FDA Label for Extraneal
View Indications, Usage & Precautions
Extraneal Product Label
The following document was submitted to the FDA by the labeler of this product Vantive Us Healthcare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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