Dianeal Low Calcium With Dextrose

Dianeal Low Calcium With Dextrose
SPL v4
SPL
SPL Set ID b2b780d3-26ac-4e7c-a0f2-78991bee32a8
Route
INTRAPERITONEAL
Published
Effective Date 2024-10-23
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dextrose (1.5 g) Chloride Ion (538 mg) Lactic Acid, Unspecified Form (448 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Completed Since 2024-10-23 Until 2025-04-21

Description

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: [email protected] 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: [email protected] Rev.01 Barcode 00001 (01)8859656197969(10)X21SXXX(17)231120


Medication Information

Description

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: [email protected] 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: [email protected] Rev.01 Barcode 00001 (01)8859656197969(10)X21SXXX(17)231120

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: [email protected]

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: [email protected]

Rev.01

Barcode

00001

(01)8859656197969(10)X21SXXX(17)231120


Structured Label Content

Health Care Provider Letter
Package/label Principal Display Panel (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: [email protected]

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: [email protected]

Rev.01

Barcode

00001

(01)8859656197969(10)X21SXXX(17)231120


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)