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Name:Dianeal Pd-2 Peritoneal Dialysis Solution With Dextrose
Manufacturer:Baxter Healthcare Corporation
Category:Prescription Marketed Drugs


DIANEAL PD-2 Peritoneal Dialysis SolutionAMBU-FLEX Container For Peritoneal DialysisFor intraperitoneal administration only

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE - dextrose, sodium chloride, sodium lactate, calcium chloride and magnesium chloride injection, solution 
Baxter Healthcare Corporation

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DIANEAL PD-2 Peritoneal Dialysis Solution
AMBU-FLEX Container For Peritoneal Dialysis
For intraperitoneal administration only

DESCRIPTION

DIANEAL PD-2 peritoneal dialysis solutions in AMBU-FLEX containers are sterile, nonpyrogenic solutions for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.

Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 1.

Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Frequent monitoring of serum electrolytes is indicated.

Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated (Nolph et al. 1981), the magnesium concentration of this formulation has been reduced to 0.5 mEq/L. Average plasma magnesium levels have not been reported for chronic IPD and CCPD patients. Serum magnesium levels should be monitored and if low, oral magnesium supplements, oral magnesium containing phosphate binders, or peritoneal dialysis solutions containing higher magnesium concentrations may be used.

Because average serum bicarbonate levels in some chronic CAPD patients (Nolph et al. 1981), some chronic IPD patients (La Greca et al. 1980), and some chronic CCPD patients (Diaz-Buxo et al. 1983) have been observed to be somewhat lower than normal values, the bicarbonate precursor (lactate) concentration of this formulation has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.

The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity by freezing point depression determination of DIANEAL PD-2 peritoneal dialysis solution with 1.5% dextrose is approximately 334 mOsmol/L, compared with measured values in normal human serum of 280 mOsmol/L.

The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the 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 tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance.

The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the peritoneal cavity. With the exception of lactate, present as a bicarbonate precursor, electrolyte concentrations in the fluid have been formulated to attempt to normalize plasma electrolyte concentrations resulting from osmosis and diffusion across the peritoneal membrane (between the plasma of the patient and the dialysis fluid). Toxic substances and metabolites, present in high concentrations in the blood, cross the peritoneal membrane into the dialyzing fluid. Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma, creating an osmotic gradient which facilitates fluid removal from the patient’s plasma into the peritoneal cavity. After a period of time (dwell time), the fluid is drained from the cavity.

INDICATIONS AND USAGE

Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate (Vaamonde and Perez 1977). It may also be indicated in the treatment of certain fluid and electrolyte disturbances, and for patients intoxicated with certain poisons and drugs (Knepshield et al. 1977). However, for many substances other methods of detoxification have been reported to be more effective than peritoneal dialysis (Vaamonde and Perez 1977; Chang 1977).

CONTRAINDICATIONS

None known

WARNINGS

Peritoneal dialysis should be done with great care, if at all, in patients with a number of abdominal conditions including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, and large polycystic kidneys (Vaamonde and Perez 1977). Other conditions include recent aortic graft replacement and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.

An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure, volume depletion, and shock.

Excessive use of DIANEAL PD-2 peritoneal dialysis solution with 3.5% or 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

In acute renal failure patients, plasma electrolyte concentrations should be monitored periodically during the procedure. Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.

Because average plasma magnesium levels in chronic CAPD patients have been observed to be elevated (Nolph et al. 1981), the magnesium concentration of this formulation has been reduced to 0.5 mEq/L. Average plasma magnesium levels have not been reported for chronic IPD and CCPD patients. Serum magnesium levels should be monitored and if low, oral magnesium supplements, oral magnesium containing phosphate binders, or peritoneal dialysis solutions containing higher magnesium concentrations may be used.

Because average serum bicarbonate levels in some chronic CAPD patients (Nolph et al. 1981), some chronic IPD patients (La Greca et al. 1980), and some chronic CCPD patients (Diaz-Buxo et al. 1983), have been observed to be somewhat lower than normal values, the bicarbonate precursor (lactate) concentration of this formulation has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.

Not for use in the treatment of lactic acidosis.

