Dextrose
	2000 3000 5000 6000	3000 3000 6000 6000	L5B4825 L5B9901 L5B4826 L5B9770	0941-0409-06 0941-0409-05 0941-0409-07 0941-0409-01
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
	2000 3000 5000 6000	3000 3000 6000 6000	L5B9727 L5B9902 L5B5202 L5B9771	0941-0457-08 0941-0457-02 0941-0457-05 0941-0457-01
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
	2000 3000 5000 6000	3000 3000 6000 6000	L5B9747 L5B9903 L5B5203 L5B9772	0941-0459-08 0941-0459-02 0941-0459-05 0941-0459-01
Plastic container with blue pull tip	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
	5000	5000	EZPB5245R	0941-0484-01
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
	5000	5000	EZPB5255R	0941-0487-01
	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
	5000	5000	EZPB5265R	0941-0490-01

All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.

Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.

Store in moisture barrier overwrap and in carton until ready to use.

17 PATIENT COUNSELING INFORMATION

Inspection: Advise patients to inspect DIANEAL peritoneal dialysis solutions before use, and not to use if the solution is cloudy, discolored, contains particulate matter or if there is evidence of leakage.

Administration: Advise patients on proper administration and the importance of using aseptic technique throughout the entire PD procedure. Advise patients only to use dry heat to warm solution to about 37°C (98°F) and not to microwave or submerge in water.

Peritonitis: Advise patients to seek medical attention if they experience signs or symptoms of peritonitis.

SPL UNCLASSIFIED SECTION

Baxter, Ambu-Flex, Dianeal, MiniCap and UltraBag are trademarks of Baxter International Inc.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

0719001298

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC: 0941-0411-06 Container Label

 L5B5166 2000 mL
NDC: 0941-0411-06(APPROX 80 mL EXCESS)

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM
- 0.5 CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER
BAG WHICH MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-615

PD-2 1.5% Dextrose

NDC: 0941-0411-06 Carton Label

L5B516 6-2000 ML
AMBU-FLEX II CONTAINERS1.5%

DIANEAL PD-2 1.5% DEX EXP
PERITONEAL DIALYSIS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410411068

NDC: 0941-0413-06 Container Label

L5B5177 2000 mL
NDC: 0941-0413-06 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

  

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER
BAG WHICH MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-586

PD-2 2.5% Dextrose

NDC: 0941-0413-06 Carton Label

L5B5177 6-2000ML
AMBU-FLEX II CONTAINERS 2.5%

DIANEAL PD-2 2.5% DEX EXP
PERITONEAL DIALYSIS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410413062

NDC: 0941-0415-06 Container Label

L5B5187 2000 mL
NDC: 0941-0415-06 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

  

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

WARNING EXTENSIVE USE OF THIS SOLUTION
DURING ONE PERITONEAL DIALYSIS PROCEDURE CAN
RESULT IN SIGNIFICANT REMOVAL OF WATER FROM
THE PATIENT

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-591

PD-2 4.25% Dextrose 

NDC: 0941-0415-06 Carton Label

L5B5187 6-2000ML
AMBU-FLEX II CONTAINERS 4.25%

DIANEAL PD-2 4.25% DEX EXP
PERITONEAL DIALYSIS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410415066

NDC: 0941-0409-06 Container Label

L5B4825 2000 mL
NDC: 0941-0409-06 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM -
0.5 CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

  

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-640

Low Calcium 1.5% Dextrose

NDC: 0941-0409-06 Carton Label

L5B48256-2000 ML
AMBU-FLEX II CONTAINERS 1.5%

DIANEAL LOW CALCIUM 1.5% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410409065

NDC: 0941-0457-08 Container Label

L5B9727 2000 mL
NDC: 0941-0457-08 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTANER

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

  

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-641

Low Calcium 2.5% Dextrose

NDC: 0941-0457-08 Carton Label

L5B97276-2000ML
AMBU-FLEX II CONTAINERS 2.5%

DIANEAL LOW CALCIUM 2.5% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410457080

NDC: 0941-0459-08 Container Label

L5B9747 2000 mL
NDC: 0941-0459-08 (APPROX 80 mL EXCESS)
3000 mL NOMINAL SIZE CONTANER

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

  

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-642

Low Calcium 4.25% Dextrose

NDC: 0941-0459-08 Carton Label

L5B97476-2000ML
AMBU-FLEX II CONTAINERS 4.25%

DIANEAL LOW CALCIUM 4.25% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 503094104590804

NDC: 0941-0426-52 Container Label

07-25-47-851

5B9866 2000 mL

NDC: 0941-0426-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal PD-2
Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

USE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

PD-2 1.5% Dextrose

 

