EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

EXTRANEAL by

Drug Labeling and Warnings

EXTRANEAL by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Healthcare S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EXTRANEAL 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0681
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G)	ICODEXTRIN	7.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	540 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	SODIUM LACTATE	450 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.1 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0681-08	4 in 1 CARTON	10/21/2024
1	NDC: 0941-0681-02	2500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/21/2024

EXTRANEAL 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0719
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G)	ICODEXTRIN	7.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	540 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	SODIUM LACTATE	450 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.1 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0719-05	5 in 1 CARTON	10/21/2024
1	NDC: 0941-0719-01	2000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/21/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare S.A.		988899845	analysis(0941-0681, 0941-0719) , api manufacture(0941-0681, 0941-0719) , label(0941-0681, 0941-0719) , manufacture(0941-0681, 0941-0719) , pack(0941-0681, 0941-0719) , sterilize(0941-0681, 0941-0719)