Potassium is omitted from DIANEAL PD-2 solutions because dialysis may be performed to correct hyperkalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician.

The use of 5 or 6 liters of dialysis solution is not indicated in a single exchange.

Refer to manufacturer’s directions accompanying drugs to obtain full information on additives.

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

After the pull ring has been removed, inspect connector of solution container for fluid flow. A few drops of solution within the connector or pull ring may be present due to condensation of water resulting from the sterilization process. If a continuous stream of fluid is noted, discard solution because sterility may be impaired.

After removing overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard the solution because the sterility may be impaired.

Freezing of solution may occur at temperatures below 0°C (32°F). Do not flex or manipulate container when frozen. Allow container to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

PRECAUTIONS

Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort.

Significant losses of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with DIANEAL peritoneal dialysis solutions. It is also not known whether DIANEAL peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DIANEAL peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed.

Do not administer unless solution is clear and seal is intact.

ADVERSE REACTIONS

Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a chronic peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome, and muscle cramping.

DOSAGE AND ADMINISTRATION

DIANEAL PD-2 solutions are intended for intraperitoneal administration only.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The mode of therapy (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory Peritoneal Dialysis [CAPD], or Continuous Cyclic Peritoneal Dialysis [CCPD]), frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient.

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.

Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. (See Directions for Use)

The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the solution drainage contains fibrinous or proteinaceous material (Ribot et al. 1966). 1000 to 2000 USP units of heparin per liter of solution has been recommended for adults (Furman et al. 1978). For children, 50 units of heparin per 100 mL of dialysis fluid has been recommended (Irwin et al. 1981).

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgement of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

Intermittent Peritoneal Dialysis (IPD)

For maintenance dialysis of chronic renal failure patients.

The cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially over a period of hours (8 to 36 hours) as many times per week as indicated by the condition of the patient. For chronic renal failure patients, maintenance dialysis is often accomplished by periodic dialysis (3 to 5 times weekly) for shorter time periods (8 to 14 hours per session) (Mattocks and El-Bassiouni 1971).

Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cyclic Peritoneal Dialysis (CCPD)

For maintenance dialysis of chronic renal failure patients.

In CAPD, 1.5 to 3.0 liters of dialysis solution (depending upon patient size) are instilled into the peritoneal cavity of adults and the peritoneal access device is then clamped (Kim et al. 1984; Twardowski and Janicka 1981; Twardowski and Burrows 1984). For children, 30 to 50 mL/kg body weight with a maximum of 2 liters has been recommended (Potter et al. 1981; Irwin et al. 1981). The solution remains in the cavity for dwell times of 4 to 8 hours during the day and 8 to 12 hours overnight. At the conclusion of each dwell period, the access device is opened, the solution drained and fresh solution instilled. The procedure is repeated 3 to 5 times per day, 6 to 7 days per week. Solution exchange volumes and frequency of exchanges should be individualized for adequate biochemical and fluid volume control (Moncrief et al. 1982; Twardowski et al. 1983). The majority of exchanges will utilize 1.5% or 2.5% dextrose containing peritoneal dialysis solutions, with 3.5% or 4.25% dextrose containing solutions being used when extra fluid removal is required. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978).

In CCPD, the patient receives 3 or 4 dialysis exchanges during the night which range from 2-1/2 to 3 hours dwell duration. Typically 1.5 to 2.0 liters of dialysis solution (depending upon patient size) are delivered each cycle by an automatic peritoneal dialysis cycler machine. After the last outflow during the night, an additional exchange is infused by the cycler machine into the peritoneum. The equipment is then disconnected from the patient, and the dialysate remains in the peritoneum for 14 to 15 hours during the day until the next nocturnal cycle (Diaz-Buxo et al. 1981). Combinations of 1.5% or 2.5% dextrose containing peritoneal dialysis solutions are usually used for the nighttime exchanges, while 3.5% or 4.25% dextrose is used when extra fluid removal is required such as during the daytime exchange. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978) so therapy should be individualized according to the patient’s need for ultrafiltration.

