FDA Label for Dianeal Low Calcium With Dextrose
View Indications, Usage & Precautions
Dianeal Low Calcium With Dextrose Product Label
The following document was submitted to the FDA by the labeler of this product Vantive Us Healthcare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package/Label Principal Display Panel
6AB9768E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER
BaxterLogo
Dianeal
®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 1.5% Dextrose
EACH 100 ml CONTAINS1.5g 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 (4.5 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
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ultrabag TMCONTAINER PL-146 PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62710
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN
Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China
Low Calcium 1.5% Dextrose
1.5 LOW CALCIUM WITH 1.5% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00
6AB9768E
S/N 0000
6AB9778E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER
BaxterLogo
Dianeal
®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 2.5% Dextrose
EACH 100ml CONTAINS2.5g 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 (4.5 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
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ultrabag TMCONTAINER PL-146 PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62709
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN
Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China
Low Calcium 2.5% Dextrose
2.5 LOW CALCIUM WITH 2.5% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00
6AB9778E
S/N 0000
6AB9798E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER
BaxterLogo
Dianeal
®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 4.25% Dextrose
EACH 100ml CONTAINS4.25g 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 (4.5 to 6.5)
mEq/LSODIUM 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
WARNINGEXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
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
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ultrabag TMCONTAINER PL-146 PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62711
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN
Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China
Low Calcium 4.25% Dextrose
4.25 LOW CALCIUM WITH 4.25% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00
6AB9798E
S/N 0000
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