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FDA Drug information

DIANEAL LOW CALCIUM WITH DEXTROSE

Read time: 1 mins
Marketing start date: 26 Jan 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 DIANEAL PD-2 WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION

Brand Name

DIANEAL LOW CALCIUM WITH DEXTROSE

Generic Name

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

Product Ndc

0941-0696

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 6AB5177E 2000ml (APPROX 80ml EXCESS) 3000ml NOMINAL SIZE CONTAINER Baxter Logo Dianeal® PD-2 Peritoneal Dialysis Solution With 2.5% Dextrose EACH 100ml 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 (4.5 to 6.5) mEq/L SODIUM 132 CALCIUM 3.5 MAGNESIUM 0.5 CHLORIDE 96 LACTATE 40 OSMOLARITY 396 mOsmol/L(CALC) STERILE NON PYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSERT FOR FULL INFORMATION 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 STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (UNDER 25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex TM III CONTAINER PL-146 ® PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFILIATE OF BAXTER WORLD TRADE INC USA) HK-42533 DIRECTIONS TO BE USED AS DIRECTED BY THE PHYSICIAN Prescription Drug Manufacturer Address: Jiaoyuan Road, Dongji Industrial District, GETDD, Guangzhou, P.R. China 2.5 PD-2 WITH 2.5% DEXTROSE 2000mlX6 LOT G00000000 EXP JAN 00 6AB5177E S/N 0000 6AB9747E 2000ml (APPROX 80ml EXCESS) 3000ml NOMINAL SIZE CONTAINER Baxter Logo Dianeal® Low Calcium(2.5mEq/L) Peritoneal Dialysis Solution With 4.25% Dextrose EACH 100ml 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 (4.5 to 6.5) mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY 483 mOsmol/L(CALC) STERILE NON PYROGENIC 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 READ PACKAGE INSERT FOR FULL INFORMATION 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 STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (UNDER 25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex TM III CONTAINER PL-146 ® PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFILIATE OF BAXTER WORLD TRADE INC USA) HK-42532 DIRECTIONS TO BE USED AS DIRECTED BY THE PHYSICIAN Prescription Drug Manufacturer Address: Jiaoyuan Road, Dongji Industrial District, GETDD, Guangzhou, P.R. China 4.25 LOW CALCIUM WITH 4.25% DEXTROSE 2000mlX6 LOT G00000000 EXP JAN 00 6AB9747E S/N 0000 Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label

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