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FDA Drug information

DIANEAL LOW CALCIUM WITH DEXTROSE

Read time: 1 mins
Marketing start date: 04 Apr 2025
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Summary of product characteristics


Effective Time

20241107

Version

2

Spl Product Data Elements

DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION

Brand Name

DIANEAL LOW CALCIUM WITH DEXTROSE

Generic Name

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

Product Ndc

0941-0705

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 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 Representative Dianeal Container Label - FNB5203GN - 0941-0705.jpg Representative Dianeal Carton Label - FNB5203GN - 0941-0705.jpg

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