DIANEAL LOW CALCIUM WITH DEXTROSE

20241107

2

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

DIANEAL LOW CALCIUM WITH DEXTROSE

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

0941-0713

HUMAN PRESCRIPTION DRUG

INTRAPERITONEAL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baxter Logo THB9766 2000 ml Dianeal® PD-4 Low Calcium with 1.5% Dextrose EACH 100ml CONTAINS 1.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 to 6.5) mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY 344 mOsmol/L(CALC) STERILE NON PYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSERT FOR FULL INFORMATION FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION KEEP OUT OF REACH OF CHILDREN AVOID EXCESSIVE HEAT SEE INSERT INDICATED FOR CHRONIC RENAL FAILURE PATIENTS BEING MAINTAINED ON PERITONEAL DIALYSIS DIRECTION TO BE USED AS DIRECTED BY THE PHYSICIAN STORAGE BELOW 30°C REG NO. 2A 12/59 THRS1107 BH Symbol MANUFACTURED BY: BAXTER MANUFACTURING (THAILAND) CO. LTD. RAYONG, THAILAND PD-4 1.5% Dianeal PD-4 Low Calcium with 1.5% Dextrose THB9766 6 X 2000 mL Each 100 ml contains Dextrose Hydrous USP 1.5 g Sodium Chloride USP 538 mg Sodium Lactate 448 mg Calcium Chloride USP 18.3 mg Magnesium Chloride USP 5.08 mg pH 5.2 (4.0-6.5) Reg No. 2A 12/59 Manufacturing by Baxter Manufacturing (Thailand) Co., Ltd. Rayong, Thailand Sterile, Nonpyrogenic Solution Store below 30°C Batch No. A20A007 MFD. 7 Jan 2020 EXP. 7 Jan 2022 Barcode 00002 (01)50085412528217(10)A20A007(17)220107 Baxter Logo THB9776 2000 ml Dianeal® PD-4 Low Calcium with 2.5% Dextrose EACH 100 ml CONTAINS 2.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE DIHYDRATE USP 5.08 mg MAGNESIUM CHLORIDE HEXAHYDRATE USP pH 5.2 (4.0 to 6.5) mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY 395 mOsmol/L(CALC) STERILE NON PYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSERT FOR FULL INFORMATION FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION KEEP OUT OF REACH OF CHILDREN AVOID EXCESSIVE HEAT SEE INSERT INDICATED FOR CHRONIC RENAL FAILURE PATIENTS BEING MAINTAINED ON PERITONEAL DIALYSIS DIRECTION TO BE USED AS DIRECTED BY THE PHYSICIAN STORAGE BELOW 30°C REG NO. 2A 95/59 THRS1109 BG Symbol MANUFACTURED BY: BAXTER MANUFACTURING (THAILAND) CO. LTD. RAYONG, THAILAND PD-4 2.5% Dianeal PD-4 Low Calcium with 2.5% Dextrose THB9776 6 X 2000 mL Each 100 ml contains Dextrose Hydrous USP 2.5 g Sodium Chloride USP 538 mg Sodium Lactate 448 mg Calcium Chloride Dihydrate USP 18.3 mg Magnesium Chloride Hexahydrate USP 5.08 mg pH 5.2 (4.0-6.5) Reg No. 2A 95/59 Manufacturing by Baxter Manufacturing (Thailand) Co., Ltd. Rayong, Thailand Sterile, Nonpyrogenic Solution Store below 30°C Batch No. A20A023 MFD. 10 Jan 2020 EXP. 10 Jan 2022 Barcode 00001 (01)500854 12528224(10)A20A023(17)220110 Baxter Logo THB9796IP 2000 ml Peritoneal Dialysis Solution Low Calcium with 4.5% Dextrose-IP Dianeal® PD-4 Low Calcium EACH 100 ml CONTAINS 4.25 g DEXTROSE HYDROUS 538 mg SODIUM CHLORIDE 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE DIHYDRATE 5.08 mg MAGNESIUM CHLORIDE HEXAHYDRATE pH 5.2 (4.5 to 6.5) mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY 483 mOsmol/L(CALC) STERILE NON PYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION KEEP OUT OF REACH OF CHILDREN AVOID EXCESSIVE HEAT INDICATED FOR CHRONIC RENAL FAILURE PATIENTS BEING MAINTAINED ON PERITONEAL DIALYSIS INDICATION/ADMINISTRATION AND COMPLETE INFORMATION – REFER PACKAGE INSERT STORAGE BELOW 30°C THA REG NO. 2A 93/59 THRS1131 AA Symbol NAME AND ADDRESS OF MANUFACTURER: BAXTER MANUFACTURING (THAILAND) CO., LTD. 7/398 MOO 6 MABYANGPORN, PLUAKDAENG, RAYONG, THAILAND 21140 Name and Address of Importer: Baxter (India) Pvt. Ltd., No. 219-1A, 1B,225/4B, Block C, Ground Floor, Kothari ware house, Opposite to Vegetarian Village, Madhavaram Red Hills Road Puzhal village, Ambattur Taluk, Tiruvallur District, Chennai – 600060 Tamil Nadu, India Import License Number: IL/FF-000400 RC/FF-002173 Telephone no., email address (in case of consumer complaint, Safety Reporting or Queries): Consumer Care No.: 0124-4603200 Consumer Care email ID: Customerservice_SHS_India@baxter.com PEITONEAL DIALYSIS SOLUTION LOW CALCIUM WITH 4.25% DEXTROSE-IP PD-4 4.25% DEXTROSE (Dianeal® PD-4) THB9796IP Each 100 ml contains Dextrose Hydrous 4.25 g Sodium Chloride 538 mg Sodium Lactate 448 mg Calcium Chloride Dihydrate 18.3 mg Magnesium Chloride Hexahydrate 5.08 mg pH 5.2 (4.5-6.5) Manufactured by BAXTER MANUFACTURING (THAILAND) CO., LTD., 7/398 MOO 6 MABYANGPORN, PLUAKDAENG, RAYONG, THAILAND, 21140 NAME AND ADDRESS OF IMPORTER: Baxter (India) Pvt. Ltd. No. 219-1A, 1B,225/4B, Block C, Ground Floor, Kothari ware house, Opposite to Vegetarian Village, Madhavaran Red Hills Road Puzhal village, Ambattur Taluk, Tiruvallur District, Chennai – 600060 TAMILNADU, India IMPORT LICENSE NUMBER: IL/FF-000400 RC/RF-002173 Sterile, Nonpyrogenic Solution Store below 30°C Batch No. A99A999 MFD. 99 Mar 9999 EXP. 99 Mar 9999 MRP Rs. 9999.99(incl. of all taxes) Net Quality – 6 U X 2000 mL. NAME, ADDRESS, TELEPHONE NO., EMAIL ADDRESS (IN CASE OF CONSUMER COMPLAINT, SAFETY REPORTING OR QUERIES): Baxter (India) Private Limited, 5 th Floor, Tower A, Building No. 9, DLF Cyber City, DLF Phase III, Gurgaon – 122002/ Haryana, India Consumer Care No.: 0124-4603200 Consumer Care email ID: Customerservice_SHS_India@baxter.com Rev.01 Barcode 00001 (01)8859656197969(10)X21SXXX(17)231120 Dianeal Representative Container Label THB9766 - 0941-0711.jpg Dianeal Representative Carton Label THB9766 - 0941-0711 Dianeal Representative Container Label THB9776 Dianeal Representative Carton Label THB9776 Dianeal Representative Container Label THB9796IP Dianeal Representative Carton Label THB9796IP