NDC: 0941-0426-52 Carton Label

5B9866 6-2000ML IN 2000ML

ULTRABAGTM CONTAINERS 1.5%

DIANEAL® PD-2 1.5% DEX EXP

PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410426529

NDC: 0941-0427-52 Container Label

07-25-47-854
5B9876 2000 mL

NDC: 0941-0427-52 (APPROX 80 mL EXCESS)

BaxterLogo
Dianeal PD-2
Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CCONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

PD-2 2.5% Dextrose

NDC: 0941-0427-52 Carton Label

5B9876 6-2000ML IN 2000ML

ULTRABAGTM CONT 2.5%

DIANEAL PD-2 2.5% DEX EXP
PERITONEAL DIALYSIS SOLUTION XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE

XXXXX
(01) 50309410427526

NDC: 0941-0429-52 Container Label

07-25-47-876

5B9896 2000 mL
NDC: 0941-0429-52 (APPROX 80 mL EXCESS)

Baxter Logo
Dianeal PD-2
Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5
CHLORIDE - 96 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

WARNING EXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY A PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION
Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (25°C/77°F) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

NDC: 0491-0429-52 Carton Label

5B9896 6-2000ML IN 2000ML

ULTRABAGTM CONTAINERS 4.25%

DIANEAL® PD-2 4.25% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE

XXXXX
(01) 50309410429520

NDC: 0941-0424-52 Container Label

07-25-47-842

5B9766 2000 mL
NDC: 0941-0424-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSET FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

Low Calcium 1.5% Dextrose

NDC: 0941-0424-52 Carton Label

5B9766 6-2000ML IN 2000ML
ULTRABAGTM CONT 1.5%

DIANEAL® LOW CALCIUM 1.5% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE
XXXXX

(01) 50309410424525

NDC: 0941-0430-52 Container Label

07-25-47-845

5B9776 2000 mL
NDC: 0941-0430-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 2.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSET FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

Low Calcium 2.5% Dextrose

NDC: 0941-0430-52 Carton Label

5B9776 6-2000ML IN 2000ML
ULTRABAGTM CONT 2.5%

DIANEAL® LOW CALCIUM 2.5% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE

XXXXX

(01) 50309410430526

NDC: 0941-0433-52 Container Label

07-25-47-848

5B9796 2000 mL
NDC: 0941-0433-52 (APPROX 80 mL EXCESS)

BaxterLogo

Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSET FOR FULL INFORMATION

WARNING EXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE

AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

Low Calcium 2.5% Dextrose

NDC: 0941-0433-52 Carton Label

5B9796 6-2000ML IN 2000ML
ULTRABAGTM CONT 4.25%

DIANEAL® LOW CALCIUM 4.25% DEX EXP
PERITONEAL DIALYSYS SOLUTION XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT PRIMARY BAR CODE

XXXXX

(01) 503094104330527

NDC: 0941-0484-01 Carton Label

EZPB5245R
NDC: 0941-0484-01

5000 mL
(APPROX 135 mL EXCESS)

BAXTER LOGO

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 1.5% Dextrose

Low Calcium 1.5% Dextrose

EACH 100 mL CONTAINS
448 mg SODIUM LACTATE
pH 5.0 to 6.5

1.5 g DEXTROSE HYDROUS
18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE
5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 344 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

•   CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
  MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO
USE

AVOID EXCESSIVE HEAT SEE INSERT

PL 146 PLASTIC

BAXTER DIANEAL AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN IRELAND

CB-35-03-813

NDC: 0941-0484-01 Carton Label

DIANEAL LOW CALCIUM (2.5 mEq/L)

Peritoneal Dialysis Solution
with 1.5% Dextrose

5000 mL x 2

EZPB5245R

88-46-12-476

LOT XXXXXXXX

EXP MM/YYYY

BAR CODE
(01)00000000000000(17)201200(10)XXXXXXXX

Dianeal Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 1.5% Dextrose

LOT XXXXXXXX

EZPB5245R
5000 mL x 2
EXP MM/YYYY

0941-0487-01 Container Label

EZPB5255R
NDC: 0941-0487-01

5000 mL
(APPROX 135 mL EXCESS)

BAXTER LOGO

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 2.5% Dextrose

Low Calcium 2.5% Dextrose

EACH 100 mL CONTAINS
448 mg SODIUM LACTATE
pH 5.0 to 6.5

2.5 g DEXTROSE HYDROUS
18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE
5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 395 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

•   CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

PL 146 PLASTIC

BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN IRELAND

CB-35-03-814

NDC: 0941-0487-01 Carton Label

DIANEAL LOW CALCIUM (2.5 mEq/L)

Peritoneal Dialysis Solution
with 2.5% Dextrose

5000 mL x 2

EZPB5255R

88-46-12-477

LOT XXXXXXXX

EXP MM/YYYY

BAR CODE
(01)00000000000000(17)201200(10)XXXXXXXX

Dianeal Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 2.5% Dextrose

LOT XXXXXXXX

EZPB5255R
5000 mL x 2
EXP MM/YYYY

NDC: 0941-0490-01 Container Label

EZPB5265R
NDC: 0941-0490-01

5000 mL
(APPROX 135 mL EXCESS)

