Dianeal Low Calcium With Dextrose

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Dextrose (4.25 g) Chloride Ion (538 mg) Lactic Acid, Unspecified Form (448 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Completed Since 2024-10-28 Until 2026-12-13

Medication Information

Description

FNB5203 5000 mL Baxter Logo DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 to 6.5) mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY 483 mOsmol/L (CALC) STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN 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 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 KEEP OUT OF REACH OF CHILDREN BAXTER HEALTHCARE SA, SINGAPORE BRANCH AMBU-FLEX CONTAINER PL-146 2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778 (AN AFFLIATE OF BAXTER HEALTHCARE CORPORATION USA) SINGAPORE SIN6625P THAILAND 2C65/45 PHILIPPINES DR-XY20804 BRUNEI BRU12120968NP HONG KONG HK-35010 VIETNAM VN-21179-18 MALAYSIA MAL09062144AZ BAXTER HEALTHCARE (MALAYSIA) SDN, BHD. B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A,47301 PJ, SELANGOR DIRECTIONS TO BE USED AS DIRECTED BY PHYSICIAN JAUHI DARIPADA KANAK-KANAK Controlled medicine/Ubat terkawal Baxter Healthcare SA, Singapore Branch 10 5 TEL 6262-7100 DIANEAL, AMBU-FLEX & PL-146 are trademarks of Baxter International Inc. PVC symbol 3A-00004 FNB5203GN 4.25% DEX DIANEAL LOW CALCIUM PD-4 2 X 5000 ML MAL 09062144AZ Barcode Lot: Barcode 4.25% (2.5mEq/L) 022298 Barcode 18806101552030 LOT: S24A12345 EXP: 12.12.2024

Health Care Provider Letter

Package/label Principal Display Panel

FNB5203

5000 mL

BaxterLogo

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal

Dialysis Solution with 4.25% Dextrose

EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP

448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP

5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 to 6.5)

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

OSMOLARITY 483 mOsmol/L (CALC)

STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

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

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 KEEP OUT OF REACH OF CHILDREN

BAXTER HEALTHCARE SA, SINGAPORE BRANCH AMBU-FLEXCONTAINER PL-146

2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778

(AN AFFLIATE OF BAXTER HEALTHCARE CORPORATION USA)

SINGAPORE SIN6625P THAILAND 2C65/45 PHILIPPINES DR-XY20804 BRUNEI BRU12120968NP

HONG KONG HK-35010 VIETNAM VN-21179-18 MALAYSIA MAL09062144AZ

BAXTER HEALTHCARE (MALAYSIA) SDN, BHD.

B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A,47301 PJ, SELANGOR

DIRECTIONS TO BE USED AS DIRECTED BY PHYSICIAN

JAUHI DARIPADA KANAK-KANAK

Controlled medicine/Ubat terkawal

Baxter Healthcare SA, Singapore Branch

10 5 TEL 6262-7100

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

PVCsymbol

3A-00004

FNB5203GN

4.25% DEX

DIANEAL LOW CALCIUM PD-4

2 X 5000 ML

MAL 09062144AZ

Barcode

Lot:

Barcode

4.25%

(2.5mEq/L)

022298

Barcode

18806101552030

LOT: S24A12345 EXP: 12.12.2024

Structured Label Content

Health Care Provider Letter

Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)