Label: DIANEAL LOW CALCIUM WITH DEXTROSE- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

  • NDC Code(s): 0941-0711-01, 0941-0711-06, 0941-0713-01, 0941-0713-06, view more
    0941-0715-01, 0941-0715-06
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 7, 2024

If you are a consumer or patient please visit this version.

  • Health Care Provider Letter

    Dianeal DHCP 1
    Dianeal - DHCP 2
    Dianeal - DHCP 3
    Dianeal - DHCP 4
    Dianeal - DHCP 5
    Dianeal - DHCP 6
    Dianeal - DHCP 7
    Dianeal - DHCP 8
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Dianeal Representative Container Label THB9766 - 0941-0711.jpg

    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

    Dianeal Representative Carton Label THB9766 - 0941-0711

    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

    Dianeal Representative Container Label THB9776

    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

    Dianeal Representative Carton Label THB9776

    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

    Dianeal Representative Container Label THB9796IP

    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

    Dianeal Representative Carton  Label THB9796IP

    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

  • INGREDIENTS AND APPEARANCE
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0711
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE1.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0711-066 in 1 CARTON10/23/2024
    1NDC:0941-0711-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/23/2024
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0713
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE2.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0713-066 in 1 CARTON10/23/2024
    1NDC:0941-0713-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/23/2024
    DIANEAL LOW CALCIUM WITH DEXTROSE 
    sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0715
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE4.25 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE18.3 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0715-066 in 1 CARTON10/23/2024
    1NDC:0941-0715-012000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/23/2024
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Manufacturing (Thailand) Co., Ltd661742706analysis(0941-0711, 0941-0713, 0941-0715) , label(0941-0711, 0941-0713, 0941-0715) , manufacture(0941-0711, 0941-0713, 0941-0715) , pack(0941-0711, 0941-0713, 0941-0715) , sterilize(0941-0711, 0941-0713, 0941-0715)