DIANEAL LOW CALCIUM WITH DEXTROSE Dailymed

Health Care Provider Letter

Package/label Principal Display Panel

BaxterLogo THB9766 2000 ml

Dianeal® PD-4 Low Calcium with 1.5% Dextrose

EACH 100ml CONTAINS1.5 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 pH5.2 (4.0 to 6.5) mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY344 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 CAUTIONSSQUEEZE 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

DIRECTIONTO BE USED AS DIRECTED BY THE PHYSICIAN

STORAGEBELOW 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

BaxterLogo THB9776 2000 ml

Dianeal® PD-4 Low Calcium with 2.5% Dextrose

EACH 100 ml CONTAINS2.5 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 pH5.2 (4.0 to 6.5) mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY395 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 CAUTIONSSQUEEZE 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

DIRECTIONTO BE USED AS DIRECTED BY THE PHYSICIAN STORAGEBELOW 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

BaxterLogo THB9796IP 2000 ml

Peritoneal Dialysis Solution Low Calcium with 4.5% Dextrose-IP Dianeal® PD-4 Low Calcium

EACH 100 ml CONTAINS4.25 g DEXTROSE HYDROUS 538 mg SODIUM CHLORIDE 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE DIHYDRATE 5.08 mg MAGNESIUM CHLORIDE HEXAHYDRATE pH5.2 (4.5 to 6.5) mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40 OSMOLARITY483 mOsmol/L(CALC) STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONSSQUEEZE 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

STORAGEBELOW 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 ^thFloor, 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