It is recommended that adult patients being placed on chronic peritoneal dialysis or, in the case of pediatric patients, the selected caretaker, (as well as the patient, when suitable), should be appropriately trained in a program which is under the supervision of a physician. Training materials are available from Baxter Healthcare Corporation, Deerfield, IL 60015, USA to facilitate this training.

HOW SUPPLIED

DIANEAL PD-2 peritoneal dialysis solutions in AMBU-FLEX II and AMBU-FLEX III containers are available in nominal size flexible containers with fill volumes and dextrose concentrations as indicated in Table 1.

All DIANEAL PD-2 peritoneal dialysis solutions have overfills which are declared on container labeling.

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.

Directions for Use

Use aseptic technique.

For complete system preparation, see directions accompanying ancillary equipment.

Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. Check for minute leaks by squeezing container firmly.

To Add Medication

Additives may be incompatible.

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

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

Preparation for Administration

  1. Put on mask. Clean and/or disinfect hands.
  2. Place solution container on work surface.
  3. Remove pull ring from connector of the solution container. If continuous fluid flow from connector is observed, discard solution container.
  4. Remove tip protector from tubing set and immediately attach to connector of the solution container.
  5. Continue with therapy set-up as instructed in user manual or directions accompanying tubing sets.
  6. Upon completion of therapy, discard unused portion.

