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  • EXTRANEAL CALCIUM CHLORIDE 25.7 mg/100mL Baxter Healthcare Corporation
FDA Drug information

EXTRANEAL

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20241107

Version

2

Spl Product Data Elements

EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION

Brand Name

EXTRANEAL

Generic Name

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Product Ndc

0941-0717

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

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 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/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 2 0 0,257 g Magnesium Chloride 6H 2 0 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 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/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 2 0 0,257 g Magnesium Chloride 6H 2 0 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 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/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 2 0 0,257 g Magnesium Chloride 6H 2 0 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 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/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 2 0 0,257 g Magnesium Chloride 6H 2 0 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 Representative Extraneal Container Label -FPB5268C.jpg Representative Extraneal Carton Label - FPB5268C Vantive Representative Extraneal Container Label - FPB5268C Vantive Representative Extraneal Carton Label - FPB5268C Representative Extraneal Container Label - FPB5270 Representative Extraneal Carton Label - FPB5270 Vantive Representative Extraneal Container Label - FPB5270 Vantive Representative Extraneal Carton Label - FPB5270

Package Label Principal Display Panel Table

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

Drug section

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