EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution
Vantive US Healthcare LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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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
| EXTRANEAL
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution |
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| Labeler - Vantive US Healthcare LLC (119181963) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Vantive Manufacturing Pte. Ltd. | 599464843 | analysis(0941-0707) , label(0941-0707) , manufacture(0941-0707) , pack(0941-0707) , sterilize(0941-0707) | |