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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: 1 | DIANEAL PD-2 with Dextrose [Baxter Healthcare Corporation] | BioPortfolio

12:51 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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

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 1.73m 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)].

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:

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.

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;

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

Table 1 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX Container with pull ring for APD therapy
Ionic Concentration
(mEq/L)
OSMOLARITY
(mOsmol/L) (calc)
pH Sodium Calcium Magnesium Chloride Lactate
DIANEAL PD-2
1.5% Dextrose
346 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40
DIANEAL PD-2
2.5% Dextrose
396 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40
DIANEAL PD-2
4.25% Dextrose
485 5.2
(4.0 to 6.5)
132 3.5 0.5 96 40
DIANEAL Low Calcium
(2.5 mEq/L)
1.5% Dextrose
344 5.2
(4.0 to 6.5)
132 2.5 0.5 95 40
DIANEAL Low Calcium
(2.5 mEq/L)
2.5% Dextrose
395 5.2
(4.0 to 6.5)
132 2.5 0.5 95 40
DIANEAL Low Calcium
(2.5 mEq/L)
4.25% Dextrose
483 5.2
(4.0 to 6.5)
132 2.5 0.5 95 40
Table 2 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy
Ionic Concentration
(mEq/L)
OSMOLARITY
(mOsmol/L) (calc)
pH Sodium Calcium Magnesium Chloride Lactate
DIANEAL Low Calcium
(2.5 mEq/L)
1.5% Dextrose
344 5.0 to 6.5 132 2.5 0.5 95 40
DIANEAL Low Calcium
(2.5 mEq/L)
2.5% Dextrose
395 5.0 to 6.5 132 2.5 0.5 95 40
DIANEAL Low Calcium
(2.5 mEq/L)
4.25% Dextrose
483 5.0 to 6.5 132 2.5 0.5 95 40
Table 3 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with pull ring 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

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

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.

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)].

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.

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.

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.

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)]

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

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

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)].

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.

The components of DIANEAL solutions are excreted in human milk.

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.

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

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 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 6 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with pull ring for APD therapy

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.

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 Sodium Chloride (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride (CaCl2•2H2O) Magnesium Chloride (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
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 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.

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.

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

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.

Table 7 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapy
Container Fill Volume (mL) Container Size (mL) Product Code NDC
ULTRABAG
Container
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
2000 2500 3000 2000 3000 5000 5B9866 5B9868 5B9857 0941-0426-52 0941-0426-53 0941-0426-55
DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
2000 2500 3000 2000 3000 5000 5B9876 5B9878 5B9858 0941-0427-52 0941-0427-53 0941-0427-55
DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
2000 2500 3000 2000 3000 5000 5B9896 5B9898 5B9859 0941-0429-52 0941-0429-53 0941-0429-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
1500 2000 2500 3000 2000 2000 3000 5000 5B9765 5B9766 5B9768 5B9757 0941-0424-51 0941-0424-52 0941-0424-53 0941-0424-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
1500 2000 2500 3000 2000 2000 3000 5000 5B9775 5B9776 5B9778 5B9758 0941-0430-51 0941-0430-52 0941-0430-53 0941-0430-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
1500 2000 2500 3000 2000 2000 3000 5000 5B9795 5B9796 5B9798 5B9759 0941-0433-51 0941-0433-52 0941-0433-53 0941-0433-55
Table 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 pull ring 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

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 CorporationDeerfield, IL 60015 USAPrinted in USA

0719000089

 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 ATROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

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

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-615

PD-2 1.5% Dextrose

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 CODEXXXXX

(01) 50309410411068

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 - 40OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLYUNDER 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 ATROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

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

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-586

PD-2 2.5% Dextrose

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 CODEXXXXX

(01) 50309410413062

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 - 40OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLYUNDER 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 SOLUTIONDURING ONE PERITONEAL DIALYSIS PROCEDURE CANRESULT IN SIGNIFICANT REMOVAL OF WATER FROMTHE 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 ATROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

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

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-591

PD-2 4.25% Dextrose 

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 CODEXXXXX

(01) 50309410415066

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 - 40OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLYUNDER 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 ATROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

