Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0705

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dianeal Low Calcium With Dextrose (NDC 0941-0705). 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

Representative Dianeal Carton Label (FNB5203GN)

Label for DIANEAL LOW CALCIUM WITH DEXTROSE PD-4, 4.25% dextrose injection solution. The label includes product code FNB5203GN and lot number S24A12345 with expiration date 12.12.2024. There is both English and Chinese text and multiple barcodes on a pink background. The label is associated with Vantive US Healthcare LLC.*

FDA Label Image

Representative Dianeal Container Label (FNB5203GN)

Label for DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose by Baxter, in a 5000 mL container. The solution contains specific amounts of dextrose, sodium lactate, sodium chloride, calcium chloride, and magnesium chloride. The label includes storage instructions, cautions, warnings, and directions, with multilingual text including English, Chinese, Korean, and other languages. Manufactured by Baxter Healthcare S.A., Singapore Branch.*

FDA Label Image

Dianeal Dhcp Letter 1 (Image 01)

This document is an important prescribing information letter dated October 23, 2024, regarding the temporary importation of DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose from Singapore due to drug shortages in the U.S. It includes details about product importation, regulatory status, and specifics on product codes, volumes, packaging, and monitoring recommendations.*

FDA Label Image

Dianeal Dhcp Letter 2 (Image 02)

This text panel provides detailed information about DIANEAL Low Calcium Peritoneal Dialysis Solution with 4.25% Dextrose, including clinical usage practices, compatibility of the Luer-lock connector with US products, barcode discrepancies between Singapore imported and US labelings, prescription availability, and reporting adverse events. It highlights key differences between imported and FDA-approved products and offers references to prescribing information and adverse event reporting resources.*

FDA Label Image

Dianeal Dhcp Letter 3 (Image 03)

A text page containing contact information for Baxter's Medical Information Service and Baxter's Center for Home Care Services for questions or orders related to DIANEAL Solution for Peritoneal Dialysis. The letter is signed by Geovana Basso, M.D., Director of Americas Medical Affairs at Baxter Healthcare Corporation, with a date of October 23, 2024. It also references attachments with product comparison tables and notes that Baxter and DIANEAL are registered trademarks of Baxter International Inc.*

FDA Label Image

Dianeal Dhcp Letter 4 (Image 04)

A comparison table titled 'Key differences of DIANEAL Peritoneal Dialysis Solutions for APD therapy' from Baxter. It contrasts three products: imported DIANEAL Low Calcium from Singapore, US FDA Approved DIANEAL Low Calcium, and US FDA Approved DIANEAL PD2, listing attributes including product name, labeled fill volume, container type, bags per carton, indications, active ingredient dextrose concentration, active electrolyte ingredients, electrolyte content per liter, pH, additional information, and label color and languages.*

FDA Label Image

Dianeal Dhcp Letter 6 (Image 05)

This table compares three DIANEAL Low Calcium product versions: Imported from Singapore, US FDA Approved DIANEAL Low Calcium, and US FDA Approved DIANEAL PD2. It details storage conditions (room temperature, brief exposure to 40°C acceptable), expiration dating (24 months), container closure systems shown via images, and closure differences highlighting color-coded luer connectors and pull ring caps corresponding to dextrose concentration (4.25%). The labeler Baxter is noted.*

FDA Label Image

Dianeal Dhcp Letter 6 (Image 06)

A comparison table of 5000 mL DIANEAL PD Solution with 4.25% Dextrose container labels for three versions: Imported Product from Singapore, US FDA Approved DIANEAL Low Calcium PD Solution, and US FDA Approved DIANEAL PD-2 PD Solution. The labels show product names, active ingredient concentrations, usage instructions, warnings, and manufacturing details.*

* 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.