FDA Label for Extraneal

View Indications, Usage & Precautions

Extraneal Product Label

The following document was submitted to the FDA by the labeler of this product Vantive Us Healthcare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package/Label Principal Display Panel



Lot EXP
B5268 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-35-04-608

EXTRANEAL
FPB5268C
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

88-46-13-196

Lot: EXP

Do not store below 4°C

Twin bag with Luer connector

MA 1277/01101
PA 2299/017/001
PL 00116/0266

POM Symbol

Barcode
(01)554 13760423833(17)201200(10)88C88C88B2

EXTRANEAL
FPB5268C
2000 ml x 5

Lot: EXP

Lot EXP
B5268 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-35-05-250

EXTRANEAL
FPB5268C
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

88-46-14-007

Lot: EXP

UK Only

Do not store below 4°C

Twin bag with Luer connector

PL 58711/0005

POM Symbol

Barcode
(01)57332414203103 (17)201200(10)88C88C88B2

EXTRANEAL
FPB5268C
2000 ml x 5

Lot: EXP

Lot EXP
B5270 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-35-04-609

EXTRANEAL
FPB5270
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

88-46-13-197

Lot: EXP

Do not store below 4°C

Twin bag with Luer connector

MA 1277/01101
PA 2299/017/001
PL 00116/0266

POM Symbol

Barcode
(01)50085412574412(17)201200(10)88C88C88B2

EXTRANEAL
FPB5270
2000 ml x 4

Lot: EXP

Lot EXP
B5270 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-35-05-251

EXTRANEAL
FPB5270
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

88-46-14-008

Lot: EXP

UK Only

Do not store below 4°C

Twin bag with Luer connector

PL 58711/0005

POM Symbol

Barcode
(01)57332414202649 (17)201200(10)88C88C88B2

EXTRANEAL
FPB5270

2500 ml x 4

Lot: EXP


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