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  • EXTRANEAL CALCIUM CHLORIDE 25.7 mg/100mL Baxter Healthcare Corporation
FDA Drug information

EXTRANEAL

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

EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride WATER HYDROCHLORIC ACID SODIUM HYDROXIDE ICODEXTRIN ICODEXTRIN 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

EXTRANEAL

Generic Name

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Product Ndc

0941-0707

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

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 Representative Extraneal Container Label - FNB4984SG - 0941-0707 Representative Extraneal Carton Label - FNB4984SG - 0941-0707

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