Dianeal Low Calcium With Dextrose Injection, Solution
FDA Label NDC 0941-0690

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vantive Us Healthcare Llc for the product Dianeal Low Calcium With Dextrose (NDC 0941-0690). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Representative Dianeal Container Label (Image 09)

Representative Dianeal Container Label (Image 09)

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 (Image 10)

Representative Dianeal Carton Label (Image 10)

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 (Image 11)

Representative Dianeal Container Label (Image 11)

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 (Image 12)

Representative Dianeal Carton Label (Image 12)

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 (Image 13)

Representative Dianeal Container Label (Image 13)

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 (Image 14)

Representative Dianeal Carton Label (Image 14)

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

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