DIANEAL LOW CALCIUM WITH DEXTROSE- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

DIANEAL LOW CALCIUM WITH DEXTROSE by

Drug Labeling and Warnings

DIANEAL LOW CALCIUM WITH DEXTROSE by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Vantive Manufacturing Pte. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

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

INGREDIENTS AND APPEARANCE

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0705
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0705-02	2 in 1 CARTON	10/28/2024
1	NDC: 0941-0705-01	5000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/28/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Vantive Manufacturing Pte. Ltd.		599464843	analysis(0941-0705) , label(0941-0705) , manufacture(0941-0705) , pack(0941-0705) , sterilize(0941-0705)