20231220_aa268d3f-7389-4f25-801f-5d4825495f08 (2)

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
Baxter Healthcare Corporation
----------
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
DIANEAL LOW CALCIUM (dextrose) peritoneal dialysis solution
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
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.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE

DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal
failure.
2 DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information

DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only.
Not for 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) pH Sodium Calcium Magnesium Chloride Lactate
(calc)
DIANEAL 346 5.2 132 3.5 0.5 96 40
PD-2 (4.0 to
1.5% 6.5)
Dextrose
DIANEAL 396 5.2 132 3.5 0.5 96 40
PD-2 (4.0 to
2.5% 6.5)
Dextrose
DIANEAL 485 5.2 132 3.5 0.5 96 40
PD-2 (4.0 to
4.25% 6.5)
Dextrose
DIANEAL 344 5.2 132 2.5 0.5 95 40
Low (4.0 to
Calcium 6.5)
(2.5
mEq/L)
1.5%
Dextrose
DIANEAL 395 5.2 132 2.5 0.5 95 40
Low (4.0 to
Calcium 6.5)
(2.5
mEq/L)
2.5%
Dextrose
DIANEAL 483 5.2 132 2.5 0.5 95 40
Low (4.0 to
Calcium 6.5)
(2.5
mEq/L)
4.25%
Dextrose
Table 2 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container

with blue pull tip for APD therapy
Ionic Concentration
(mEq/L)
OSMOLARITY
(mOsmol/L) pH Sodium Calcium Magnesium Chloride Lactate
(calc)
DIANEAL 344 5.0 to 132 2.5 0.5 95 40
Low 6.5
Calcium
(2.5
mEq/L)
1.5%
Dextrose
DIANEAL 395 5.0 to 132 2.5 0.5 95 40
Low 6.5
Calcium
(2.5
mEq/L)
2.5%
Dextrose
DIANEAL 483 5.0 to 132 2.5 0.5 95 40
Low 6.5
Calcium
(2.5
mEq/L)
4.25%
Dextrose
Table 3 – DIANEAL PD-2 and DIANEAL Low Calcium Peritoneal Dialysis

Solution Plastic container with pull ring for APD therapy
OSMOLARITY Ionic Concentration

(mOsmol/L) pH (mEq/L)
(calc) Sodium Calcium Magnesium Chloride Lactate
DIANEAL 346 5.0 132 3.5 0.5 96 40
PD-2 to
1.5% 5.6
Dextrose
DIANEAL 396 5.0 132 3.5 0.5 96 40
PD-2 to
2.5% 5.6
Dextrose
DIANEAL 344 5.0 132 2.5 0.5 95 40
Low to
Calcium 5.6
(2.5
mEq/L)
1.5%
Dextrose
DIANEAL 395 5.0 132 2.5 0.5 95 40
Low to
Calcium 5.6
(2.5
mEq/L)
2.5%
Dextrose
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
Sodium
*Dextrose, Sodium Calcium Magnesium
Chloride,
Hydrous, Lactate Chloride, USP Chloride, USP
USP
USP
USP (C3H5NaO3) (CaCl2•2H2O) (MgCl2•6H2O)
(NaCl)
DIANEAL
PD-2
1.5 g 538 mg 448 mg 25.7 mg 5.08 mg
1.5%
Dextrose
DIANEAL
PD-2
2.5 g 538 mg 448 mg 25.7 mg 5.08 mg
2.5%
Dextrose
DIANEAL
PD-2
4.25 g 538 mg 448 mg 25.7 mg 5.08 mg
4.25%
Dextrose
DIANEAL
Low
Calcium
(2.5 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg
mEq/L)
1.5%
Dextrose
DIANEAL
Low
Calcium
(2.5 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg
mEq/L)
2.5%
Dextrose
DIANEAL
Low
Calcium
(2.5 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg
mEq/L)
4.25%
Dextrose
Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic

