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FDA Drug information

DIANEAL LOW CALCIUM WITH DEXTROSE

Read time: 1 mins
Marketing start date: 12 Jan 2025
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Summary of product characteristics


Effective Time

20241107

Version

2

Spl Product Data Elements

DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION

Brand Name

DIANEAL LOW CALCIUM WITH DEXTROSE

Generic Name

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

Product Ndc

0941-0686

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Manufacturing Date Lot Number EXP 6AB9766 2L (APPROX 80ml EXCESS) Baxter Logo 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 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 Manufacturing Date Lot Number EXP 6AB9776 2L (APPROX 80ml EXCESS) Baxter Logo 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 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 Manufacturing Date Lot Number EXP 6AB9796 2L (APPROX 80ml EXCESS) Baxter Logo 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 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 Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label

Package Label Principal Display Panel Table

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

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