REFERENCES

  1. Diaz-Buxo, J.A. et al. 1981. Continuous cyclic peritoneal dialysis: a preliminary report. Int Soc Artif Organs 81:157-161.
  2. Diaz-Buxo, J.A. et al. 1983. Observations on inadequate base buffer concentrations in peritoneal dialysis solutions. ASAIO Abstracts 43.
  3. Furman, K.l. et al. 1978. Activity of intraperitoneal heparin during peritoneal dialysis. Clinical Nephrology 9:15-18.
  4. Irwin, M.A. et al. 1981. Continuous ambulatory peritoneal dialysis in pediatrics. AANNT J 8:11-13,44.
  5. Kim, D. et al. 1984. Continuous ambulatory peritoneal dialysis with three-liter exchanges: a prospective study. Peritoneal Dial Bull 4:82-85.
  6. La Greca, G. et al. 1980. Acid base balance on peritoneal dialysis. Clinical Nephrology 16(1):1- 6.
  7. Mattocks, A.M. and El-Bassiouni, E.A. 1971. Peritoneal dialysis: a review. J Pharm Sci 60:1767-1782.
  8. Moncrief, J.W. et al. 1982. CAPD: Are three exchanges per day adequate? AANNT J 9:39-43.
  9. Nolph, K.D. et al. 1981. Considerations for dialysis solution modifications. In Peritoneal Dialysis, eds. Robert C. Atkins et al. Chapter 25. New York: Churchill Livingston.
  10. Popovich, R.P. et al. 1978. Continuous ambulatory peritoneal dialysis. Ann Intern Med 8:449-456.
  11. Potter, D.E. et al. 1981. Continuous ambulatory dialysis (CAPD) in children. Trans Am Soc Artif Intern Organs 27:64-67.
  12. Ribot, S. et al. 1966. Complications of peritoneal dialysis. Am J Med Sci 252:505-517.
  13. Twardowski, Z.J. and Janicka, L. 1981. Three exchanges with a 2.5 liter volume for continuous ambulatory peritoneal dialysis. Kidney Int 20:281-284.
  14. Twardowski, Z.J. et al. 1983. High volume low frequency continuous ambulatory peritoneal dialysis. Kidney Int 23:64-70.
  15. Twardowski, Z.J. and Burrows, L. 1984. Two year experience with high volume, low frequency continuous ambulatory peritoneal dialysis. Peritoneal Dial Bull 4:S67.
  16. Vaamonde, C.A. and Perez, G.O. 1977. Peritoneal dialysis today. Kidney 10:31-36.
Table 1.
Composition/
100 mL
Osmolarity
(mOsmol/L) (calc)
pH Ionic Concentration
(mEq/L)
How Supplied
*Dextrose, Hydrous, USP Sodium Chloride,USP (NaCl) Sodium Lactate
(C3H5NaO3)
Calcium Chloride, USP
(CaCl2•2H2O)
Magnesium Chloride, USP
(MgCl2•6H2O)
Sodium Calcium Magnesium Chloride Lactate Fill
Volume
(mL)
Container
Size
(mL)
Code NDC
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
AMBU-FLEX II CONTAINER
1.5g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 1000
2000
2500
3000
5000
6000
1000
3000
3000
3000
6000
6000
L5B5163
L5B5166
L5B5168
L5B5169
L5B5193
L5B9710
NDC 0941-0411-05
NDC 0941-0411-06
NDC 0941-0411-08
NDC 0941-0411-04
NDC 0941-0411-07
NDC 0941-0411-11
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
AMBU-FLEX III CONTAINER
1.5 g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 250
500
750
1000
1500
2000
2500
3000
5000
6000
500
1000
1000
1000
2000
2000
3000
3000
5000
6000
5B5160
5B5161
5B5162
5B5163
5B5165
5B5166
5B5168
5B5169
5B5193
5B9710
NDC 0941‑0411‑40
NDC 0941-0411-41
NDC 0941-0411-42
NDC 0941-0411-43
NDC 0941-0411-45
NDC 0941-0411-46
NDC 0941-0411-48
NDC 0941-0411-49
NDC 0941-0411-25
NDC 0941-0411-28
Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
AMBU-FLEX II CONTAINER
2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 1000
2000
2500
3000
5000
6000
1000
3000
3000
3000
6000
6000
L5B5173
L5B5177
L5B5178
L5B5179
L5B5194
L5B9711
NDC 0941-0413-05
NDC 0941-0413-06
NDC 0941-0413-08
NDC 0941-0413-04
NDC 0941-0413-07
NDC 0941-0413-01
Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
AMBU-FLEX III CONTAINER
2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 250
500
750
1000
1000
1500
2000
2500
3000
5000
6000
500
1000
1000
1000
2000
2000
3000
3000
3000
5000
6000
5B5170
5B5171
5B5172
5B5173
5B5174
5B5175
5B5177
5B5178
5B5179
5B5194
5B9711
NDC 0941-0413-40
NDC 0941-0413-41
NDC 0941-0413-42
NDC 0941-0413-43
NDC 0941-0413-44
NDC 0941-0413-45
NDC 0941-0413-47
NDC 0941-0413-48
NDC 0941-0413-49
NDC 0941-0413-25
NDC 0941-0413-28
Dianeal PD-2 Peritoneal Dialysis Solution with 3.5% Dextrose 3.5 g 538 mg 448 mg 25.7 mg 5.08 mg 447 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 2500 3000 5B4804 NDC 0941‑0423‑48
Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
AMBU-FLEX II CONTAINER
4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 1000
2000
2500
3000
5000
6000
1000
3000
3000
3000
6000
6000
L5B5183
L5B5187
L5B5188
L5B5189
L5B5195
L5B9712
NDC 0941-0415-05
NDC 0941-0415-06
NDC 0941-0415-08
NDC 0941-0415-04
NDC 0941-0415-07
NDC 0941-0415-01
Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
AMBU-FLEX III CONTAINER
4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40 250
500
750
1000
1000
1500
2000
2500
3000
5000
6000
500
1000
1000
1000
2000
2000
3000
3000
3000
5000
6000
5B5180
5B5181
5B5182
5B5183
5B5184
5B5185
5B5187
5B5188
5B5189
5B5195
5B9712
NDC 0941‑0415‑40
NDC 0941-0415-41
NDC 0941-0415-42
NDC 0941-0415-43
NDC 0941-0415-44
NDC 0941-0415-45
NDC 0941-0415-47
NDC 0941-0415-48
NDC 0941-0415-49
NDC 0941-0415-25
NDC 0941-0415-28
Dextrose Hydrous, USP Strucutral Formula Image

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

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

©Copyright 1981, 1982, 1983, 1984, 1989, 2008

Baxter Healthcare Corporation.

All rights reserved.

