FDA Label for Dianeal Low Calcium With Dextrose
View Indications, Usage & Precautions
Dianeal Low Calcium With Dextrose 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
FNB5203
5000 mL
BaxterLogo
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal
Dialysis Solution with 4.25% Dextrose
EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP
448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP
5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 to 6.5)
mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40
OSMOLARITY 483 mOsmol/L (CALC)
STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT
POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN
WARNING
EXTENSIVE USE OF THIS SOLUTION DURING ONE PERITONEAL DIALYSIS PROCEDURE
CAN RESULT IN SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
FOR INTRAPERITONEAL ADMINISTRATION ONLY
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
BAXTER HEALTHCARE SA, SINGAPORE BRANCH AMBU-FLEXCONTAINER PL-146
2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778
(AN AFFLIATE OF BAXTER HEALTHCARE CORPORATION USA)
SINGAPORE SIN6625P THAILAND 2C65/45 PHILIPPINES DR-XY20804 BRUNEI BRU12120968NP
HONG KONG HK-35010 VIETNAM VN-21179-18 MALAYSIA MAL09062144AZ
BAXTER HEALTHCARE (MALAYSIA) SDN, BHD.
B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A,47301 PJ, SELANGOR
DIRECTIONS TO BE USED AS DIRECTED BY PHYSICIAN
JAUHI DARIPADA KANAK-KANAK
Controlled medicine/Ubat terkawal
Baxter Healthcare SA, Singapore Branch
10 5 TEL 6262-7100
DIANEAL, AMBU-FLEX & PL-146are trademarks of Baxter International Inc.
PVCsymbol
3A-00004
FNB5203GN
4.25% DEX
DIANEAL LOW CALCIUM PD-4
2 X 5000 ML
MAL 09062144AZ
Barcode
Lot:
Barcode
4.25%
(2.5mEq/L)
022298
Barcode
18806101552030
LOT: S24A12345 EXP: 12.12.2024
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