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"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-01",
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"DIANEAL LOW CALCIUM WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose 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 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"
],
"health_care_provider_letter": [
"Health Care Provider Letter Dianeal DHCP Letter 1 Dianeal DHCP Letter 2 Dianeal DHCP Letter 3 Dianeal DHCP Letter 4 Dianeal DHCP Letter 5 Dianeal DHCP Letter 6 Dianeal DHCP Letter 7 Dianeal DHCP Letter 8 Dianeal DHCP Letter 9 Dianeal DHCP Letter 10"
],
"package_label_principal_display_panel": [
"PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Lot Exp Baxter Logo FPB9718R 2500 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 mmol/l Sodium Chloride NaCl 5,38 g Na + 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 IE and MT: Baxter Holding B.V ., Kobaltweg 49, 3542CE, Utrecht, Netherlands POM Symbol PA 2299/015/001 PL 00116/0230 MA 1277/01001 CB-35-04-620 FPB9718R 2500 ml x 4 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, 3542CE Utrecht, Netherlands PA 2299/015/001 PL 00116/0230 MA 1277/01001 POM Symbol Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-208 Barcode (01)50085412574429(17)201200(10)88B88B88B8 Dianeal PD4 Glucose FPB9718R 1.36% w/v / 13,6 mg/ml 2500 ml x 4 Lot: Lot Exp Vantive Logo FPB9718R 2500 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 mmol/l Sodium Chloride NaCl 5,38 g Na + 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-35-05-245 FPB9718R 2500 ml x 4 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 POM Symbol Lot: UK Only Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-978 Barcode (01)57332414203561(17)201200(10)88B88B88B8 Dianeal PD4 Glucose FPB9718R 1.36% w/v / 13,6 mg/ml 2500 ml x 4 Lot: Lot Exp Baxter Logo FPB9728R 2500 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 mmol/l Sodium Chloride NaCl 5,38 g Na + 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 IE and MT: Baxter Holding B.V . Kobaltweg 49 3542CE Utrecht, Netherlands POM Symbol PA 2299/015/002 PL 00116/0231 MA 1277/01002 CB-35-04-621 FPB9728R 2500 ml x 4 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, 3542CE Utrecht, Netherlands PA 2299/015/002 PL 00116/0231 MA 1277/01002 POM Symbol Lot: Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-209 Barcode (01)50085412574436(17)201200(10)88B88B88B8 Dianeal PD4 Glucose FPB9728R 2.27% w/v / 22,7 mg/ml 2500 ml x 4 Lot: Lot Exp Vantive Logo FPB9728R 2500 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 mmol/l Sodium Chloride NaCl 5,38 g Na + 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-35-05-246 FPB9728R 2500 ml x 4 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 58711/0003 POM Symbol Lot: UK Only Single bag with Luer connector Do not store above 25°C. Do not refrigerate or freeze. 88-46-13-979 Barcode (01)5733241420885(17)201200(10)88B88B88B8 Dianeal PD4 Glucose FPB9728R 2.27% w/v / 22,7 mg/ml 2500 ml x 4 Lot: Dianeal Representative Container Label Dianeal Representative Carton Label Dianeal Representative Container Label Dianeal Representative Carton Label Dianeal Representative Container Label Dianeal Representative Carton Label Dianeal Representative Container Label Dianeal Representative Carton Label"
],
"package_label_principal_display_panel_table": [
"