Dianeal Low Calcium With Dextrose Injection, Solution
FDA Label NDC 0941-0733

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 0941-0733). 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.

Label Section Quick Index

Package/Label Principal Display Panel

Dianeal Representative Container Label (Image 11)

Dianeal Representative Container Label (Image 11)

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 children

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

IE and MT:
Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands

POM Symbol

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

CB-35-04-620

Dianeal Representative Carton Label (Image 12)

Dianeal Representative Carton Label (Image 12)

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 connector

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

88-46-13-208

Barcode
(01)50085412574429(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9718R

1.36% w/v / 13,6 mg/ml 2500 ml x 4

Lot:

Dianeal Representative Container Label (Image 13)

Dianeal Representative Container Label (Image 13)

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 children

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

POM Symbol

PL 58711/0002

CB-35-05-245

Dianeal Representative Carton Label (Image 14)

Dianeal Representative Carton Label (Image 14)

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 connector

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

88-46-13-978

Barcode
(01)57332414203561(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9718R

1.36% w/v / 13,6 mg/ml 2500 ml x 4

Lot:

Dianeal Representative Container Label (Image 15)

Dianeal Representative Container Label (Image 15)

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 children

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

IE and MT:
Baxter Holding B.V. Kobaltweg 49 3542CE Utrecht, Netherlands

POM Symbol

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

CB-35-04-621

Dianeal Representative Carton Label (Image 16)

Dianeal Representative Carton Label (Image 16)

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 connector

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

88-46-13-209

Barcode
(01)50085412574436(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9728R

2.27% w/v / 22,7 mg/ml 2500 ml x 4

Lot:

Dianeal Representative Container Label (Image 17)

Dianeal Representative Container Label (Image 17)

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 children

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

POM Symbol

PL 58711/0003

CB-35-05-246

Dianeal Representative Carton Label (Image 18)

Dianeal Representative Carton Label (Image 18)

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 connector

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

88-46-13-979

Barcode
(01)5733241420885(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9728R

2.27% w/v / 22,7 mg/ml 2500 ml x 4

Lot:

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