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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