Dianeal Low Calcium With Dextrose Injection, Solution
FDA Label NDC 0941-0701

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vantive Us Healthcare Llc for the product Dianeal Low Calcium With Dextrose (NDC 0941-0701). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Dianeal Representative Container Label (Image 09)

Dianeal Representative Container Label (Image 09)

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

Dianeal Representative Carton Label (Image 10)

Dianeal Representative Carton Label (Image 10)

1.5 LOW CALCIUM WITH 1.5% DEXTROSE 6000mlX2
LOT G00000000 EXP JAN 00 6AB9770E S/N 0000

Dianeal Representative Container Label (Image 11)

Dianeal Representative Container Label (Image 11)

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

Dianeal Representative Carton Label (Image 12)

Dianeal Representative Carton Label (Image 12)

2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2
LOT G00000000 EXP JAN 00 6AB9771E S/N 0000

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