07-19-59-178

2008/11

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Dianeal PD-2 Peritoneal Dialysis Solution with Dextrose Representative Container Label

Container Label

L5B5169
NDC 0941-0411-04

 3000 mL
(APPROX 100 mL EXCESS)

Baxter

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

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-21.5% Dextrose
Dianeal PD-2 Peritoneal Dialysis Solution AMBU-FLEX II Representative Carton Label

Carton Label

L5B5169
4-3000 ML
AMBU-FLEX II CONTAINERS

1.5%

DIANEAL PD-2 1.5% DEX
PERITONEAL DIALYSIS SOLUTION

EXP
XXXX
X

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE

(01) 50309410411044

LOT
XXXXX


DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 
dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0411
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE (DEXTROSE) DEXTROSE 1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0941-0411-05 1000 mL in 1 BAG None
2 NDC:0941-0411-06 2000 mL in 1 BAG None
3 NDC:0941-0411-07 5000 mL in 1 BAG None
4 NDC:0941-0411-40 250 mL in 1 BAG None
5 NDC:0941-0411-41 500 mL in 1 BAG None
6 NDC:0941-0411-42 750 mL in 1 BAG None
7 NDC:0941-0411-43 1000 mL in 1 BAG None
8 NDC:0941-0411-45 1500 mL in 1 BAG None
9 NDC:0941-0411-46 2000 mL in 1 BAG None
10 NDC:0941-0411-48 2500 mL in 1 BAG None
11 NDC:0941-0411-49 3000 mL in 1 BAG None
12 NDC:0941-0411-25 5000 mL in 1 BAG None
13 NDC:0941-0411-28 6000 mL in 1 BAG None
14 NDC:0941-0411-11 6000 mL in 1 BAG None
15 NDC:0941-0411-04 3000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 06/17/2010

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 
dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0413
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE (DEXTROSE) DEXTROSE 2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0941-0413-05 1000 mL in 1 BAG None
2 NDC:0941-0413-06 2000 mL in 1 BAG None
3 NDC:0941-0413-07 5000 mL in 1 BAG None
4 NDC:0941-0413-01 6000 mL in 1 BAG None
5 NDC:0941-0413-40 250 mL in 1 BAG None
6 NDC:0941-0413-41 500 mL in 1 BAG None
7 NDC:0941-0413-42 750 mL in 1 BAG None
8 NDC:0941-0413-43 1000 mL in 1 BAG None
9 NDC:0941-0413-44 1000 mL in 1 BAG None
10 NDC:0941-0413-45 1500 mL in 1 BAG None
11 NDC:0941-0413-47 2000 mL in 1 BAG None
12 NDC:0941-0413-48 2500 mL in 1 BAG None
13 NDC:0941-0413-49 3000 mL in 1 BAG None
14 NDC:0941-0413-25 5000 mL in 1 BAG None
15 NDC:0941-0413-28 6000 mL in 1 BAG None
16 NDC:0941-0413-04 3000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 06/17/2010

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 
dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0423
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE (DEXTROSE) DEXTROSE 3.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0941-0423-48 2500 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 06/17/2010

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 
dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0941-0415
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE (DEXTROSE) DEXTROSE 4.25 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0941-0415-05 1000 mL in 1 BAG None
2 NDC:0941-0415-06 2000 mL in 1 BAG None
3 NDC:0941-0415-04 3000 mL in 1 BAG None
4 NDC:0941-0415-07 5000 mL in 1 BAG None
5 NDC:0941-0415-40 250 mL in 1 BAG None
6 NDC:0941-0415-41 500 mL in 1 BAG None
7 NDC:0941-0415-42 750 mL in 1 BAG None
8 NDC:0941-0415-43 1000 mL in 1 BAG None
9 NDC:0941-0415-44 1000 mL in 1 BAG None
10 NDC:0941-0415-45 1500 mL in 1 BAG None
11 NDC:0941-0415-47 2000 mL in 1 BAG None
12 NDC:0941-0415-48 2500 mL in 1 BAG None
13 NDC:0941-0415-49 3000 mL in 1 BAG None
14 NDC:0941-0415-25 5000 mL in 1 BAG None
15 NDC:0941-0415-28 6000 mL in 1 BAG None
16 NDC:0941-0415-01 6000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017512 06/17/2010

Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE CORPORATION 059140764 MANUFACTURE

Revised: 06/2010 Baxter Healthcare Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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