Extraneal Injection, Solution
FDA Label NDC 0941-0719

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 Extraneal (NDC 0941-0719). 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.

Package/Label Principal Display Panel

Representative Extraneal Container Label (Image 10)

Representative Extraneal Container Label (Image 10)

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

Representative Extraneal Carton Label (Image 11)

Representative Extraneal Carton Label (Image 11)

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

Vantive Representative Extraneal Container Label (Image 12)

Vantive Representative Extraneal Container Label (Image 12)

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

Vantive Representative Extraneal Carton Label (Image 13)

Vantive Representative Extraneal Carton Label (Image 13)

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

Representative Extraneal Container Label (Image 14)

Representative Extraneal Container Label (Image 14)

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

Representative Extraneal Carton Label (Image 15)

Representative Extraneal Carton Label (Image 15)

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

Vantive Representative Extraneal Container Label (Image 16)

Vantive Representative Extraneal Container Label (Image 16)

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

Vantive Representative Extraneal Carton Label (Image 17)

Vantive Representative Extraneal Carton Label (Image 17)

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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