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
6AB9770E 6000ml
(APPROX 225ml EXCESS)
BaxterLogo
Dianeal
®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
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 (4.5 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 (UNDER 25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ambu-Flex™ IIICONTAINER PL-146 ®PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)
HK-42530
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 6000mlX2
LOT G00000000 EXP JAN 00 6AB9770E S/N 0000
6AB9771E 6000ml
(APPROX 225ml EXCESS)
BaxterLogo
Dianeal
®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 2.5% Dextrose
EACH 100ml CONTAINS2.5 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 (4.5 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 (UNDER 25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
Ambu-Flex™ IIICONTAINER PL-146 ®PLASTIC
MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)
HK-42531
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
2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2
LOT G00000000 EXP JAN 00 6AB9771E S/N 0000
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