Extraneal Solution For Peritoneal Dialysis

Extraneal Solution For Peritoneal Dialysis
SPL v6
SPL
SPL Set ID 2b327b13-a0e9-4b2c-9875-4470998e2e30
Route
INTRAPERITONEAL
Published
Effective Date 2024-10-21
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Icodextrin (7.5 g) Chloride Ion (540 mg) Lactic Acid, Unspecified Form (450 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Completed Since 2024-10-21 Until 2026-08-31
Description

Lot EXP B4938R 2000 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion 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 88-46-13-193 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)55413760441875(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4938R 2000 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-248 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-004 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414202786(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4945R 2500 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion 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 88-46-13-194 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)50085412574368(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP Lot EXP B4945R 2500 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-249 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-005 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414203240(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP

Medication Information

Description

Lot EXP B4938R 2000 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion 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 88-46-13-193 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)55413760441875(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4938R 2000 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-248 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-004 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414202786(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4945R 2500 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion 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 88-46-13-194 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)50085412574368(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP Lot EXP B4945R 2500 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-249 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-005 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414203240(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP

Health Care Provider Letter
Package/label Principal Display Panel

Lot EXP

B4938R 2000 ml

Baxter

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

UK:

Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE,

United Kingdom

IE and MT:

Baxter Holding B.V.,

Kobaltweg 49, 3542CE,

Utrecht, Netherlands

PL 00116/0266

PA 2299/017/001

MA 1277/01101

POM Symbol

Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605

EXTRANEAL

FPB4938RC

2000 ml x 5

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

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

88-46-13-193

Lot: EXP

Do not store below 4°C

Single bag with Luer connector

MA 1277/01101

PA 2299/017/001

PL 00116/0266

POM Symbol

Barcode

(01)55413760441875(17)201200(10)88C88C88B2

EXTRANEAL

FPB4938RC

2000 ml x 5

Lot: EXP

Lot EXP

B4938R 2000 ml

Vantive

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

Vantive Limited

Wavertree Technology Park

2 Wavertree Boulevard

Liverpool, L7 9PE

United Kingdom

PL 58711/0005

POM Symbol

CB-35-05-248

EXTRANEAL

FPB4938RC

2000 ml x 5

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

Keep out of the sight and reach of children

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

88-46-14-004

Lot: EXP

UK Only

Do not store below 4°C

Single bag with Luer connector

PL 58711/0005

POM Symbol

Barcode

(01)57332414202786(17)201200(10)88C88C88B2

EXTRANEAL

FPB4938RC

2000 ml x 5

Lot: EXP

Lot EXP

B4945R 2500 ml

Baxter

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

UK:

Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE,

United Kingdom

IE and MT:

Baxter Holding B.V.,

Kobaltweg 49, 3542CE, Utrecht,

Netherlands

PL 00116/0266

PA 2299/017/001

MA 1277/01101

POM Symbol

Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606

EXTRANEAL

FPB4945R

2500 ml x 4

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

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

88-46-13-194

Lot: EXP

Do not store below 4°C

Single bag with Luer connector

MA 1277/01101

PA 2299/017/001

PL 00116/0266

POM Symbol

Barcode

(01)50085412574368(17)201200(10)88C88C88B2

EXTRANEAL

FPB4945R

2500 ml x 4

Lot: EXP

Lot EXP

B4945R 2500 ml

Vantive

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

Vantive Limited

Wavertree Technology Park

2 Wavertree Boulevard

Liverpool, L7 9PE

United Kingdom

PL 58711/0005

POM Symbol

CB-35-05-249

EXTRANEAL

FPB4945R

2500 ml x 4

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

Keep out of the sight and reach of children

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

88-46-14-005

Lot: EXP

UK Only

Do not store below 4°C

Single bag with Luer connector

PL 58711/0005

POM Symbol

Barcode

(01)57332414203240(17)201200(10)88C88C88B2

EXTRANEAL

FPB4945R

2500 ml x 4

Lot: EXP

Structured Label Content

Health Care Provider Letter
Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

Lot EXP

B4938R 2000 ml

Baxter

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

UK:

Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE,

United Kingdom

IE and MT:

Baxter Holding B.V.,

Kobaltweg 49, 3542CE,

Utrecht, Netherlands

PL 00116/0266

PA 2299/017/001

MA 1277/01101

POM Symbol

Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605

EXTRANEAL

FPB4938RC

2000 ml x 5

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

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

88-46-13-193

Lot: EXP

Do not store below 4°C

Single bag with Luer connector

MA 1277/01101

PA 2299/017/001

PL 00116/0266

POM Symbol

Barcode

(01)55413760441875(17)201200(10)88C88C88B2

EXTRANEAL

FPB4938RC

2000 ml x 5

Lot: EXP

Lot EXP

B4938R 2000 ml

Vantive

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

Vantive Limited

Wavertree Technology Park

2 Wavertree Boulevard

Liverpool, L7 9PE

United Kingdom

PL 58711/0005

POM Symbol

CB-35-05-248

EXTRANEAL

FPB4938RC

2000 ml x 5

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

Keep out of the sight and reach of children

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

88-46-14-004

Lot: EXP

UK Only

Do not store below 4°C

Single bag with Luer connector

PL 58711/0005

POM Symbol

Barcode

(01)57332414202786(17)201200(10)88C88C88B2

EXTRANEAL

FPB4938RC

2000 ml x 5

Lot: EXP

Lot EXP

B4945R 2500 ml

Baxter

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

UK:

Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE,

United Kingdom

IE and MT:

Baxter Holding B.V.,

Kobaltweg 49, 3542CE, Utrecht,

Netherlands

PL 00116/0266

PA 2299/017/001

MA 1277/01101

POM Symbol

Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606

EXTRANEAL

FPB4945R

2500 ml x 4

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

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

88-46-13-194

Lot: EXP

Do not store below 4°C

Single bag with Luer connector

MA 1277/01101

PA 2299/017/001

PL 00116/0266

POM Symbol

Barcode

(01)50085412574368(17)201200(10)88C88C88B2

EXTRANEAL

FPB4945R

2500 ml x 4

Lot: EXP

Lot EXP

B4945R 2500 ml

Vantive

EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use

Not for intravenous use

Use as directed by a physician

Read the package leaflet before use

Keep out of the sight and reach of children

Nonpyrogenic

Do not store below 4°C

Do not use unless solution is clear and container undamaged

For single use only

Once removed from the overpouch use immediately

Discard unused solution

Vantive Limited

Wavertree Technology Park

2 Wavertree Boulevard

Liverpool, L7 9PE

United Kingdom

PL 58711/0005

POM Symbol

CB-35-05-249

EXTRANEAL

FPB4945R

2500 ml x 4

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use

Not for intravenous infusion

Keep out of the sight and reach of children

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

88-46-14-005

Lot: EXP

UK Only

Do not store below 4°C

Single bag with Luer connector

PL 58711/0005

POM Symbol

Barcode

(01)57332414203240(17)201200(10)88C88C88B2

EXTRANEAL

FPB4945R

2500 ml x 4

Lot: EXP

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Source: dailymed · Ingested: 2026-02-15T11:47:02.094826 · Updated: 2026-03-14T22:26:10.810615