DIANEAL LOW CALCIUM WITH DEXTROSE

Manufacturer
Vantive US Healthcare LLC | Vantive Manufacturing LImited
Effective date
2025-07-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:36:43

Label at a glance#

ProductDIANEAL LOW CALCIUM WITH DEXTROSE
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Provider Letter

HEALTH CARE PROVIDER LETTER SECTION

Dianeal DHCP Letter 1
Dianeal DHCP Letter 1
Dianeal DHCP Letter 2
Dianeal DHCP Letter 2
Dianeal DHCP Letter 3
Dianeal DHCP Letter 3
Dianeal DHCP Letter 4
Dianeal DHCP Letter 4
Dianeal DHCP Letter 5
Dianeal DHCP Letter 5
Dianeal DHCP Letter 6
Dianeal DHCP Letter 6
Dianeal DHCP Letter 7
Dianeal DHCP Letter 7
Dianeal DHCP Letter 8
Dianeal DHCP Letter 8
Dianeal DHCP Letter 9
Dianeal DHCP Letter 9
Dianeal DHCP Letter 10
Dianeal DHCP Letter 10
Dianeal DHCP Letter 11
Dianeal DHCP Letter 11
Dianeal DHCP Letter 12
Dianeal DHCP Letter 12

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative Dianeal Container Label.jpg
Representative Dianeal Container Label.jpg

Lot Exp
BaxterLogo FPB5215R 5000 ml
DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

344 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

13,6 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

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 children

UK:
Baxter Healthcare Ltd
Caxton Way Thetford Norfolk IP24 3SE UK

POM symbol

IE and MT:
Baxter Holding B.V.Kobaltweg 49 354CE Utrecht Netherlands

PA 2299/015/001
PL 00116/0230
MA 1277/01001

CB-35-04-610

Representative Dianeal Carton Label
Representative Dianeal Carton Label

FPB5215R 5000 ml x 2
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, 354CE Utrecht, Netherlands

PA 2299/015/001 PL 00116/0230 MA 1277/01001

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-198

POM symbol

Barcode
(01)50085412574375(17)201200(10)88B88B88B8

Dianeal PD4 Glucose
1.36% w/v / 13,6mg/ml

Lot:

FPB5215R
5000 ml x 2

Representative Dianeal Container Label
Representative Dianeal Container Label

Lot Exp
BaxterLogo FPB5225R 5000 ml
DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

395 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

22,7 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

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 children

UK:
Baxter Healthcare Ltd
Caxton Way Thetford Norfolk IP24 3SE UK

POM symbol

IE and MT:
Baxter Holding B.V.,Kobaltweg 49, 354CE, Utrecht, Netherlands

PA 2299/015/002
PL 00116/0231
MA 1277/01002

CB-35-04-611

Representative Dianeal Carton Label
Representative Dianeal Carton Label

FPB5225R 5000 ml x 2
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, 354CE Utrecht, Netherlands

PA 2299/015/002 PL 00116/0231 MA 1277/01002

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-199

POM symbol

Barcode
(01)50085412574382(17)201200(10)88B88B88B8

Dianeal PD4 Glucose
2.27% w/v / 22,7mg/ml

Lot:

FPB5225R
5000 ml x 2

Representative Dianeal Container Label
Representative Dianeal Container Label

Lot Exp
BaxterLogo FPB5235R 5000 ml
DIANEAL PD4 Glucose 3,86% w/v / 38,6 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

395 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

38,6 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

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 children

UK:
Baxter Healthcare Ltd
Caxton Way Thetford Norfolk IP24 3SE UK

POM symbol

IE and MT:
Baxter Holding B.V.Kobaltweg 49 354CE Utrecht Netherlands

PA 2299/015/003
PL 00116/0232
MA 1277/01003

CB-35-04-612

Representative Dianeal Carton Label
Representative Dianeal Carton Label

FPB5235R 5000 ml x 2
Dianeal PD4 Glucose 3.86% w/v / 38,6 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Anhydrous Glucose

38,6 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, 354CE Utrecht, Netherlands

PA 2299/015/003 PL 00116/0232 MA 1277/01003

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-200

POM symbol

Barcode
(01)50085412574399(17)201200(10)88B88B88B8

Dianeal PD4 Glucose
3.86% w/v / 38,6mg/ml

Lot:

