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 S.A.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Health Care Provider Letter
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Lot Exp
BaxterLogo FPB9718R 2500 ml
DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Osmolarity
344mOsmol/l
Anhydrous Glucose
C 6H 12O 6
13,6 g
mmol/l
Sodium Chloride
NaCl
5,38 g
Na +
- 132
Sodium Lactate
C 3H 5NaO 3
4,48 g
Ca ++
1,25
Calcium Chloride
CaCl 2·2H 2O
0,184 g
Mg ++
0,25
Magnesium Chloride
MgCl 2·6H 2O
0,051 g
Cl -
95
Water for Injections to 1000ml
C 3H 5O 3-
40
Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of childrenUK:
Baxter Healthcare Ltd
Caxton Way Thetford Norfolk
IP24 3SE UKIE and MT:
Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, NetherlandsPOM Symbol
PA 2299/015/001
PL 00116/0230
MA 1277/01001CB-35-04-620
FPB9718R 2500 ml x 4
Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Anhydrous Glucose
13,6 g
Sodium Chloride
5,38 g
Sodium Lactate
4,48 g
Calcium Chloride
0,184 g
Magnesium Chloride
0,051 g
Water for Injections to 1000 ml
Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. Keep out of the sight and reach of children.UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
PA 2299/015/001 PL 00116/0230 MA 1277/01001
POM Symbol
Lot:
Single bag with
Luer connectorDo not store above 25°C.
Do not refrigerate or
freeze.88-46-13-208
Barcode
(01)50085412574429(17)201200(10)88B88B88B8Dianeal PD4 Glucose FPB9718R
1.36% w/v / 13,6 mg/ml 2500 ml x 4
Lot:
Lot Exp
Vantive Logo FPB9718R 2500 ml
DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Osmolarity
344mOsmol/l
Anhydrous Glucose
C 6H 12O 6
13,6 g
mmol/l
Sodium Chloride
NaCl
5,38 g
Na +
- 132
Sodium Lactate
C 3H 5NaO 3
4,48 g
Ca ++
1,25
Calcium Chloride
CaCl 2·2H 2O
0,184 g
Mg ++
0,25
Magnesium Chloride
MgCl 2·6H 2O
0,051 g
Cl -
95
Water for Injections to 1000ml
C 3H 5O 3-
40
Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of childrenVantive Limited
Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United KingdomPOM Symbol
PL 58711/0002
CB-35-05-245
FPB9718R 2500 ml x 4
Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Anhydrous Glucose
13,6 g
Sodium Chloride
5,38 g
Sodium Lactate
4,48 g
Calcium Chloride
0,184 g
Magnesium Chloride
0,051 g
Water for Injections to 1000 ml
Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. Keep out of the sight and reach of children.Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom
PL 58711/0002
POM Symbol
Lot:
UK Only
Single bag with
Luer connectorDo not store above 25°C.
Do not refrigerate or
freeze.88-46-13-978
Barcode
(01)57332414203561(17)201200(10)88B88B88B8Dianeal PD4 Glucose FPB9718R
1.36% w/v / 13,6 mg/ml 2500 ml x 4
Lot:
Lot Exp
BaxterLogo FPB9728R 2500 ml
DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Osmolarity
395mOsmol/l
Anhydrous Glucose
C 6H 12O 6
22,7 g
mmol/l
Sodium Chloride
NaCl
5,38 g
Na +
- 132
Sodium Lactate
C 3H 5NaO 3
4,48 g
Ca ++
1,25
Calcium Chloride
CaCl 2·2H 2O
0,184 g
Mg ++
0,25
Magnesium Chloride
MgCl 2·6H 2O
0,051 g
Cl -
95
Water for Injections to 1000ml
C 3H 5O 3-
40
Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of childrenUK:
Baxter Healthcare Ltd
Caxton Way Thetford Norfolk IP24 3SE UKIE and MT:
Baxter Holding B.V. Kobaltweg 49 3542CE Utrecht, NetherlandsPOM Symbol
PA 2299/015/002
PL 00116/0231
MA 1277/01002CB-35-04-621
FPB9728R 2500 ml x 4
Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Anhydrous Glucose
22,7 g
Sodium Chloride
5,38 g
Sodium Lactate
4,48 g
Calcium Chloride
0,184 g
Magnesium Chloride
0,051 g
Water for Injections to 1000 ml
Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. Keep out of the sight and reach of children.UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
PA 2299/015/002 PL 00116/0231 MA 1277/01002
POM Symbol
Lot:
Single bag with
Luer connectorDo not store above 25°C.
Do not refrigerate or
freeze.88-46-13-209
Barcode
(01)50085412574436(17)201200(10)88B88B88B8Dianeal PD4 Glucose FPB9728R
2.27% w/v / 22,7 mg/ml 2500 ml x 4
Lot:
Lot Exp
Vantive Logo FPB9728R 2500 ml
DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Osmolarity
395mOsmol/l
Anhydrous Glucose
C 6H 12O 6
22,7 g
mmol/l
Sodium Chloride
NaCl
5,38 g
Na +
- 132
Sodium Lactate
C 3H 5NaO 3
4,48 g
Ca ++
1,25
Calcium Chloride
CaCl 2·2H 2O
0,184 g
Mg ++
0,25
Magnesium Chloride
MgCl 2·6H 2O
0,051 g
Cl -
95
Water for Injections to 1000ml
C 3H 5O 3-
40
Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of childrenVantive Limited
Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United KingdomPOM Symbol
PL 58711/0003
CB-35-05-246
FPB9728R 2500 ml x 4
Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis
Formula
g/l
Anhydrous Glucose
22,7 g
Sodium Chloride
5,38 g
Sodium Lactate
4,48 g
Calcium Chloride
0,184 g
Magnesium Chloride
0,051 g
Water for Injections to 1000 ml
Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. Keep out of the sight and reach of children.Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom
PL 58711/0003
POM Symbol
Lot:
UK Only
Single bag with
Luer connectorDo not store above 25°C.
Do not refrigerate or
freeze.88-46-13-979
Barcode
(01)5733241420885(17)201200(10)88B88B88B8Dianeal PD4 Glucose FPB9728R
2.27% w/v / 22,7 mg/ml 2500 ml x 4
Lot:
-
INGREDIENTS AND APPEARANCE
DIANEAL LOW CALCIUM WITH DEXTROSE
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0941-0733 Route of Administration INTRAPERITONEAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.36 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 18.4 mg in 100 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 5.1 mg in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0941-0733-04 4 in 1 CARTON 11/06/2024 1 NDC: 0941-0733-01 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 11/06/2024 DIANEAL LOW CALCIUM WITH DEXTROSE
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0941-0735 Route of Administration INTRAPERITONEAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 2.27 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 18.4 mg in 100 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 5.1 mg in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0941-0735-04 4 in 1 CARTON 11/06/2024 1 NDC: 0941-0735-01 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 11/06/2024 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Business Operations Baxter Healthcare S.A. 988899845 analysis(0941-0733, 0941-0735) , label(0941-0733, 0941-0735) , manufacture(0941-0733, 0941-0735) , pack(0941-0733, 0941-0735) , sterilize(0941-0733, 0941-0735)
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