Extraneal Peritoneal Dialysis Solution With 7.5% Icodextrin

Drug Facts

Composition & Product

Active Ingredients

Icodextrin (7.5 g) Chloride Ion (538 mg) Lactic Acid, Unspecified Form (448 mg)

Inactive Ingredients

Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Completed Since 2024-10-23 Until 2027-02-12

Medication Information

Description

FNB4984 2000 mL (APPROX 80 mL EXCESS) Baxter Logo EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin EACH 100 mL CONTAINS 7.5 G ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 to 6.0) mmol/L SODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40 OSMOLARITY 284 mOsmol/L (CALC) STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT FOR INRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE 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 MANUFACTURED BY BAXTER HEALTHCARE SA, SINGAPORE BRANCH 2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778 (AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA) DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN FOR HONG KONG ONLY: PRESCRIPTION DRUG IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK FOR INDONESIA ONLY: HARUS DENGAN RESEP DOKTER IMPORTED & MARKETED BY PT KALBE FARMA TBK, BEKSAI – INDONESIA FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK PRODUCT REGISTRATION HOLDER: BAXTER HEALTHCARE (MALAYSIA) SDN. BHD., B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA ULTRABAG CONTAINER PL-146 SIN11220P MAL06021264AZ HK-46627 BRU15011744P INDONESIA DKI 0915600242A1 THAI REG. NO. 2C 16/51 (N) 30 023687 2 95 28 EXTRANEAL, UL-TRABAG and PL-146 are trademarks of Baxter International Inc. 3A-00004 FNB4984SG barcode Lot: barcode 7.5% ICODEXTRIN EXTRANEAL 6 X 2000 ML ULTRABAG MAL 06021264AZ 023687 Barcode 18806466008418 LOT: S24A12345 EXP: 12.12.2024

Health Care Provider Letter

Package/label Principal Display Panel

FNB4984

2000 mL

(APPROX 80 mL EXCESS)

BaxterLogo

EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

EACH 100 mL CONTAINS

7.5 G ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 to 6.0)

mmol/LSODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40

OSMOLARITY284 mOsmol/L (CALC)

STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT

FOR INRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE

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

MANUFACTURED BY

BAXTER HEALTHCARE SA, SINGAPORE BRANCH

2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778

(AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA)

DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN

FOR HONG KONG ONLY: PRESCRIPTION DRUG

IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK

FOR INDONESIA ONLY: HARUS DENGAN RESEP DOKTER

IMPORTED & MARKETED BY PT KALBE FARMA TBK, BEKSAI – INDONESIA

FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK

PRODUCT REGISTRATION HOLDER: BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.,

B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA

ULTRABAGCONTAINER PL-146

SIN11220P MAL06021264AZ

HK-46627 BRU15011744P

INDONESIA DKI 0915600242A1

THAI REG. NO. 2C 16/51 (N)

30

023687

2 95 28

EXTRANEAL, UL-TRABAG and PL-146are trademarks of Baxter International Inc.

3A-00004

FNB4984SG

barcode

Lot:

barcode

7.5% ICODEXTRIN

EXTRANEAL

6 X 2000 ML

ULTRABAG MAL 06021264AZ

023687

Barcode

18806466008418

LOT: S24A12345

EXP: 12.12.2024

Structured Label Content

Health Care Provider Letter

Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

FNB4984

2000 mL

(APPROX 80 mL EXCESS)

BaxterLogo

EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

EACH 100 mL CONTAINS

7.5 G ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 to 6.0)

mmol/LSODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40

OSMOLARITY284 mOsmol/L (CALC)

STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT

FOR INRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE

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

MANUFACTURED BY

BAXTER HEALTHCARE SA, SINGAPORE BRANCH

2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778

(AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA)

DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN

FOR HONG KONG ONLY: PRESCRIPTION DRUG

IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK

FOR INDONESIA ONLY: HARUS DENGAN RESEP DOKTER

IMPORTED & MARKETED BY PT KALBE FARMA TBK, BEKSAI – INDONESIA

FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK

PRODUCT REGISTRATION HOLDER: BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.,

B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA

ULTRABAGCONTAINER PL-146

SIN11220P MAL06021264AZ

HK-46627 BRU15011744P

INDONESIA DKI 0915600242A1

THAI REG. NO. 2C 16/51 (N)

30

023687

2 95 28

EXTRANEAL, UL-TRABAG and PL-146are trademarks of Baxter International Inc.

3A-00004

FNB4984SG

barcode

Lot:

barcode

7.5% ICODEXTRIN

EXTRANEAL

6 X 2000 ML

ULTRABAG MAL 06021264AZ

023687

Barcode

18806466008418

LOT: S24A12345

EXP: 12.12.2024

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ICODEXTRIN", "unii": "2NX48Z0A9G", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "538", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "LACTIC ACID, UNSPECIFIED FORM", "unii": "33X04XA5AT", "classCode": "ACTIB", "strengthNumerator": "448", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "25.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "5.08", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"PACKAGE/LABEL PRINCIPAL DISPLAY PANEL": "FNB4984 2000 mL (APPROX 80 mL EXCESS) Baxter Logo EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin EACH 100 mL CONTAINS 7.5 G ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 to 6.0) mmol/L SODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40 OSMOLARITY 284 mOsmol/L (CALC) STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT FOR INRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE 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 MANUFACTURED BY BAXTER HEALTHCARE SA, SINGAPORE BRANCH 2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778 (AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA) DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN FOR HONG KONG ONLY: PRESCRIPTION DRUG IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK FOR INDONESIA ONLY: HARUS DENGAN RESEP DOKTER IMPORTED & MARKETED BY PT KALBE FARMA TBK, BEKSAI – INDONESIA FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK PRODUCT REGISTRATION HOLDER: BAXTER HEALTHCARE (MALAYSIA) SDN. BHD., B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA ULTRABAG CONTAINER PL-146 SIN11220P MAL06021264AZ HK-46627 BRU15011744P INDONESIA DKI 0915600242A1 THAI REG. NO. 2C 16/51 (N) 30 023687 2 95 28 EXTRANEAL, UL-TRABAG and PL-146 are trademarks of Baxter International Inc. 3A-00004 FNB4984SG barcode Lot: barcode 7.5% ICODEXTRIN EXTRANEAL 6 X 2000 ML ULTRABAG MAL 06021264AZ 023687 Barcode 18806466008418 LOT: S24A12345 EXP: 12.12.2024"}

Extraneal Peritoneal Dialysis Solution With 7.5% Icodextrin

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information