container with blue pull tip for APD therapy
Composition/100 mL
Sodium Sodium Calcium Magnesium
*Dextrose,
Chloride Lactate Chloride Chloride
Hydrous
(NaCl) (C3H5NaO3) (CaCl2•2H2O) (MgCl2•6H2O)
DIANEAL
Low
Calcium
(2.5 1.5 g 538 mg 448 mg 18.4 mg 5.08 mg
mEq/L)
1.5%
Dextrose
DIANEAL
Low
Calcium
(2.5 2.5 g 538 mg 448 mg 18.4 mg 5.08 mg
mEq/L)
2.5%
Dextrose
DIANEAL
Low
Calcium
(2.5 4.25 g 538 mg 448 mg 18.4 mg 5.08 mg
mEq/L)
4.25%
Dextrose
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
Fill Volume Container Size
Container Product Code NDC
(mL) (mL)
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
2000 2000 5B9866 0941-0426-52
2500 3000 5B9868 0941-0426-53
3000 5000 5B9857 0941-0426-55
2000 2000 5B9876 0941-0427-52
2500 3000 5B9878 0941-0427-53
3000 5000 5B9858 0941-0427-55
2000 2000 5B9896 0941-0429-52
2500 3000 5B9898 0941-0429-53
3000 5000 5B9859 0941-0429-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 1.5% Dextrose
ULTRABAG 1500 2000 5B9765 0941-0424-51
Container 2000 2000 5B9766 0941-0424-52
2500 3000 5B9768 0941-0424-53
3000 5000 5B9757 0941-0424-55
with 2.5% Dextrose
1500 2000 5B9775 0941-0430-51
2000 2000 5B9776 0941-0430-52
2500 3000 5B9778 0941-0430-53
3000 5000 5B9758 0941-0430-55
with 4.25% Dextrose
1500 2000 5B9795 0941-0433-51
2000 2000 5B9796 0941-0433-52
2500 3000 5B9798 0941-0433-53
3000 5000 5B9759 0941-0433-55
Table 7 - DIANEAL Peritoneal Dialysis Solutions for APD therapy