FPB5235R
5000 ml x 2

Representative Dianeal Container Label
Representative Dianeal Container Label

Lot Exp
Vantive Logo FPB5215R 5000 ml
DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

344 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

13,6 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

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 children

Vantive Limited
Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

POM symbol

PL 58711/0002
CB-35-05-235

Representative Dianeal Carton Label
Representative Dianeal Carton Label

FPB5215R 5000 ml x 2
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

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-968

POM symbol

Barcode
(01)57332414202991(17)201200(10)88B88B88B8

Dianeal PD4 Glucose
1.36% w/v / 13,6mg/ml

Lot:

FPB5215R
5000 ml x 2

Representative Dianeal Container Label
Representative Dianeal Container Label

Lot Exp
Vantive Logo FPB5225R 5000 ml
DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

395 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

22,7 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

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 children

Vantive Limited
Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

POM symbol

PL 58711/0003

CB-35-05-236

Representative Dianeal Carton Label
Representative Dianeal Carton Label

FPB5225R 5000 ml x 2
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 58744/0003

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-969

POM symbol

Barcode
(01)57332414203073(17)201200(10)88B88B88B8

Dianeal PD4 Glucose
2.27% w/v / 22,7mg/ml

Lot:

FPB5225R
5000 ml x 2

Representative Dianeal Container Label
Representative Dianeal Container Label

Lot Exp
Vantive Logo FPB5235R 5000 ml
DIANEAL PD4 Glucose 3,86% w/v / 38,6 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

395 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

38,6 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

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 children

Vantive Limited
Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

POM symbol

PL 58711/0004

CB-35-05-237

Representative Dianeal Carton Label
Representative Dianeal Carton Label

FPB5235R 5000 ml x 2
Dianeal PD4 Glucose 3.86% w/v / 38,6 mg/ml
Solution for Peritoneal Dialysis

Formula

g/l

Anhydrous Glucose

38,6 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 58711/0004

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-970

POM symbol

Barcode
(01)57332414203004(17)201200(10)88B88B88B8

Dianeal PD4 Glucose
3.86% w/v / 38,6mg/ml

Lot:

FPB5235R
5000 ml x 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
800474calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5]SBD6
800115calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5]SBD6
800074calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25]SBD6
800472calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCD6
800111calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCD6
800066calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCD6
800472Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSY6
800474Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5]SY6
800111Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSY6
800115Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5]SY6
800066Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSY6
800074Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25]SY6
800474Dianeal Low Calcium 1.5 % Intraperitoneal SolutionSY6
800115Dianeal Low Calcium 2.5 % Intraperitoneal SolutionSY6
800074Dianeal Low Calcium 4.25 % Intraperitoneal SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LACTIC ACID, UNSPECIFIED FORM Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0941-0727-01DIANEAL LOW CALCIUM WITH DEXTROSE5000 mL in 1 BAGINJECTION, SOLUTION50006
0941-0727-02DIANEAL LOW CALCIUM WITH DEXTROSE2 in 1 CARTONINJECTION, SOLUTION26
0941-0729-01DIANEAL LOW CALCIUM WITH DEXTROSE5000 mL in 1 BAGINJECTION, SOLUTION50006
0941-0729-02DIANEAL LOW CALCIUM WITH DEXTROSE2 in 1 CARTONINJECTION, SOLUTION26
0941-0731-01DIANEAL LOW CALCIUM WITH DEXTROSE5000 mL in 1 BAGINJECTION, SOLUTION50006
0941-0731-02DIANEAL LOW CALCIUM WITH DEXTROSE2 in 1 CARTONINJECTION, SOLUTION26

Products#

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DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
ndc (package): 0941-0729-02
ndc (package): 0941-0731-01
ndc (package): 0941-0727-02
ndc (package): 0941-0729-01
ndc (package): 0941-0727-01
ndc (package): 0941-0731-02
ndc (product): 0941-0727
ndc (product): 0941-0729
ndc (product): 0941-0731
ndc11 (package): 00941073102
ndc11 (package): 00941072701
ndc11 (package): 00941072702
ndc11 (package): 00941073101
ndc11 (package): 00941072902
ndc11 (package): 00941072901
spl id: 38f8e8b2-1f8a-e0aa-e063-6294a90ad63f
spl set id: b79ef556-37b3-4fd0-8589-c633033be9df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.