Dianeal Low Calcium With Dextrose Injection, Solution
FDA Label NDC 0941-0696

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 0941-0696). 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

Representative Dianeal Container Label (Image 09)

Representative Dianeal Container Label (Image 09)

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

Representative Dianeal Carton Label (Image 10)

Representative Dianeal Carton Label (Image 10)

2.5 PD-2 WITH 2.5% DEXTROSE 2000mlX6
LOT G00000000 EXP JAN 00
6AB5177E
S/N 0000

Representative Dianeal Container Label (Image 11)

Representative Dianeal Container Label (Image 11)

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

Representative Dianeal Carton  Label (Image 12)

Representative Dianeal Carton Label (Image 12)

4.25 LOW CALCIUM WITH 4.25% DEXTROSE 2000mlX6
LOT G00000000 EXP JAN 00
6AB9747E
S/N 0000

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