Container Fill Volume Container Size Product Code NDC
(mL) (mL)
1000 1000 L5B5163 0941-0411-05
2000 3000 L5B5166 0941-0411-06
3000 3000 L5B5169 0941-0411-04
5000 6000 L5B5193 0941-0411-07
6000 6000 L5B9710 0941-0411-11
1000 1000 L5B5173 0941-0413-05
2000 3000 L5B5177 0941-0413-06
3000 3000 L5B5179 0941-0413-04
5000 6000 L5B5194 0941-0413-07
6000 6000 L5B9711 0941-0413-01
DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25%
Dextrose
1000 1000 L5B5183 0941-0415-05
2000 3000 L5B5187 0941-0415-06
3000 3000 L5B5189 0941-0415-04
AMBU-FLEX /
5000 6000 L5B5195 0941-0415-07
Plastic
6000 6000 L5B9712 0941-0415-01
Container with
pull ring
with 1.5%Dextrose
2000 3000 L5B4825 0941-0409-06
3000 3000 L5B9901 0941-0409-05
5000 6000 L5B4826 0941-0409-07
6000 6000 L5B9770 0941-0409-01
with 2.5% Dextrose
2000 3000 L5B9727 0941-0457-08
3000 3000 L5B9902 0941-0457-02
5000 6000 L5B5202 0941-0457-05
6000 6000 L5B9771 0941-0457-01
with 4.25% Dextrose
2000 3000 L5B9747 0941-0459-08
3000 3000 L5B9903 0941-0459-02
5000 6000 L5B5203 0941-0459-05
6000 6000 L5B9772 0941-0459-01
with 1.5% Dextrose
5000 5000 EZPB5245R 0941-0484-01
Plastic DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
container with with 2.5% Dextrose
blue pull tip 5000 5000 EZPB5255R 0941-0487-01
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.
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 0941-0411-11 (07-25-00-0740) Container Label
L5B9710 6000 mL
NDC 0941-0411-11(APPROX 225 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
PD-2 1.5% Dextrose
Bar Code
(01)00309410411117
L5B5194 5000 mL
NDC 0941-0413-07 (APPROX 150 mL EXCESS)
BaxterLogo
Dianeal PD-2
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
CAUTIONS SQUEEZE AND INSPECT INNER
BAG WHICH MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND
Rx ONLY
USE
MADE IN USA
PD-2 2.5% Dextrose
Bar Code
(01) 00309410413074
L5B5187 2000 mL
3000 mL NOMINAL SIZE CONTAINER
BaxterLogo
Dianeal PD-2
with 4.25% Dextrose
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
Rx ONLY
USE
MADE IN USA
PD-2 4.25% Dextrose
L5B4826 5000 mL
BaxterLogo
Dianeal
Low Calcium (2.5 mEq/L)
with 1.5% Dextrose
EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS
USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM
mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM -
0.5 CHLORIDE - 95 LACTATE - 40
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND
Rx ONLY
STORE UNIT IN MOISTURE BARRIER OVERWRAP
AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
TO USE AVOID EXCESSIVE HEAT SEE INSERT
MADE IN USA
Low Calcium 1.5% Dextrose
Bar Code
(01)00309410409077
L5B9727 2000 mL
3000 mL NOMINAL SIZE CONTANER
BaxterLogo
Dianeal
with 2.5% Dextrose
LEAKS ARE FOUND
Rx ONLY
USE
MADE IN USA
Bar Code
(01)00309410457085
NDC 0941-0459-08 Container Label
L5B9747 2000 mL
3000 mL NOMINAL SIZE CONTANER
BaxterLogo
Dianeal
with 4.25% Dextrose
LEAKS ARE FOUND
Rx ONLY
USE
MADE IN USA 07-25-56-642
07-25-47-851
5B9866 2000 mL
BaxterLogo
Dianeal PD-2
with 1.5% Dextrose
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
READ PACKAGE INSERT FOR FULL INFORMATION
IF LEAKS ARE FOUND
Rx ONLY
USE
UltraBag CONTAINER PL 146 PLASTIC
BAXTER DIANEAL ULTRABAG AND PL 146 ARE
MADE IN USA
US PAT NOS 4340049 4346703
4439188 4573980
PD-2 1.5% Dextrose
07-25-47-854
5B9876 2000 mL
BaxterLogo
Dianeal PD-2
with 2.5% Dextrose
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
DOSAGE AS DIRECTED BY PHYSICIAN
IF LEAKS ARE FOUND
Rx ONLY
USE
UltraBag CCONTAINER PL 146 PLASTIC
MADE IN USA
US PAT NOS 4340049 4346703
4439188 4573980
PD-2 2.5% Dextrose
07-25-47-876
5B9896 2000 mL
Baxter Logo
Dianeal PD-2
with 4.25% Dextrose
WARNING EXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
DOSAGE AS DIRECTED BY A PHYSICIAN
CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND
Rx ONLY
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (25°C/77°F) UNTIL READY TO USE
MADE IN USA
US PAT NOS 4340049 4346703
4439188 4573980
PD-2 4.25% Dextrose
07-25-47-842
5B9766 2000 mL
BaxterLogo
Dianeal
Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution
with 1.5% Dextrose
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)
READ PACKAGE INSET FOR FULL INFORMATION
IF LEAKS ARE FOUND
Rx ONLY
USE
MADE IN USA
US PAT NOS 4340049 4346703
4439188 4573980
5B9776 2000 mL
BaxterLogo
Dianeal
with 2.5% Dextrose
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)
IF LEAKS ARE FOUND
Rx ONLY
USE
MADE IN USA
US PAT NOS 4340049 4346703
4439188 4573980
07-25-47-848
5B9796 2000 mL
BaxterLogo
Dianeal
with 4.25% Dextrose
WARNING EXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND
Rx ONLY
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F)
UNTIL READY TO USE
BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER
INTERNATIONAL INC
MADE IN USA
US PAT NOS 4340049 4346703
4439188 4573980
EZPB5245R
NDC 0941-0484-01
5000 mL
(APPROX 135 mL EXCESS)
BAXTER LOGO
Dianeal
with 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)
POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A
PHYSICIAN

MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND

Rx ONLY
USE
PL 146 PLASTIC
BAXTER DIANEAL AND PL 146 ARE
MADE IN IRELAND
CB-35-03-813
0941-0487-01 Container Label
EZPB5255R
NDC 0941-0487-01
5000 mL
BAXTER LOGO
Dianeal
with 2.5% Dextrose
pH 5.0 to 6.5
PHYSICIAN
CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

