Dianeal Low Calcium With Dextrose

Dianeal Low Calcium With Dextrose
SPL v3
SPL
SPL Set ID a829d4eb-3ec5-453c-b270-793969af15b3
Route
INTRAPERITONEAL
Published
Effective Date 2024-11-07
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dextrose (1.5 g) Chloride Ion (538 mg) Lactic Acid, Unspecified Form (448 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Completed Since 2024-11-07 Until 2026-12-31

Description

6AB9770E 6000ml (APPROX 225ml EXCESS) Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) Peritoneal Dialysis Solution With 1.5% Dextrose EACH 100ml CONTAINS 1.5 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 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 (UNDER 25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex™ III CONTAINER PL-146 ® PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFI LIATE OF BAXTER WORLD TRADE INC USA) HK-42530 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 6000mlX2 LOT G00000000 EXP JAN 00 6AB9770E S/N 0000 6AB9771E 6000ml (APPROX 225ml EXCESS) Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) 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 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 (UNDER 25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex™ III CONTAINER PL-146 ® PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFI LIATE OF BAXTER WORLD TRADE INC USA) HK-42531 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 2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2 LOT G00000000 EXP JAN 00 6AB9771E S/N 0000


Medication Information

Description

6AB9770E 6000ml (APPROX 225ml EXCESS) Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) Peritoneal Dialysis Solution With 1.5% Dextrose EACH 100ml CONTAINS 1.5 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 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 (UNDER 25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex™ III CONTAINER PL-146 ® PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFI LIATE OF BAXTER WORLD TRADE INC USA) HK-42530 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 6000mlX2 LOT G00000000 EXP JAN 00 6AB9770E S/N 0000 6AB9771E 6000ml (APPROX 225ml EXCESS) Baxter Logo Dianeal ® Low Calcium(2.5mEq/L) 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 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 (UNDER 25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex™ III CONTAINER PL-146 ® PLASTIC MANUFACTURED BY BAXTER HEALTHCARE (GUANGZHOU) CO LTD GUANGZHOU CHINA (AN AFFI LIATE OF BAXTER WORLD TRADE INC USA) HK-42531 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 2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2 LOT G00000000 EXP JAN 00 6AB9771E S/N 0000

Health Care Provider Letter
Package/label Principal Display Panel

6AB9770E 6000ml

(APPROX 225ml EXCESS)

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 1.5% Dextrose

EACH 100ml CONTAINS1.5 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 pH5.2 (4.5 TO 6.5)

mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5

CHLORIDE 95 LACTATE 40

OSMOLARITY344 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

CAUTIONSSQUEEZE 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™ IIICONTAINER PL-146 ®PLASTIC

MANUFACTURED BY

BAXTER HEALTHCARE (GUANGZHOU) CO LTD

GUANGZHOU CHINA

(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)

HK-42530

DIRECTIONSTO 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 6000mlX2

LOT G00000000 EXP JAN 00 6AB9770E S/N 0000

6AB9771E 6000ml

(APPROX 225ml EXCESS)

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 2.5% Dextrose

EACH 100ml CONTAINS2.5 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 pH5.2 (4.5 TO 6.5)

mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5

CHLORIDE 95 LACTATE 40

OSMOLARITY395 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

CAUTIONSSQUEEZE 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™ IIICONTAINER PL-146 ®PLASTIC

MANUFACTURED BY

BAXTER HEALTHCARE (GUANGZHOU) CO LTD

GUANGZHOU CHINA

(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)

HK-42531

DIRECTIONSTO 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

2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2

LOT G00000000 EXP JAN 00 6AB9771E S/N 0000


Structured Label Content

Health Care Provider Letter
Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

6AB9770E 6000ml

(APPROX 225ml EXCESS)

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 1.5% Dextrose

EACH 100ml CONTAINS1.5 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 pH5.2 (4.5 TO 6.5)

mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5

CHLORIDE 95 LACTATE 40

OSMOLARITY344 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

CAUTIONSSQUEEZE 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™ IIICONTAINER PL-146 ®PLASTIC

MANUFACTURED BY

BAXTER HEALTHCARE (GUANGZHOU) CO LTD

GUANGZHOU CHINA

(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)

HK-42530

DIRECTIONSTO 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 6000mlX2

LOT G00000000 EXP JAN 00 6AB9770E S/N 0000

6AB9771E 6000ml

(APPROX 225ml EXCESS)

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 2.5% Dextrose

EACH 100ml CONTAINS2.5 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 pH5.2 (4.5 TO 6.5)

mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5

CHLORIDE 95 LACTATE 40

OSMOLARITY395 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

CAUTIONSSQUEEZE 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™ IIICONTAINER PL-146 ®PLASTIC

MANUFACTURED BY

BAXTER HEALTHCARE (GUANGZHOU) CO LTD

GUANGZHOU CHINA

(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)

HK-42531

DIRECTIONSTO 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

2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2

LOT G00000000 EXP JAN 00 6AB9771E S/N 0000


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