DIANEAL FOR PERITONEAL DIALYSIS

DIANEAL FOR PERITONEAL DIALYSIS- anhydrous dextrose, sodium chloride, sodium lactate, calcium chloride and magnesium chloride injection, solution
Baxter Healthcare Corporation

IMPORTANT DRUG INFORMATION

October 2014

Subject: Temporary Importation of DIANEAL® Solution for Peritoneal Dialysis

Dear Healthcare Professional,

Due to current critical shortage of Dianeal peritoneal dialysis solutions for new and existing patients in the US market, Baxter Healthcare Corporation (Baxter) is coordinating with the Food and Drug Administration (FDA) to increase the availability of the drug. Baxter has initiated temporary importation of Dianeal peritoneal dialysis solutions manufactured at Baxter’s Castlebar, Ireland facility and marketed within the European Union (EU). The FDA has not approved this product in the United States.

Prior to its use, it is important to check for leaks by squeezing the inner bag firmly. If leaks are found, do not use solution as sterility may be impaired. Additionally, check to see that solution is clear and free of foreign matter. Solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage should not be used or discarded, but reported to Baxter Product Surveillance immediately. To report product quality issues, please contact Baxter Product Surveillance at 1-800-437-5176.

There are no clinically relevant differences in the composition of the European-manufactured product and the US-manufactured product (see Table 1). However, because the imported product is only available in one size (5000 ml), the number of solution bags patients use per treatment may require modification. Although the frangible, medication ports, and connection caps may appear different for the European-manufactured product, they function in a similar manner to the US-manufactured product.

Effective immediately, Baxter will offer DIANEAL PD4 Glucose Solution for Peritoneal Dialysis in flexible polyvinyl chloride bag containers in the following volume:

Automated Peritoneal Dialysis (APD) product, 5000mL container:

*
Comparable to Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with Dextrose manufactured in the US

Product *

Product Code Number NDC number
US equivalent Product Code Number and NDC number

Dianeal PD4 Glucose 1,36% w/v 13,6 mg/ml Solution for Peritoneal Dialysis

SPB5215RC NDC 0941-0464-01
L5B4826 NDC 0941-0409-07

Dianeal PD4 Glucose 2,27% w/v 22,7 mg/ml Solution for Peritoneal Dialysis

SPB5225RC NDC 0941-0465-01
L5B5202 NDC 0941-0457-05

Dianeal PD4 Glucose 3,86% w/v 38,6 mg/ml Solution for Peritoneal Dialysis

SPB5235RC NDC 0941-0466-01
L5B5203 NDC 0941-0459-05

At this time, importation or distribution of Dianeal peritoneal dialysis solution in the United States by any entity other than Baxter or its authorized distributor(s) is considered a violation of the Federal Food, Drug and Cosmetic Act and is subject to enforcement by the FDA.

Dosage and Administration

Baxter’s DIANEAL PD4 with 1,36%, 2,27%, or 3,86% Glucose Solution for Peritoneal Dialysis (manufactured in EU) has the same ionic composition as Baxter’s Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5%, 2.5%, or 4.25% Dextrose products (manufactured in US). Please note that numerical values for EU products use commas in place of decimal points for the US products. Dianeal solution concentration is expressed as % anhydrous glucose, which correlates to the following % dextrose monohydrate equivalents:

• 1.5% dextrose monohydrate (or glucose monohydrate) = 1,36% anhydrous dextrose (or anhydrous glucose)
• 2.5% dextrose monohydrate (or glucose monohydrate) = 2,27% anhydrous dextrose (or anhydrous glucose)
• 4.25% dextrose monohydrate (or glucose monohydrate) = 3,86% anhydrous dextrose (or anhydrous glucose)

As such, clinical practice for usage, administration, and dosage for DIANEAL PD4 with 1,36%, 2,27%, or 3,86% Glucose Solution for Peritoneal Dialysis (manufactured in EU) products is the same as with the Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5%, 2.5%, or 4.25% Dextrose products (manufactured in US). Please refer to the FDA-approved Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution US Package Insert for reference.

Summary of Product Differences

Before prescribing, healthcare providers should be aware of some key differences in the container packaging and labeling between the DIANEAL PD4 with Glucose Solution for Peritoneal Dialysis products (manufactured in EU) and Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with Dextrose (manufactured in US).

Key differences are highlighted in the attached Product Comparison Tables as follows:

• Table 1: Dianeal Formulation Comparison (as labeled)
• Table 2: Comparison of Dianeal container labels for APD, 5000 mL

Additional differences with photographs are highlighted in the accompanying Comparison Guide, which describes differences in shipping cartons, solution bags, and labeling.

