Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0703

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dianeal Low Calcium With Dextrose (NDC 0941-0703). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vantive Us Healthcare Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Dianeal Dhcp Letter 1 (Image 01)

A text document titled Important Prescribing Information dated October 22, 2024, describing the temporary importation of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solutions with 1.5% and 2.5% Dextrose (6000 mL) from Baxter's Guangzhou, China facility for use in Automated Peritoneal Dialysis due to U.S. supply shortages. The notice details coordination with the FDA, product codes, packaging, and guidelines concerning the temporary import during the shortage period.*

FDA Label Image

Dianeal Dhcp Letter 2 (Image 02)

This text panel provides detailed information about DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with Dextrose, including differences in calcium content between US-manufactured and China-imported products, compatibility notes, barcode scanning issues, and prescribing considerations. It also includes reporting instructions for adverse events related to these imported products.*

FDA Label Image

Dianeal Dhcp Letter 3 (Image 03)

A letter addressing product quality issues and contact information for Baxter Healthcare Corporation regarding DIANEAL Peritoneal Dialysis Solution. It provides instructions for reporting issues online, via mail or fax, and includes contact numbers for medical information and ordering. The letter is signed by Geovana Basso, M.D., Director of Americas Medical Affairs.*

FDA Label Image

Dianeal Dhcp Letter 4 (Image 04)

A data table comparing key differences of DIANEAL Peritoneal Dialysis Solutions for APD therapy, including an imported product from Guangzhou, China, and two US FDA-approved products DIANEAL Low Calcium (2.5 mEq/L) and DIANEAL PD2. The table details product name, labeled fill volume, container type, bags per carton, indications, active ingredients (dextrose and electrolytes), electrolyte content per liter, pH, and additional osmolarity information for each product.*

FDA Label Image

Dianeal Dhcp Letter 5 (Image 05)

A comparison table showing three versions of DIANEAL Low Calcium (2.5 mEq/L) intraperitoneal injection solution from different sources: Imported Product (Guangzhou, China), US FDA-Approved Product DIANEAL Low Calcium, and US FDA-Approved Product DIANEAL PD2. The table includes storage conditions (room temperature 25°C/77°F, brief exposure to 40°C safe), expiration dating (24 months), images of the container closure system (fluid bags with tubing), and close-up images of container closures showing different port designs and labeled concentrations (1.5% and 2.5%). The labeler Baxter is noted in the top corner.*

FDA Label Image

Dianeal Dhcp Letter 6 (Image 06)

A comparison table detailing container closure differences for three versions of DIANEAL Low Calcium injection solution: Imported (Guangzhou, China), US FDA-Approved DIANEAL Low Calcium, and US FDA-Approved DIANEAL PD2. It highlights features like the color of the frangible at the luer connector and pull ring cap color-coding indicating dextrose concentration, with blue or green codes for 1.5% or 2.5% dextrose respectively. The table includes the Baxter logo in the top right corner.*

FDA Label Image

Dianeal Dhcp Letter 7 (Image 07)

A data table comparing three 6000 mL DIANEAL PD solution container labels for automated peritoneal dialysis (APD). It contrasts the imported product from Guangzhou, China, the US FDA approved DIANEAL Low Calcium PD Solution, and the US FDA approved DIANEAL PD-2 PD Solution, highlighting differences in label layout, proprietary names, ingredient annotations, and manufacturer information from Baxter.*

FDA Label Image

Dianeal Dhcp Letter 8 (Image 08)

Packaging labels for DIANEAL Low Calcium with Dextrose peritoneal dialysis solutions from Baxter. The image shows three distinct labels: an imported product label for 6000 mL from Guangzhou, China; a US FDA approved DIANEAL Low Calcium PD Solution (2.5 mEq/L) label for 6000 mL; and a US FDA approved DIANEAL PD-2 PD Solution with 2.5% Dextrose label for 6000 mL. Each label includes details about sodium, chloride, calcium, magnesium, and dextrose content, usage instructions, manufacturer information, and plastic container specifications.*

FDA Label Image

Dianeal Representative Container Label (Image 09)

Label of DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose by Baxter. The label lists active components in 100 mL including dextrose 1.5 g, sodium chloride 538 mg, sodium lactate 448 mg, calcium chloride 18.3 mg, magnesium chloride 9 mg, with pH 5.2 to 6.5 and osmolarity 344 mOsmol/L. The solution is sterile, non-pyrogenic, intended for intraperitoneal dialysis administration. The label also includes storage, usage, and manufacturer information, specifying use under physician direction.*

FDA Label Image

Dianeal Representative Carton Label (Image 10)

Label for DIANEAL LOW CALCIUM WITH 1.5% DEXTROSE injection solution showing volume 6000 mL x 2. The label includes lot number, expiration date (JAN 00), and serial number information. The product is an intraperitoneal solution supplied by Vantive US Healthcare LLC.*

FDA Label Image

Dianeal Representative Container Label (Image 11)

Label for Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose by Baxter. The 6000 mL injection solution contains sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and dextrose with specified strengths per 100 mL. It is sterile, nonpyrogenic, for intraperitoneal use, and provided in an Ambu-Flex III Plastic container. Manufactured by Baxter Healthcare (Guangzhou) Co Ltd, China, with instructions for physician-directed use and storage guidance.*

FDA Label Image

Dianeal Representative Carton Label (Image 12)

A text-based label panel displaying 'LOW CALCIUM WITH 2.5% DEXTROSE 6000mIX2,' a lot number 'G00000000,' an expiration date 'JAN 00,' and an alphanumeric code '6AB9771E' accompanied by 'S/N 0000.' The label indicates product concentration and batch information.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.