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Dianeal with Dextrose

Generic Name: sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Dosage Form: injection, solution

Indications and Usage for Dianeal with Dextrose

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

Dianeal with Dextrose Dosage and Administration

Basic Dosing Information

DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous 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 is 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 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)].

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.

Directions for Use

Warming

DIANEAL 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 in water for warming. Do not use a microwave oven to warm DIANEAL.

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, blue pull tip, or blue twist-off tip) is attached. Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL container 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 if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

For DIANEAL in ULTRABAG, 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.

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 from transfer set and apply MINICAP.
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

Select appropriate formulation from Table 1 or 2.

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.

APD therapy using plastic containers with blue twist-off tips

Select appropriate formulation from Table 3.

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

1.
Place and fasten blue outlet port clamp on solution bag administration port, between the blue connector and the solution container.
2.
Remove the blue twist-off tip from connector of solution container. Do not reuse the solution or container once the blue twist-off tip is removed.
3.
Immediately insert the spike of the automated peritoneal dialysis set into the solution bag port.
4.
Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis.
5.
Upon completion of therapy, discard any unused portion.

Dosage Forms and Strengths

DIANEAL 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 Low Calcium Peritoneal Dialysis Solution Plastic container with blue twist-off 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 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

Contraindications

DIANEAL is contraindicated in patients with severe lactic acidosis.

Warnings and Precautions

Peritonitis and Encapsulating Peritoneal Sclerosis

Peritonitis has been associated with DIANEAL 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.

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 in patients with severe lactic acidosis is contraindicated [see Contraindications (4)].

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.

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.

Hyperglycemia

DIANEAL contains 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. Monitor blood glucose.

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)]

Clinical Trials Experience

There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL.

Post-Marketing Experience

The following adverse experiences have been identified during post-approval use of DIANEAL 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

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)].

USE IN SPECIFIC POPULATIONS

Pregnancy

DIANEAL is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL, 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 dialysis solution.

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.

Lactation

The components of DIANEAL are excreted in human milk.

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.

Geriatric Use

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

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.

Dianeal with Dextrose 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 is a hyperosmolar solution.

Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG CONTAINER for CAPD therapy AMBU-FLEX CONTAINER with pull ring for APD therapy
Composition/100 mL
*Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O)

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, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O)

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

Table 6 -DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue twist-off tip for APD therapy

Composition/100 mL
*Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O)

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)
1.5% Dextrose

1.5 g

538 mg

448 mg

18.3 mg

5.08 mg

The plastic container is fabricated from polyvinyl chloride (PL 146 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.

Dianeal with Dextrose - Clinical Pharmacology

Mechanism of Action

DIANEAL is 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 exerts an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL contains electrolytes to facilitate the correction of electrolyte abnormalities. DIANEAL contains a buffer, lactate, to help normalize acid-base abnormalities.

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 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.

Antibiotics

No formal clinical drug interaction studies have been performed. In vitro studies of the following medications have demonstrated stability with DIANEAL: 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.

How Supplied/Storage and Handling

DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:

Table 7 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapy

Container

Fill Volume (mL)

Container Size (mL)

Product Code

NDC

ULTRABAG

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 8 - DIANEAL Peritoneal Dialysis Solutions for APD therapy

Container

Fill Volume (mL)

Container Size (mL)

Product Code

NDC

AMBU-FLEX 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

 

Plastic container with blue twist-off tip

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

6000

6000

VBB4928US

0941-0472-01

 

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

6000

6000

VBB4931US

0941-0475-01

 

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.

Patient Counseling Information

Inspection: Advise patients to inspect DIANEAL 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 370C (980F) and not to microwave or submerge in water.

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

BAXTER, DIANEAL, AMBU-FLEX, ULTRABAG, MINICAP, and PL 146 are trademarks of Baxter International, Inc.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

071975909

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 0941-0472-01 Container Label

LOT
EXP

VBB4928US
NDC 0941-0472-01

6000 mL
(APPROX 225 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
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 5.0 to 5.6

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

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 MEXICO

88-80-32-XXX

NDC 0941-0472-01 Carton Label

DIANEAL LOW CALCIUM 1.5 DEX PERITONEAL DIALYSIS SOLUTION

VIAFLEX

3-6000 mL

1.5%

LOT XXXXX
EXP MMYYYY

VBB4928US

NDC 0941-0475-01 Container Label

LOT
EXP

VBB4931US
NDC 0941-0475-01

6000 mL
(APPROX 225 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
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 5.0 to 5.6

