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
6AB5177E 2000ml
(APPROX 80ml EXCESS)
3000ml NOMINAL SIZE CONTAINER
BaxterLogo
Dianeal® PD-2
Peritoneal Dialysis Solution
With 2.5% Dextrose
EACH 100ml CONTAINS2.5 g DEXTROSE HYDROUS USP 538 mg
SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM
CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP
pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 3.5 MAGNESIUM 0.5 CHLORIDE 96
LACTATE 40
OSMOLARITY396 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 (UNDER 25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ambu-Flex TMIII CONTAINER PL-146 ® PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-42533
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN
Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China
2.5 PD-2 WITH 2.5% DEXTROSE 2000mlX6
LOT G00000000 EXP JAN 00
6AB5177E
S/N 0000
6AB9747E 2000ml
(APPROX 80ml EXCESS)
3000ml NOMINAL SIZE CONTAINER
BaxterLogo
Dianeal® Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 4.25% Dextrose
EACH 100ml CONTAINS4.25 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 (4.5 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 (UNDER 25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ambu-Flex TMIII CONTAINER PL-146 ®PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-42532
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN
Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China
4.25 LOW CALCIUM WITH 4.25% DEXTROSE 2000mlX6
LOT G00000000 EXP JAN 00
6AB9747E
S/N 0000
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