STERILITY DISCARD IF LEAKS ARE FOUND

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
EZPB5265R
NDC 0941-0490-01
5000 mL
BAXTER LOGO
Dianeal
with 4.25% Dextrose
pH 5.0 to 6.5
PHYSICIAN
CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

STERILITY DISCARD IF LEAKS ARE FOUND

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
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

Basis of
Ingredient Name Strength
Basis of
Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - DEXTROSE 1.5 g
UNII:5SL0G7R0OK) MONOHYDRATE in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, SODIUM 538 mg
CHLORIDE ION - UNII:Q32Z N48698) CHLORIDE in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, 448 mg
SODIUM LACTATE
LACTIC ACID - UNII:33X04XA5AT) in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6Z B, CALCIUM 25.7 mg
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - MAGNESIUM 5.08 mg
UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32Z N48698) CHLORIDE in 100 mL
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Packaging
Marketing Start Marketing End
# Item Code Package Description
Date Date
NDC:0941-0411- 1000 mL in 1 BAG; Type 0: Not a Combination
1 09/27/1978
05 Product
2 09/27/1978
06 Product
3 09/27/1978
07 Product
4 09/27/1978
04 Product
5 09/27/1978
11 Product
Marketing Information
Marketing Application Number or Monograph Marketing Start Marketing End
Category Citation Date Date
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/27/1978
05 Product
2 09/27/1978
06 Product
3 09/27/1978
07 Product
4 09/27/1978
01 Product
5 09/27/1978
04 Product
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/28/1978
05 Product
2 09/27/1978
06 Product
3 09/27/1978
04 Product
4 09/27/1978
07 Product
5 09/27/1978
01 Product
NDA NDA017512 09/27/1978
DIANEAL LOW CALCIUM WITH DEXTROSE

solution
Product Information

Basis of
Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/27/1978
06 Product
2 09/27/1978
05 Product
3 09/27/1978
07 Product
4 09/27/1978
01 Product
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/27/1978
08 Product
2 09/27/1978
02 Product
3 09/27/1978
05 Product
4 09/27/1978
01 Product
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/27/1978
08 Product
2 09/27/1978
02 Product
3 09/27/1978
05 Product
4 09/27/1978
01 Product
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Strength
SODIUM LACTATE
SODIUM LACTATE
Packaging
Date Date
1 12/04/1992
52 Product
2 12/04/1992
53 Product
3 12/04/1992 05/27/2025
55 Product
NDA NDA020163 12/04/1992

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 12/04/1992
52 Product
2 12/04/1992
53 Product
3 12/04/1992 05/08/2025
55 Product
NDA NDA020163 12/04/1992

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 12/04/1992
52 Product
2 12/04/1992
53 Product
3 12/04/1992 05/08/2025
55 Product
NDA NDA020163 12/04/1992

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 12/04/1992
51 Product
2 12/04/1992
52 Product
3 12/04/1992
53 Product
4 12/04/1992 05/27/2025
55 Product
NDA NDA020183 12/04/1992

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 12/04/1992
51 Product
2 12/04/1992
52 Product
3 12/04/1992
53 Product
4 12/04/1992 05/28/2025
55 Product
NDA NDA020183 12/04/1992

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 12/04/1992
51 Product
2 12/04/1992
52 Product
3 12/04/1992
53 Product
4 12/04/1992 05/08/2025
55 Product
NDA NDA020183 12/04/1992

solution
Product Information

Basis of
Strength
SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM 448 mg
SODIUM LACTATE
CATION - UNII:LYR4M0NH37) in 100 mL
CALCIUM 18.4 mg
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6Z B)
CHLORIDE in 100 mL
Packaging
Date Date
1 09/27/1978
01 Product
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/27/1978
01 Product
NDA NDA017512 09/27/1978

