Extraneal: Package Insert / Prescribing Info
Package insert / product label
Generic name: icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Dosage form: injection, solution
Drug class: Intravenous nutritional products
Medically reviewed by Drugs.com. Last updated on Nov 15, 2024.
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
EXTRANEAL
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution |
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EXTRANEAL
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution |
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Labeler - Baxter Healthcare Corporation (005083209) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Baxter Healthcare S.A. | 988899845 | analysis(0941-0681, 0941-0717) , api manufacture(0941-0681, 0941-0717) , label(0941-0681, 0941-0717) , manufacture(0941-0681, 0941-0717) , pack(0941-0681, 0941-0717) , sterilize(0941-0681, 0941-0717) |
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