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

----------

DIANEAL Low Calcium with Dextrose

Health Care Provider Letter

Dianeal DHCP Letter 1
Dianeal DHCP Letter 2
Dianeal DHCP Letter 3
Dianeal DHCP Letter 4
Dianeal DHCP Letter 5
Dianeal DHCP Letter 6
Dianeal DHCP Letter 7
Dianeal DHCP Letter 8

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Representative Dianeal Container Label

Manufacturing Date

Lot Number

EXP

6AB9766 2L (APPROX 80ml EXCESS)
BaxterLogo Dianeal PD-4 Ultrabag
Low Calcium Peritoneal Dialysis Solution (Lactate-G1.5%)
[Strengths]Containing 1.5% glucose
[Ingredients](Each 100 ml contains) Ionic concentration(mmol/L)

Dextrose Hydrous

1.5 g

Sodium

132

Sodium Chloride

538mg

Calcium

1.24

Calcium Chloride

18.3mg

Magnesium

0.25

Magnesium Chloride

5.1mg

Chloride

95

Sodium Lactate

448mg

Lactate

40

[Characters]This product is a sterile, Nonpyrogen, Colorless
or slightly yellow, Clear solution, pH 5.2 (4.5 to 6.5)

Calculated osmolarity(theoretical value) 344 mOsmol/L

[Indications]Low-calcium peritoneal dialysis solutions are
indicated for use in acute and chronic renal failure patients
being maintained on continuous ambulatory peritoneal dialysis
when nondialytic medical therapy is judged to be inadequate

[Usage and Dosage] [Adverse Reactions]
[Contraindications]
See instructions for details

[Precautions]After removing the outer bag, squeeze the
dialysis bag with uniform force to check for leakage,
If leakage is found, stop using the solution;
This product should be used once;
For other details, please refer to the instructions

[Storage]Keep sealed
[Approval License Number]GYZZ H20023569
[Approval License Holder]BAXTER
HEALTHCARE(GUANGZHOU) Co., Ltd

[Legal Address]Jiaoyuan Road, Dongji industrial District,
GETDD, Guangzhou, P.R. China

[Manufacturer]BAXTER HEALTHCARE(GUANGZHOU) Co., Ltd
[Manufacturing Address]Jiaoyuan Road, Dongji industrial
District GETDD,Guangzhou, P.R. China

CONTAINER PL-146
Baxter, Dianeal, Ultrabag are registered trademarks of BAXTER INTERNATIONAL INC. in China

Representative Dianeal Carton Label

Low Calcium Peritoneal Dialysis Solution (Lactate-G1.5%)

[Specification] Contain 1.5% Dextrose 6AB9766

Lot G00000000 2LX 8 Bags

Manu. Date 0000-00-00 PD-4 UltraBag

Valid in 0000-00

Barcode
6 9 3 7 7 6 5 3 0 0 2 3 3 >

S/N 0000

Representative Dianeal Container Label

Manufacturing Date

Lot Number

EXP

6AB9776 2L (APPROX 80ml EXCESS)
BaxterLogo Dianeal PD-4 Ultrabag
Low Calcium Peritoneal Dialysis Solution (Lactate-G2.5%)
[Strengths]Containing 2.5% glucose
[Ingredients](Each 100 ml contains) Ionic concentration(mmol/L)

Dextrose Hydrous

2.5 g

Sodium

132

Sodium Chloride

538mg

Calcium

1.24

Calcium Chloride

18.3mg

Magnesium

0.25

Magnesium Chloride

5.1mg

Chloride

95

Sodium Lactate

448mg

Lactate

40

[Characters]This product is a sterile, Nonpyrogen, Colorless
or slightly yellow, Clear solution, pH 5.2 (4.5 to 6.5)

Calculated osmolarity(theoretical value) 395 mOsmol/L

[Indications]Low-calcium peritoneal dialysis solutions are
indicated for use in acute and chronic renal failure patients
being maintained on continuous ambulatory peritoneal dialysis
when nondialytic medical therapy is judged to be inadequate

[Usage and Dosage] [Adverse Reactions]
[Contraindications]
See instructions for details

[Precautions]After removing the outer bag, squeeze the
dialysis bag with uniform force to check for leakage,
If leakage is found, stop using the solution;
This product should be used once;
For other details, please refer to the instructions

[Storage]Keep sealed
[Approval License Number]GYZZ H20023567
[Approval License Holder]BAXTER
HEALTHCARE(GUANGZHOU) Co., Ltd

[Legal Address]Jiaoyuan Road, Dongji industrial District,
GETDD, Guangzhou, P.R. China

