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FDA Drug information

DIANEAL LOW CALCIUM WITH DEXTROSE

Read time: 1 mins
Marketing start date: 12 Jan 2025

Summary of product characteristics


Effective Time

20241107

Version

2

Spl Product Data Elements

DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE 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 DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE 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 DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose WATER DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE 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

DIANEAL LOW CALCIUM WITH DEXTROSE

Generic Name

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

Product Ndc

0941-0727

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAPERITONEAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Lot Exp Baxter Logo FPB5215R 5000 ml DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Osmolarity 344 mOsmol/l Anhydrous Glucose C 6 H 12 O 6 13,6 g Sodium Chloride NaCl 5,38 g Na + mmol/l 132 Sodium Lactate C 3 H 5 NaO 3 4,48 g Ca ++ 1,25 Calcium Chloride CaCl 2 ·2H 2 O 0,184 g Mg ++ 0,25 Magnesium Chloride MgCl 2 ·6H 2 O 0,051 g Cl - 95 Water for Injections to 1000 ml C 3 H 5 O 3 - 40 Free from Bacterial Endotoxins For Intraperitoneal infusion Not for intravenous infusion Do not use unless the solution is clear and the container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Do not store above 25°C Do not refrigerate or freeze Keep out of the sight and reach of children UK: Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE UK POM symbol IE and MT: Baxter Holding B.V. Kobaltweg 49 354CE Utrecht Netherlands PA 2299/015/001 PL 00116/0230 MA 1277/01001 CB-35-04-610 FPB5215R 5000 ml x 2 Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Anhydrous Glucose 13,6 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g Water for Injections to 1000 ml Free from bacterial endotoxins. For intraperitoneal infusion. Not for intravenous use. For single use only. Do not use unless the solution is clear and the container undamaged. Once removed from the overpouch use immediately. Discard unused solution. 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, 354CE Utrecht, Netherlands PA 2299/015/001 PL 00116/0230 MA 1277/01001 Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-198 POM symbol Barcode (01)50085412574375(17)201200(10)88B88B88B8 Dianeal PD4 Glucose 1.36% w/v / 13,6mg/ml Lot: FPB5215R 5000 ml x 2 Lot Exp Baxter Logo FPB5225R 5000 ml DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml Solution for Peritoneal Dialysis Formula g/l Osmolarity 395 mOsmol/l Anhydrous Glucose C 6 H 12 O 6 22,7 g Sodium Chloride NaCl 5,38 g Na + mmol/l 132 Sodium Lactate C 3 H 5 NaO 3 4,48 g Ca ++ 1,25 Calcium Chloride CaCl 2 ·2H 2 O 0,184 g Mg ++ 0,25 Magnesium Chloride MgCl 2 ·6H 2 O 0,051 g Cl - 95 Water for Injections to 1000 ml C 3 H 5 O 3 - 40 Free from Bacterial Endotoxins For Intraperitoneal infusion Not for intravenous infusion Do not use unless the solution is clear and the container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Do not store above 25°C Do not refrigerate or freeze Keep out of the sight and reach of children UK: Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE UK POM symbol IE and MT: Baxter Holding B.V., Kobaltweg 49, 354CE, Utrecht, Netherlands PA 2299/015/002 PL 00116/0231 MA 1277/01002 CB-35-04-611 FPB5225R 5000 ml x 2 Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml Solution for Peritoneal Dialysis Formula g/l Anhydrous Glucose 22,7 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g Water for Injections to 1000 ml Free from bacterial endotoxins. For intraperitoneal infusion. Not for intravenous use. For single use only. Do not use unless the solution is clear and the container undamaged. Once removed from the overpouch use immediately. Discard unused solution. 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, 354CE Utrecht, Netherlands PA 2299/015/002 PL 00116/0231 MA 1277/01002 Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-199 POM symbol Barcode (01)50085412574382(17)201200(10)88B88B88B8 Dianeal PD4 Glucose 2.27% w/v / 22,7mg/ml Lot: FPB5225R 5000 ml x 2 Lot Exp Baxter Logo FPB5235R 5000 ml DIANEAL PD4 Glucose 3,86% w/v / 38,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Osmolarity 395 mOsmol/l Anhydrous Glucose C 6 H 12 O 6 38,6 g Sodium Chloride NaCl 5,38 g Na + mmol/l 132 Sodium Lactate C 3 H 5 NaO 3 4,48 g Ca ++ 1,25 Calcium Chloride CaCl 2 ·2H 2 O 0,184 g Mg ++ 0,25 Magnesium Chloride MgCl 2 ·6H 2 O 0,051 g Cl - 95 Water for Injections to 1000 ml C 3 H 5 O 3 - 40 Free from Bacterial Endotoxins For Intraperitoneal infusion Not for intravenous infusion Do not use unless the solution is clear and the container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Do not store above 25°C Do not refrigerate or freeze Keep out of the sight and reach of children UK: Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE UK POM symbol IE and MT: Baxter Holding B.V. Kobaltweg 49 354CE Utrecht Netherlands PA 2299/015/003 PL 00116/0232 MA 1277/01003 CB-35-04-612 FPB5235R 5000 ml x 2 Dianeal PD4 Glucose 3.86% w/v / 38,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Anhydrous Glucose 38,6 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g Water for Injections to 1000 ml Free from bacterial endotoxins. For intraperitoneal infusion. Not for intravenous use. For single use only. Do not use unless the solution is clear and the container undamaged. Once removed from the overpouch use immediately. Discard unused solution. 