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

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-640

Low Calcium 1.5% Dextrose

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 CODEXXXXX

(01) 50309410409065

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 - 40OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLYUNDER 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 ATROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

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

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-641

Low Calcium 2.5% Dextrose

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 CODEXXXXX

(01) 50309410457080

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 - 40OSMOLARITY - 346 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLYUNDER 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 ATROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

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

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN USA 07-25-56-642

Low Calcium 4.25% Dextrose

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 CODEXXXXX

(01) 503094104590804

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 USP538 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 - 0.5CHLORIDE - 96 LACTATE - 40OSMOLARITY - 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

 

5B9866 6-2000ML IN 2000ML

ULTRABAG 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

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 USP538 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 - 40OSMOLARITY - 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

5B9876 6-2000ML IN 2000ML

ULTRABAG 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

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 USP538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE25.7 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 - 0.5CHLORIDE - 96 LACTATE - 40OSMOLARITY - 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 USEAVOID 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

5B9896 6-2000ML IN 2000ML

ULTRABAG 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

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 USP538 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 - 0.5CHLORIDE - 95 LACTATE - 40OSMOLARITY - 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

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

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 USP538 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 - 0.5CHLORIDE - 95 LACTATE - 40OSMOLARITY - 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

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

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 USP538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE18.3 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 - 0.5CHLORIDE - 95 LACTATE - 40OSMOLARITY - 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 LEAKSARE 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

5B9796 6-2000ML IN 2000ML ULTRABAG 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

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 CONTAINS1.5 g DEXTROSE HYDROUS USP538 mg SODIUM CHLORIDE USP448 mg SODIUM LACTATE18.3 mg CALCIUM CHLORIDE USP5.08 mg MAGNESIUM CHLORIDE USPpH 5.0 to 5.6

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5CHLORIDE – 95 LACTATE – 40OSMOLARITY – 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 STERILITYDISCARD IF LEAKS ARE FOUNDDO 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

PVC PLASTIC

BAXTER DIANEAL IS A TRADEMARK OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION DEERFIELD, IL 60015 USA

MADE IN MEXICO

88-80-32-995

DIANEAL LOW CALCIUM 1.5% DEX PERITONEAL DIALYSIS SOLUTION

VIAFLEX

2-6000 mL

1.5%

VBB4928US

LOT XXXXX EXP MMYYYY

VBB4928US

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 CONTAINS2.5 g DEXTROSE HYDROUS USP538 mg SODIUM CHLORIDE USP448 mg SODIUM LACTATE18.3 mg CALCIUM CHLORIDE USP5.08 mg MAGNESIUM CHLORIDE USPpH 5.0 to 5.6

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5CHLORIDE – 95 LACTATE – 40OSMOLARITY – 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 STERILITYDISCARD IF LEAKS ARE FOUNDDO 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

PVC PLASTIC

BAXTER DIANEAL IS A TRADEMARK OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA

MADE IN MEXICO

88-80-32-996

DIANEAL LOW CALCIUM 2.5% DEX PERITONEAL DIALYSIS SOLUTION

VIAFLEX

2-6000 mL

2.5%

VBB4931 US

LOT XXXXX EXP MMYYYY

EZPB5245R NDC 0941-0484-01

5000 mL (APPROX 135 mL EXCESS)

BAXTER LOGO

DianealLow Calcium (2.5 mEq/L)Peritoneal Dialysis Solutionwith 1.5% Dextrose

Low Calcium 1.5% Dextrose

EACH 100 mL CONTAINS448 mg SODIUM LACTATEpH 5.0 to 6.5

1.5 g DEXTROSE HYDROUS18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40OSMOLARITY – 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

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

DIANEAL LOW CALCIUM (2.5 mEq/L)

Peritoneal Dialysis Solutionwith 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 Solutionwith 1.5% Dextrose

LOT XXXXXXXX

EZPB5245R5000 mL x 2EXP MM/YYYY

EZPB5255R NDC 0941-0487-01

5000 mL (APPROX 135 mL EXCESS)

