FDA Label for Dianeal Low Calcium With Dextrose
View Indications, Usage & Precautions
Dianeal Low Calcium With Dextrose Product Label
The following document was submitted to the FDA by the labeler of this product Vantive Us Healthcare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package/Label Principal Display Panel
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
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)
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
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)
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
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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