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, 354CE Utrecht, Netherlands PA 2299/015/003 PL 00116/0232 MA 1277/01003 Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-200 POM symbol Barcode (01)50085412574399(17)201200(10)88B88B88B8 Dianeal PD4 Glucose 3.86% w/v / 38,6mg/ml Lot: FPB5235R 5000 ml x 2 Lot Exp Vantive Logo FPB5215R 5000 ml DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Osmolarity 344 mOsmol/l Anhydrous Glucose C 6 H 12 O 6 13,6 g Sodium Chloride NaCl 5,38 g Na + mmol/l 132 Sodium Lactate C 3 H 5 NaO 3 4,48 g Ca ++ 1,25 Calcium Chloride CaCl 2 ·2H 2 O 0,184 g Mg ++ 0,25 Magnesium Chloride MgCl 2 ·6H 2 O 0,051 g Cl - 95 Water for Injections to 1000 ml C 3 H 5 O 3 - 40 Free from Bacterial Endotoxins For Intraperitoneal infusion Not for intravenous infusion Do not use unless the solution is clear and the container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Do not store above 25°C Do not refrigerate or freeze Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom POM symbol PL 58711/0002 CB-35-05-235 FPB5215R 5000 ml x 2 Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Anhydrous Glucose 13,6 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g Water for Injections to 1000 ml Free from bacterial endotoxins. For intraperitoneal infusion. Not for intravenous use. For single use only. Do not use unless the solution is clear and the container undamaged. Once removed from the overpouch use immediately. Discard unused solution. Keep out of the sight and reach of children. Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0002 Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-968 POM symbol Barcode (01)57332414202991(17)201200(10)88B88B88B8 Dianeal PD4 Glucose 1.36% w/v / 13,6mg/ml Lot: FPB5215R 5000 ml x 2 Lot Exp Vantive Logo FPB5225R 5000 ml DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml Solution for Peritoneal Dialysis Formula g/l Osmolarity 395 mOsmol/l Anhydrous Glucose C 6 H 12 O 6 22,7 g Sodium Chloride NaCl 5,38 g Na + mmol/l 132 Sodium Lactate C 3 H 5 NaO 3 4,48 g Ca ++ 1,25 Calcium Chloride CaCl 2 ·2H 2 O 0,184 g Mg ++ 0,25 Magnesium Chloride MgCl 2 ·6H 2 O 0,051 g Cl - 95 Water for Injections to 1000 ml C 3 H 5 O 3 - 40 Free from Bacterial Endotoxins For Intraperitoneal infusion Not for intravenous infusion Do not use unless the solution is clear and the container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Do not store above 25°C Do not refrigerate or freeze Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom POM symbol PL 58711/0003 CB-35-05-236 FPB5225R 5000 ml x 2 Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml Solution for Peritoneal Dialysis Formula g/l Anhydrous Glucose 22,7 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g Water for Injections to 1000 ml Free from bacterial endotoxins. For intraperitoneal infusion. Not for intravenous use. For single use only. Do not use unless the solution is clear and the container undamaged. Once removed from the overpouch use immediately. Discard unused solution. Keep out of the sight and reach of children. Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58744/0003 Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-969 POM symbol Barcode (01)57332414203073(17)201200(10)88B88B88B8 Dianeal PD4 Glucose 2.27% w/v / 22,7mg/ml Lot: FPB5225R 5000 ml x 2 Lot Exp Vantive Logo FPB5235R 5000 ml DIANEAL PD4 Glucose 3,86% w/v / 38,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Osmolarity 395 mOsmol/l Anhydrous Glucose C 6 H 12 O 6 38,6 g Sodium Chloride NaCl 5,38 g Na + mmol/l 132 Sodium Lactate C 3 H 5 NaO 3 4,48 g Ca ++ 1,25 Calcium Chloride CaCl 2 ·2H 2 O 0,184 g Mg ++ 0,25 Magnesium Chloride MgCl 2 ·6H 2 O 0,051 g Cl - 95 Water for Injections to 1000 ml C 3 H 5 O 3 - 40 Free from Bacterial Endotoxins For Intraperitoneal infusion Not for intravenous infusion Do not use unless the solution is clear and the container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Do not store above 25°C Do not refrigerate or freeze Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom POM symbol PL 58711/0004 CB-35-05-237 FPB5235R 5000 ml x 2 Dianeal PD4 Glucose 3.86% w/v / 38,6 mg/ml Solution for Peritoneal Dialysis Formula g/l Anhydrous Glucose 38,6 g Sodium Chloride 5,38 g Sodium Lactate 4,48 g Calcium Chloride 0,184 g Magnesium Chloride 0,051 g Water for Injections to 1000 ml Free from bacterial endotoxins. For intraperitoneal infusion. Not for intravenous use. For single use only. Do not use unless the solution is clear and the container undamaged. Once removed from the overpouch use immediately. Discard unused solution. Keep out of the sight and reach of children. Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0004 Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-970 POM symbol Barcode (01)57332414203004(17)201200(10)88B88B88B8 Dianeal PD4 Glucose 3.86% w/v / 38,6mg/ml Lot: FPB5235R 5000 ml x 2 Representative Dianeal Container Label.jpg Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label Representative Dianeal Container Label Representative Dianeal Carton Label

Package Label Principal Display Panel Table

Formula

g/l

Osmolarity

344 mOsmol/l

Anhydrous Glucose

C 6H 12O 6

13,6 g

Sodium Chloride

NaCl

5,38 g

Na +

mmol/l

132

Sodium Lactate

C 3H 5NaO 3

4,48 g

Ca ++

1,25

Calcium Chloride

CaCl 2·2H 2O

0,184 g

Mg ++

0,25

Magnesium Chloride

MgCl 2·6H 2O

0,051 g

Cl -

95

Water for Injections to 1000ml

C 3H 5O 3-

40

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