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, Baxter Healthcare (Guangzhou) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

6AB9768E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 1.5% Dextrose

EACH 100 ml CONTAINS1.5g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5
CHLORIDE 95 LACTATE 40
OSMOLARITY344 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ultrabag TMCONTAINER PL-146 PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62710
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China

Low Calcium 1.5% Dextrose

1.5 LOW CALCIUM WITH 1.5% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00

6AB9768E

S/N 0000

6AB9778E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 2.5% Dextrose

EACH 100ml CONTAINS2.5g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5
CHLORIDE 95 LACTATE 40
OSMOLARITY395 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ultrabag TMCONTAINER PL-146 PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62709
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China

Low Calcium 2.5% Dextrose

2.5 LOW CALCIUM WITH 2.5% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00

6AB9778E

S/N 0000

6AB9798E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 4.25% Dextrose

EACH 100ml CONTAINS4.25g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5
CHLORIDE 95 LACTATE 40 OSMOLARITY483 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

WARNINGEXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ultrabag TMCONTAINER PL-146 PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62711
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China

Low Calcium 4.25% Dextrose

4.25 LOW CALCIUM WITH 4.25% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00

6AB9798E

S/N 0000

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: 0941-0684
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	1.5 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: 0941-0684-04	4 in 1 CARTON	11/01/2024
1	NDC: 0941-0684-01	2500 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		11/01/2024

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: 0941-0688
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 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: 0941-0688-04	4 in 1 CARTON	11/01/2024
1	NDC: 0941-0688-01	2500 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		11/01/2024

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: 0941-0692
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: 0941-0692-04	4 in 1 CARTON	11/01/2024
1	NDC: 0941-0692-01	2500 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		11/01/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare (Guangzhou) Co., Ltd		421040114	analysis(0941-0684, 0941-0688, 0941-0692) , label(0941-0684, 0941-0688, 0941-0692) , manufacture(0941-0684, 0941-0688, 0941-0692) , pack(0941-0684, 0941-0688, 0941-0692) , sterilize(0941-0684, 0941-0688, 0941-0692)