[Manufacturer]BAXTER HEALTHCARE(GUANGZHOU) Co., Ltd
[Manufacturing Address]Jiaoyuan Road, Dongji industrial
District GETDD,Guangzhou, P.R. China

CONTAINER PL-146
Baxter, Dianeal, Ultrabag are registered trademarks of BAXTER INTERNATIONAL INC. in China

Representative Dianeal Carton Label

Low Calcium Peritoneal Dialysis Solution (Lactate-G2.5%)

[Specification] Contain 1.5% Dextrose 6AB9776

Lot G00000000 2LX 8 Bags

Manu. Date 0000-00-00 PD-4 UltraBag

Valid in 0000-00

Barcode
6 9 3 7 7 6 5 3 0 0 2 4 0 >

S/N 0000

Representative Dianeal Container Label

Manufacturing Date

Lot Number

EXP

6AB9796 2L (APPROX 80ml EXCESS)
BaxterLogo Dianeal PD-4 Ultrabag
Low Calcium Peritoneal Dialysis Solution (Lactate-G4.25%)
[Strengths]Containing 4.25% glucose
[Ingredients](Each 100 ml contains) Ionic concentration(mmol/L)

Dextrose Hydrous

4.25 g

Sodium

132

Sodium Chloride

538mg

Calcium

1.24

Calcium Chloride

18.3mg

Magnesium

0.25

Magnesium Chloride

5.1mg

Chloride

95

Sodium Lactate

448mg

Lactate

40

[Characters]This product is a sterile, Nonpyrogen, Colorless
or slightly yellow, Clear solution, pH 5.2 (4.5 to 6.5)

Calculated osmolarity(theoretical value) 483 mOsmol/L

[Indications]Low-calcium peritoneal dialysis solutions are
indicated for use in acute and chronic renal failure patients
being maintained on continuous ambulatory peritoneal dialysis
when nondialytic medical therapy is judged to be inadequate

[Usage and Dosage] [Adverse Reactions]
[Contraindications]
See instructions for details

[Precautions]After removing the outer bag, squeeze the
dialysis bag with uniform force to check for leakage,
If leakage is found, stop using the solution;
This product should be used once;
For other details, please refer to the instructions

[Storage]Keep sealed
[Approval License Number]GYZZ H20023568
[Approval License Holder]BAXTER
HEALTHCARE(GUANGZHOU) Co., Ltd

[Legal Address]Jiaoyuan Road, Dongji industrial District,
GETDD, Guangzhou, P.R. China

[Manufacturer]BAXTER HEALTHCARE(GUANGZHOU) Co., Ltd
[Manufacturing Address]Jiaoyuan Road, Dongji industrial
District GETDD,Guangzhou, P.R. China

CONTAINER PL-146
Baxter, Dianeal, Ultrabag are registered trademarks of BAXTER INTERNATIONAL INC. in China

Representative Dianeal Carton Label

Low Calcium Peritoneal Dialysis Solution (Lactate-G4.25%)

[Specification] Contain 1.5% Dextrose 6AB9796

Lot G00000000 2LX 8 Bags

Manu. Date 0000-00-00 PD-4 UltraBag

Valid in 0000-00

Barcode
6 9 3 7 7 6 5 3 0 0 2 5 7 >

S/N 0000

DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0686
Route of AdministrationINTRAPERITONEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0941-0686-088 in 1 CARTON11/01/202411/30/2026
1NDC:0941-0686-012000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage11/01/202411/30/2026
DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0690
Route of AdministrationINTRAPERITONEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0941-0690-088 in 1 CARTON11/01/202409/30/2026
1NDC:0941-0690-012000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage11/01/202409/30/2026
DIANEAL LOW CALCIUM WITH DEXTROSE 
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0694
Route of AdministrationINTRAPERITONEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0941-0694-088 in 1 CARTON11/01/202409/30/2026
1NDC:0941-0694-012000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage11/01/202409/30/2026
Labeler - Vantive US Healthcare LLC (119181963)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare (Guangzhou) Co., Ltd421040114manufacture(0941-0686, 0941-0690, 0941-0694) , analysis(0941-0686, 0941-0690, 0941-0694) , label(0941-0686, 0941-0690, 0941-0694) , pack(0941-0686, 0941-0690, 0941-0694) , sterilize(0941-0686, 0941-0690, 0941-0694)

Revised: 5/2025
Document Id: 34be97f0-8259-2735-e063-6394a90ad5fe
Set id: 0fb30b7e-8e1b-49c7-afac-2d5c01b9ff45
Version: 4
Effective Time: 20250509
 
Vantive US Healthcare LLC