BAXTER LOGO

DianealLow Calcium (2.5 mEq/L)Peritoneal Dialysis Solutionwith 2.5% Dextrose

Low Calcium 2.5% Dextrose

EACH 100 mL CONTAINS448 mg SODIUM LACTATEpH 5.0 to 6.5

2.5 g DEXTROSE HYDROUS18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40OSMOLARITY – 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

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

DIANEAL LOW CALCIUM (2.5 mEq/L)

Peritoneal Dialysis Solutionwith 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 Solutionwith 2.5% Dextrose

LOT XXXXXXXX

EZPB5255R5000 mL x 2EXP MM/YYYY

EZPB5265R NDC 0941-0490-01

5000 mL (APPROX 135 mL EXCESS)

BAXTER LOGO

DianealLow Calcium (2.5 mEq/L)Peritoneal Dialysis Solutionwith 4.25% Dextrose

Low Calcium 4.25% Dextrose

EACH 100 mL CONTAINS448 mg SODIUM LACTATEpH 5.0 to 6.5

4.25 g DEXTROSE HYDROUS18.4 mg CALCIUM CHLORIDE

538 mg SODIUM CHLORIDE5.08 mg MAGNESIUM CHLORIDE

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40OSMOLARITY – 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

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

DIANEAL LOW CALCIUM (2.5 mEq/L)

Peritoneal Dialysis Solutionwith 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

Manufacturer

Baxter Healthcare Corporation

Active Ingredients

Source

Drugs and Medications [243 Associated Drugs and Medications listed on BioPortfolio]

Haemonetics anticoagulant citrate dextrose solution [haemonetics corporation]

Haemonetics Anticoagulant Citrate Dextrose Solution

Dianeal for peritoneal dialysis [baxter healthcare corporation]

DIANEAL® SOLUTION FOR PERITONEAL DIALYSIS

Diltiazem hcl [cantrell drug company]

Diltiazem HCl 250 mg in 5% Dextrose 300 mL Bag

Dextrose [baxter healthcare corporation]

5% Dextrose Injection, USP

Amiodarone hcl [cantrell drug company]

Amiodarone HCl 450 mg Added to 5% Dextrose 250 mL Bag

Clinical Trials [116 Associated Clinical Trials listed on BioPortfolio]

Zero Sodium Peritoneal Dialysate Protocol Pilot Study

The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to...

Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR

Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate i...

40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose

The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate ...

Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis

Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining pa...

Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

Participants with wrist pain on the little finger side of the wrist will received either usual care, consisting of ultrasound, specialized massage and stabilization exercises therapy for 6...

PubMed Articles [39 Associated PubMed Articles listed on BioPortfolio]

Comparison of imaged capillary isoelectric focusing and cation exchange chromatography for monitoring dextrose-mediated glycation of monoclonal antibodies in infusion solutions.

Intravenous (IV) infusion of therapeutic proteins typically involves dilution of the formulated product into infusion media such as normal saline or dextrose, 5% m/v in water. We report results from a...

Effects of hypertonic dextrose and paraffin solution as non-antibiotic treatments of clinical endometritis on reproductive performance of high producing dairy cows.

The objective of this study is to compare the reproductive performance of cows affected by clinical endometritis (CE) following treatment with an intrauterine infusion of 50% dextrose solutions (DEX) ...

Hypertonic milk replacers increase gastrointestinal permeability in healthy dairy calves.

Hypertonic milk replacers are commonly used in animal production systems and their effect on the gastrointestinal system of young animals is insufficiently studied. Total lactose inclusion or its part...

Embolization of a Complex Facial Arteriovenous Malformation, Balloon-Assisted Flow Arrest, and Controlled n-BCA Injection with Dextrose Push Technique: 2-Dimensional Operative Video.

N-butyl cyanoacrylate glue (n-BCA, Cerenovus, Irvine, California) is commonly used to treat arteriovenous malformation (AVM). Even though Onyx (ethylene vinyl alcohol, Medtronic, Dublin, Ireland) pres...

Stability of mycophenolate mofetil in polypropylene 5% dextrose infusion bags and chemical compatibility associated with the use of the EQUASHIELD® closed-system transfer device.

Stability studies are necessary in healthcare settings as they facilitate fast, cost-effective and efficient work related to batch manufacturing and availability of supplies. We studied the stability ...

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