BAXTER LOGO

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 4.25% Dextrose

Low Calcium 4.25% Dextrose

EACH 100 mL CONTAINS
448 mg SODIUM LACTATE
pH 5.0 to 6.5

4.25 g DEXTROSE HYDROUS
18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE
5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 483 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

•   CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

PL 146 PLASTIC

BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN IRELAND

CB-35-03-815

NDC: 0941-0490-01 Carton Label

DIANEAL LOW CALCIUM (2.5 mEq/L)

Peritoneal Dialysis Solution
with 4.25% Dextrose

5000 mL x 2

EZPB5265R

88-46-12-478

LOT XXXXXXXX

EXP MM/YYYY

BAR CODE
(01)00000000000000(17)201200(10)XXXXXXXX

INGREDIENTS AND APPEARANCE

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0411
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	1.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0411-05	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
2	NDC: 0941-0411-06	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
3	NDC: 0941-0411-07	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
4	NDC: 0941-0411-04	3000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
5	NDC: 0941-0411-11	6000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0413
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0413-05	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
2	NDC: 0941-0413-06	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
3	NDC: 0941-0413-07	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
4	NDC: 0941-0413-01	6000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
5	NDC: 0941-0413-04	3000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0415
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0415-05	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/28/1978
2	NDC: 0941-0415-06	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
3	NDC: 0941-0415-04	3000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
4	NDC: 0941-0415-07	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
5	NDC: 0941-0415-01	6000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0409
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	1.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0409-06	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
2	NDC: 0941-0409-05	3000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
3	NDC: 0941-0409-07	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
4	NDC: 0941-0409-01	6000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0457
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0457-08	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
2	NDC: 0941-0457-02	3000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
3	NDC: 0941-0457-05	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
4	NDC: 0941-0457-01	6000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0459
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0459-08	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
2	NDC: 0941-0459-02	3000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
3	NDC: 0941-0459-05	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978
4	NDC: 0941-0459-01	6000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0426
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	1.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0426-52	2000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
2	NDC: 0941-0426-53	2500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
3	NDC: 0941-0426-55	3000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020163	12/04/1992

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0427
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0427-52	2000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
2	NDC: 0941-0427-53	2500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
3	NDC: 0941-0427-55	3000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020163	12/04/1992

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0429
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0429-52	2000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
2	NDC: 0941-0429-53	2500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
3	NDC: 0941-0429-55	3000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020163	12/04/1992

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0424
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	1.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0424-51	1500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
2	NDC: 0941-0424-52	2000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
3	NDC: 0941-0424-53	2500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
4	NDC: 0941-0424-55	3000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020183	12/04/1992

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0430
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0430-51	1500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
2	NDC: 0941-0430-52	2000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
3	NDC: 0941-0430-53	2500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
4	NDC: 0941-0430-55	3000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020183	12/04/1992

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0433
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0433-51	1500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
2	NDC: 0941-0433-52	2000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
3	NDC: 0941-0433-53	2500 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992
4	NDC: 0941-0433-55	3000 mL in 1 BAG; Type 0: Not a Combination Product	12/04/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020183	12/04/1992

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0484
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	1.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CHLORIDE	18.4 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0484-01	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0487
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.4 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0487-01	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0490
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.4 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0490-01	5000 mL in 1 BAG; Type 0: Not a Combination Product	09/27/1978

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	09/27/1978

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		059140764	ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , MANUFACTURE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , LABEL(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , PACK(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , STERILIZE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , API MANUFACTURE(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		194684502	ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter, S.A. de C.V.		810432484	ANALYSIS(0941-0409, 0941-0457, 0941-0411, 0941-0413) , MANUFACTURE(0941-0409, 0941-0457, 0941-0411, 0941-0413) , LABEL(0941-0409, 0941-0457, 0941-0411, 0941-0413) , PACK(0941-0409, 0941-0457, 0941-0411, 0941-0413) , STERILIZE(0941-0409, 0941-0457, 0941-0411, 0941-0413) , API MANUFACTURE(0941-0409, 0941-0457, 0941-0411, 0941-0413)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare S.A.		988899845	ANALYSIS(0941-0484, 0941-0487, 0941-0490) , MANUFACTURE(0941-0484, 0941-0487, 0941-0490) , LABEL(0941-0484, 0941-0487, 0941-0490) , PACK(0941-0484, 0941-0487, 0941-0490) , STERILIZE(0941-0484, 0941-0487, 0941-0490)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter SA		370353835	ANALYSIS(0941-0484, 0941-0487, 0941-0490)