Extraneal Injection, Solution
FDA Label NDC 0941-0707

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vantive Us Healthcare Llc for the product Extraneal (NDC 0941-0707). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Representative Extraneal Container Label (FNB4984SG)

Representative Extraneal Container Label (FNB4984SG)

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.

Representative Extraneal Carton Label (FNB4984SG)

Representative Extraneal Carton Label (FNB4984SG)

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

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