Important Notes

• Despite visual differences in the product appearance, the Luer-lock connector is the same and is fully compatible with peritoneal dialysis sets marketed in the United States.
• Prior to use, it is important to check for leaks by squeezing the inner bag firmly. If leaks are found, do not use solution as sterility may be impaired. Additionally, check to see that solution is clear and free of foreign matter. Solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage should not be used or discarded, but reported to Baxter Product Surveillance immediately. To report product quality issues, please contact Baxter Product Surveillance at 1-800-437-5176.
• DIANEAL PD4 with Glucose Solutions imported product and carton labeling includes barcodes; however, the barcodes may not register accurately in the US scanning systems. Institutions should manually input the product into their systems and confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.

If you have any questions about the information contained in this letter or the use of DIANEAL PD4 with 1,36%, 2,27%, or 3,86% Glucose Solution for Peritoneal Dialysis products, please contact Baxter’s Medical Information Service at 1-888-736-2543, Option #2. To place an order, please contact Baxter’s Center for Service by calling 1-888-229-0001.

To report product quality issues, please contact Baxter Product Surveillance at 1-800-437-5176. To report adverse events associated with Dianeal peritoneal dialysis solutions, please call Baxter at 1-866-888-2472 or fax: 1-800-759-1801. Adverse events that may be related to the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178 (1-800-332-0178)

Sincerely,

Mary Gellens, M.D.

Baxter Healthcare Corporation

Baxter and Dianeal are registered trademarks of Baxter International Inc.

Baxter Healthcare Corporation

One Baxter Parkway

Deerfield, Illinois 60015

USMP/76/14-0013 10/2014

Table 1. Dianeal Formulation Comparison (as labeled)
*
The ionic concentration between the two products is exactly the same through different units of measure (mmol/L vs mEq/L) are used.

Product manufactured in EU

Product manufactured in US

Product name

DIANEAL PD4 Glucose Solution for Peritoneal Dialysis

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

Content

1,36% w/v / 13,6 mg/ml Formula / 1000 ml: Anhydrous Glucose 13,6 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g

1.5% Dextrose Each 100 mL contains: Dextrose Hydrous USP 1.5 g Sodium Chloride USP 538 mg Sodium Lactate 448 mg Calcium Chloride USP 18.3 mgMagnesium Chloride USP 5.08 mg

2,27% w/v / 22,7 mg/ml Formula / 1000 ml: Anhydrous Glucose 22,7 g/l Sodium Chloride 5,38 g/l Sodium Lactate 4,48 g/l Calcium Chloride 0,184 g/lMagnesium Chloride 0,051 g/l

2.5% DextroseEach 100 mL contains: Dextrose Hydrous USP 2.5 g Sodium Chloride USP 538 mg Sodium Lactate 448 mg Calcium Chloride USP 18.3 mgMagnesium Chloride USP 5.08 mg

3,86% w/v / 38,6 mg/ml Formula / 1000 ml: Anhydrous Glucose 38,6 g/l Sodium Chloride 5,38 g/l Sodium Lactate 4,48 g/l Calcium Chloride 0,184 g/l Magnesium Chloride 0,051 g/l

4.25% Dextrose

Each 100 mL contains: Dextrose Hydrous USP 4.25 g Sodium Chloride USP 538 mg Sodium Lactate 448 mg Calcium Chloride USP 18.3 mgMagnesium Chloride USP 5.08 mg

Ionic composition *

Sodium 132 mmol/L Calcium 1,25 mmol/LMagnesium 0,25 mmol/L Chloride 95 mmol/L Lactate 40 mmol/L

Sodium 132 mEq/L Calcium 2.5 mEq/L Magnesium 0.5 mEq/LChloride 95 mEq/L Lactate 40 mEq/L

Osmolarity (calculated)

1,36% Glucose: 344 mOsm/L

2,27% Glucose: 395 mOsm/L

3,86% Glucose: 483 mOsm/L

1.5% Dextrose: 344 mOsmol/L2.5% Dextrose: 395 mOsmol/L4.25% Dextrose: 483 mOsmol/L

Storage conditions

Do not store above 25°C.

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.

Table 2. Comparison of Dianeal container labels for APD, 5000 mL
(click image for full-size original)
Continuation of Table 2. Comparison of Dianeal container labels for APD, 5000 mL
(click image for full-size original)
Comparison Guide
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Differences in the shipping cartons
(click image for full-size original)
Differences in glucose/dextrose concentration and shipping carton color-coding
(click image for full-size original)
Differences in the bags clinics and patients receive
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Frangible (different colors, but function exactly the same)
(click image for full-size original)
Using Dianeal PD4 (manufactured in EU)
(click image for full-size original)
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