solution
Product Information

Basis of
Strength
SODIUM LACTATE
Packaging
Date Date
1 09/27/1978
01 Product
NDA NDA017512 09/27/1978
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Business Operations
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,
Baxter
0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) ,
Healthcare 059140764
PACK(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-
Corporation
0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433) , STERILIZ E(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
Baxter
ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-
Healthcare 194684502
0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)
Corporation
Establishment
ANALYSIS(0941-0409, 0941-0457, 0941-0411, 0941-0413) , MANUFACTURE(0941-0409,
Baxter, 0941-0457, 0941-0411, 0941-0413) , LABEL(0941-0409, 0941-0457, 0941-0411, 0941-
S.A. de 810432484 0413) , PACK(0941-0409, 0941-0457, 0941-0411, 0941-0413) , STERILIZ E(0941-0409,
C.V. 0941-0457, 0941-0411, 0941-0413) , API MANUFACTURE(0941-0409, 0941-0457, 0941-
0411, 0941-0413)
Establishment
Baxter ANALYSIS(0941-0484, 0941-0487, 0941-0490) , MANUFACTURE(0941-0484, 0941-
Healthcare 988899845 0487, 0941-0490) , LABEL(0941-0484, 0941-0487, 0941-0490) , PACK(0941-0484,
S.A. 0941-0487, 0941-0490) , STERILIZ E(0941-0484, 0941-0487, 0941-0490)
Establishment
Baxter ANALYSIS(0941-0411, 0941-0413, 0941-0415, 0941-0409, 0941-0457, 0941-0459, 0941-
370353835
SA 0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433)
Establishment
Baxter ANALYSIS(0941-0424, 0941-0430) , MANUFACTURE(0941-0424, 0941-0430) ,
Healthcare 189326168 LABEL(0941-0424, 0941-0430) , PACK(0941-0424, 0941-0430) , STERILIZ E(0941-
Corporation 0424, 0941-0430)
Revised: 11/2019 Baxter Healthcare Corporation

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DIANEAL PD-2 WITH DEXTROSE- sodium chloride, sodium lactate, calcium

chloride, magnesium chloride and dextrose injection, solution

HIGHLIGHTS OF PRESCRIBING INFORMATION

DIANEAL (dextrose) peritoneal dialysis solution

• Pre-existing severe lactic acidosis (4)

WARNINGS AND PRECAUTIONS

• Encapsulating peritoneal sclerosis (5.1)

FULL PRESCRIBING INFORMATION: CONTENTS*

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Basic Dosing Information

2.2 Adding Medications

1. Put on mask. Clean and/or disinfect hands.

2.3 Directions for Use

3 DOSAGE FORMS AND STRENGTHS

Table 1 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution

Table 2 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container

Table 3 – DIANEAL PD-2 and DIANEAL Low Calcium Peritoneal Dialysis

OSMOLARITY Ionic Concentration

5 WARNINGS AND PRECAUTIONS

5.1 Peritonitis and Encapsulating Peritoneal Sclerosis

5.2 Lactic Acidosis

5.4 Electrolyte, Fluid, and Nutrition Imbalances

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

8.4 Pediatric Use

8.5 Geriatric Use

Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution

Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic

12.1 Mechanism of Action

16 HOW SUPPLIED/STORAGE AND HANDLING

Table 7 - DIANEAL Peritoneal Dialysis Solutions for APD therapy

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0941-0484-01 Container Label

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH

DO NOT USE UNLESS SOLUTION IS CLEAR

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

DO NOT USE UNLESS SOLUTION IS CLEAR

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

DO NOT USE UNLESS SOLUTION IS CLEAR

DIANEAL PD-2 WITH DEXTROSE

Route of Administration INTRAPERITONEAL

Active Ingredient/Active Moiety

DIANEAL PD-2 WITH DEXTROSE

Route of Administration INTRAPERITONEAL

Active Ingredient/Active Moiety

DIANEAL PD-2 WITH DEXTROSE

Route of Administration INTRAPERITONEAL

Active Ingredient/Active Moiety

DIANEAL LOW CALCIUM WITH DEXTROSE

Route of Administration INTRAPERITONEAL

Active Ingredient/Active Moiety

DIANEAL LOW CALCIUM WITH DEXTROSE

Route of Administration INTRAPERITONEAL

Active Ingredient/Active Moiety

DIANEAL LOW CALCIUM WITH DEXTROSE

Route of Administration INTRAPERITONEAL

Active Ingredient/Active Moiety

DIANEAL PD-2 WITH DEXTROSE