Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0696

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 0941-0696). 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)

This document provides important prescribing information dated October 21, 2024, regarding the temporary importation of DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose and DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose from Baxter’s facility in Guangzhou, China, due to a drug shortage. It includes product codes, package sizes, and NDC codes for these imported solutions.*

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Dianeal Dhcp Letter 2 (Image 02)

A text panel discussing key information about DIANEAL PD-2 with 2.5% Dextrose and DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solutions with 4.25% Dextrose. It compares these China-imported products with U.S. manufactured versions for APD use, highlighting formulation differences, packaging, barcoding, and user guidance. The panel also provides instructions for reporting adverse events through the FDA MedWatch program via online, fax, or phone.*

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Dianeal Dhcp Letter 3 (Image 03)

This is a correspondence letter from Geovana Basso, M.D., Director of Americas Medical Affairs at Baxter Healthcare Corporation, addressing the use and ordering information for Dianeal Peritoneal Dialysis Solution with 2.5% and 4.25% Dextrose. The letter references FDA approved prescribing information and provides contact details for product feedback and order placement.*

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Dianeal Dhcp Letter 4 (Image 04)

A comparative table titled 'Key differences of DIANEAL Peritoneal Dialysis Solutions for APD therapy' outlining four products: DIANEAL Low Calcium 4.25% Dextrose, DIANEAL PD-2 2.5% Dextrose, and two U.S. FDA-approved DIANEAL products (Low Calcium and PD2) with various volume options, container types, bag counts, indications for use, active ingredient strengths of dextrose, and active electrolyte ingredients. It details volumes ranging from 1000 mL to 3000 mL and active components including sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and varying dextrose concentrations.*

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Dianeal Dhcp Letter 5 (Image 05)

A comparative data table showing electrolyte content, pH, additional dextrose information, storage conditions, expiration dating, and container closure systems for four products: two imported DIANEAL peritoneal dialysis solutions low calcium and standard calcium from Guangzhou, China, and two U.S. FDA Approved DIANEAL PD-2 products low calcium and standard calcium. The table includes detailed electrolyte concentrations, pH ranges, dextrose concentrations and osmolarity, storage temperature guidelines, shelf life durations, and photos of each product's fluid bag with attached tubing.*

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Dianeal Dhcp Letter 6 (Image 06)

An illustrated comparison chart showing different container closures for DIANEAL PD-2 with varying dextrose concentrations from imported (Guangzhou, China) and U.S. FDA approved products. It highlights closure colors and tips, including green and blue frangible luer connectors with protective tips, with explanations of color-coded pull ring caps indicating solution dextrose concentration (green for 2.5%, red for 4.25%).*

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Dianeal Dhcp Letter 7 (Image 07)

Label images for DIANEAL Peritoneal Dialysis Solution 2000 mL containers showing three variants: an imported product from Guangzhou, China with 4.25% dextrose; a US FDA approved DIANEAL Low Calcium PD Solution with 4.25% dextrose; and a US FDA approved DIANEAL PD-2 with 4.25% dextrose. Labels include product name, strength, volume, and manufacturer Baxter information.*

FDA Label Image

Dianeal Dhcp Letter 8 (Image 08)

A data table comparing the product label information for three versions of DIANEAL PD-2 peritoneal dialysis solutions with 2.5% dextrose by Baxter. It includes details such as NDC numbers, volume (2000 mL), product names, active ingredient concentrations, storage instructions, packaging type (Ambu-Flex III container), and manufacturer information for imported and FDA-approved products from Guangzhou, China, and the U.S.*

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Representative Dianeal Container Label (Image 09)

Label for Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose, a 2000 ml solution container by Baxter. The label lists active ingredients including dextrose 2.5 g, sodium chloride 448 mg, sodium lactate 25.7 mg, calcium chloride 5.08 mg, and magnesium chloride 0.5 mg per 100 mL with a pH of 5.2 to 6.5. It specifies that potassium chloride must be added only under physician direction, and cautions to maintain product sterility. Manufactured by Baxter Healthcare (Guangzhou) Co. Ltd in China.*

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Representative Dianeal Carton Label (Image 10)

This image shows a label for DIANEAL PD-2 WITH DEXTROSE 2.5%, an intraperitoneal injection solution. The visible text includes the strength 2.5% dextrose and a volume notation of 2000 mL, with batch and expiration information partially visible. The label indicates a lot number and expiration date in January 2000. The product is by Vantive US Healthcare LLC.*

FDA Label Image

Representative Dianeal Container Label (Image 11)

The image shows a 2000 mL container label for Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose by Baxter. It lists active ingredients with concentrations per 100 mL and indicates sterile, non-pyrogenic status. Warning and storage instructions are provided, along with manufacturer details for Baxter Healthcare (Guangzhou) Co Ltd in China.*

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Representative Dianeal Carton Label (Image 12)

Partial label showing '4.25 LOW CALCIUM WITH 4.25% DEXTROSE' along with volume '2000ml X6'. Includes lot number, expiration date 'EXP JAN 00', and a code '6AB9747E'. This label belongs to DIANEAL PD-2 WITH DEXTROSE injection solution by Vantive US Healthcare LLC.*

* 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.