Dianeal Low Calcium With Dextrose

Dianeal Low Calcium With Dextrose
SPL v4
SPL
SPL Set ID b0f2c9a2-d9d4-4907-a324-e7a26d489f44
Route
INTRAPERITONEAL
Published
Effective Date 2024-11-01
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)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Completed Since 2024-11-01 Until 2026-12-31

Description

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


Medication Information

Description

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

Health Care Provider Letter
Package/label Principal Display Panel

6AB9768E 2500ml

(APPROX 90ml EXCESS)

3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 1.5% Dextrose

EACH 100 ml CONTAINS1.5g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP 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 (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

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

ULTRABAG 2500mlX4

LOT G00000000 EXP JAN 00

6AB9768E

S/N 0000

6AB9778E 2500ml

(APPROX 90ml EXCESS)

3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 2.5% Dextrose

EACH 100ml CONTAINS2.5g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP 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 (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

DIRECTIONSTO 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

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 4.25% Dextrose

EACH 100ml CONTAINS4.25g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP pH5.2 (4.5 to 6.5)

mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5

CHLORIDE 95 LACTATE 40 OSMOLARITY483 mOsmol/L(CALC)

STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER

THE DIRECTION OF A PHYSICIAN

WARNINGEXTENSIVE 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

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 (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

DIRECTIONSTO 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


Structured Label Content

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

6AB9768E 2500ml

(APPROX 90ml EXCESS)

3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 1.5% Dextrose

EACH 100 ml CONTAINS1.5g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP 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 (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

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

ULTRABAG 2500mlX4

LOT G00000000 EXP JAN 00

6AB9768E

S/N 0000

6AB9778E 2500ml

(APPROX 90ml EXCESS)

3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 2.5% Dextrose

EACH 100ml CONTAINS2.5g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP 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 (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

DIRECTIONSTO 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

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)

Peritoneal Dialysis Solution

With 4.25% Dextrose

EACH 100ml CONTAINS4.25g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP pH5.2 (4.5 to 6.5)

mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5

CHLORIDE 95 LACTATE 40 OSMOLARITY483 mOsmol/L(CALC)

STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER

THE DIRECTION OF A PHYSICIAN

WARNINGEXTENSIVE 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

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 (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

DIRECTIONSTO 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


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