Dianeal Low Calcium Peritoneal Dialysis Solution: Package Insert / Prescribing Info

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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

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

FPB5215R 5000 ml x 2
Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis

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

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

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

FPB5225R 5000 ml x 2
Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis

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

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

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

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

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

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

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

FPB5215R 5000 ml x 2
Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml
Solution for Peritoneal Dialysis

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

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

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

FPB5225R 5000 ml x 2
Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml
Solution for Peritoneal Dialysis

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

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

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

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

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