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

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 MEXICO

88-80-32-XXX

NDC 0941-0475-01 Carton Label

DIANEAL LOW CALCIUM 2.5 DEX PERITONEAL DIALYSIS SOLUTION

VIAFLEX

3-6000 mL

2.5%

LOT XXXXX
EXP MMYYYY

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

DIANEAL PD-2 WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0941-0411
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0411-05 1000 mL in 1 BAG
2 NDC:0941-0411-06 2000 mL in 1 BAG
3 NDC:0941-0411-07 5000 mL in 1 BAG
4 NDC:0941-0411-04 3000 mL in 1 BAG
5 NDC:0941-0411-11 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0413
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0413-05 1000 mL in 1 BAG
2 NDC:0941-0413-06 2000 mL in 1 BAG
3 NDC:0941-0413-07 5000 mL in 1 BAG
4 NDC:0941-0413-01 6000 mL in 1 BAG
5 NDC:0941-0413-04 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0415
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 4.25 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0415-05 1000 mL in 1 BAG
2 NDC:0941-0415-06 2000 mL in 1 BAG
3 NDC:0941-0415-04 3000 mL in 1 BAG
4 NDC:0941-0415-07 5000 mL in 1 BAG
5 NDC:0941-0415-01 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0409
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0409-06 2000 mL in 1 BAG
2 NDC:0941-0409-05 3000 mL in 1 BAG
3 NDC:0941-0409-07 5000 mL in 1 BAG
4 NDC:0941-0409-01 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0457
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0457-08 2000 mL in 1 BAG
2 NDC:0941-0457-02 3000 mL in 1 BAG
3 NDC:0941-0457-05 5000 mL in 1 BAG
4 NDC:0941-0457-01 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0459
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 4.25 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0459-08 2000 mL in 1 BAG
2 NDC:0941-0459-02 3000 mL in 1 BAG
3 NDC:0941-0459-05 5000 mL in 1 BAG
4 NDC:0941-0459-01 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0426
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0426-52 2000 mL in 1 BAG
2 NDC:0941-0426-53 2500 mL in 1 BAG
3 NDC:0941-0426-55 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0427
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0427-52 2000 mL in 1 BAG
2 NDC:0941-0427-53 2500 mL in 1 BAG
3 NDC:0941-0427-55 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0429
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 4.25 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0429-52 2000 mL in 1 BAG
2 NDC:0941-0429-53 2500 mL in 1 BAG
3 NDC:0941-0429-55 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0424
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0424-51 1500 mL in 1 BAG
2 NDC:0941-0424-52 2000 mL in 1 BAG
3 NDC:0941-0424-53 2500 mL in 1 BAG
4 NDC:0941-0424-55 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0430
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0430-51 1500 mL in 1 BAG
2 NDC:0941-0430-52 2000 mL in 1 BAG
3 NDC:0941-0430-53 2500 mL in 1 BAG
4 NDC:0941-0430-55 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0433
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 4.25 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0433-51 1500 mL in 1 BAG
2 NDC:0941-0433-52 2000 mL in 1 BAG
3 NDC:0941-0433-53 2500 mL in 1 BAG
4 NDC:0941-0433-55 3000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0472
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0472-01 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0475
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0475-01 6000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0484
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 18.4 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0484-01 5000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0487
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.4 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0487-01 5000 mL in 1 BAG
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 LABEL Item Code (Source) NDC:0941-0490
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 4.25 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.4 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0941-0490-01 5000 mL in 1 BAG
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 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, 0941-0472, 0941-0475, 0941-0484, 0941-0487, 0941-0490), 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, 0941-0472, 0941-0475, 0941-0484, 0941-0487, 0941-0490), 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, 0941-0472, 0941-0475, 0941-0484, 0941-0487, 0941-0490), 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, 0941-0472, 0941-0475, 0941-0484, 0941-0487, 0941-0490), 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, 0941-0472, 0941-0475, 0941-0484, 0941-0487, 0941-0490)
Establishment
Name Address ID/FEI 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 Operations
Baxter, S.A. de C.V. 810432484 ANALYSIS(0941-0472, 0941-0475), MANUFACTURE(0941-0472, 0941-0475), LABEL(0941-0472, 0941-0475), PACK(0941-0472, 0941-0475), STERILIZE(0941-0472, 0941-0475)
Establishment
Name Address ID/FEI 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)
Revised: 08/2016
 
Baxter Healthcare Corporation
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