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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 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 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

0941-0688

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 6AB9768E 2500ml (APPROX 90ml EXCESS) 3000ml NOMINAL SIZE CONTAINER Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) Peritoneal Dialysis Solution With 1.5% Dextrose EACH 100 ml CONTAINS 1.5g 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 344 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 (UNDER25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ultrabag TM CONTAINER PL-146 PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFILIATE OF BAXTER WORLD TRADE INC USA) HK-62710 DIRECTIONS TO BE USED AS DIRECTED BY THE PHYSICIAN Prescription Drug Manufacturer Address: Jiaoyuan Road, Dongji Industrial District, GETDD, Guangzhou, P.R. China Low Calcium 1.5% Dextrose 1.5 LOW CALCIUM WITH 1.5% DEXTROSE ULTRABAG 2500mlX4 LOT G00000000 EXP JAN 00 6AB9768E S/N 0000 6AB9778E 2500ml (APPROX 90ml EXCESS) 3000ml NOMINAL SIZE CONTAINER Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) Peritoneal Dialysis Solution With 2.5% Dextrose EACH 100ml CONTAINS 2.5g 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 395 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 (UNDER25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ultrabag TM CONTAINER PL-146 PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFILIATE OF BAXTER WORLD TRADE INC USA) HK-62709 DIRECTIONS TO BE USED AS DIRECTED BY THE PHYSICIAN Prescription Drug Manufacturer Address: Jiaoyuan Road, Dongji Industrial District, GETDD, Guangzhou, P.R. China Low Calcium 2.5% Dextrose 2.5 LOW CALCIUM WITH 2.5% DEXTROSE ULTRABAG 2500mlX4 LOT G00000000 EXP JAN 00 6AB9778E S/N 0000 6AB9798E 2500ml (APPROX 90ml EXCESS) 3000ml NOMINAL SIZE CONTAINER Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) Peritoneal Dialysis Solution With 4.25% Dextrose EACH 100ml CONTAINS 4.25g 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 (UNDER25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ultrabag TM CONTAINER PL-146 PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFILIATE OF BAXTER WORLD TRADE INC USA) HK-62711 DIRECTIONS TO BE USED AS DIRECTED BY THE PHYSICIAN Prescription Drug Manufacturer Address: Jiaoyuan Road, Dongji Industrial District, GETDD, Guangzhou, P.R. China Low Calcium 4.25% Dextrose 4.25 LOW CALCIUM WITH 4.25% DEXTROSE ULTRABAG 2500mlX4 LOT G00000000 EXP JAN 00 6AB9798E S/N 0000 Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label

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