Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0690

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Dianeal Low Calcium With Dextrose (NDC 0941-0690). 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 contains important prescribing information about the temporary importation of DIANEAL Low Calcium Peritoneal Dialysis Solution (2000 mL) from China by Baxter Healthcare Corporation, addressing drug shortages. It includes details on the product's fill volume, product codes, carton and bag quantities, and NDC codes for three lactate concentration variants (1.5%, 2.5%, 4.25%). It also highlights the calcium content differences compared to another DIANEAL product and advises monitoring serum calcium levels.*

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Dianeal Dhcp Letter 2 (Image 02)

A printed letter from Baxter discussing key differences in DIANEAL Low Calcium Peritoneal Dialysis Solution imported from China compared to U.S. products. It covers compatibility, labeling, barcoding issues, product packaging, and prescribing awareness. The letter also includes contact information for reporting adverse events via phone, fax, or online.*

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Dianeal Dhcp Letter 3 (Image 03)

A letter from Baxter Healthcare Corporation providing contact information for reporting product quality issues, ordering, and medical inquiries related to DIANEAL Low Calcium Peritoneal Dialysis Solution. It references FDA-approved prescribing information available on DailyMed and includes an electronic signature from Geovana Basso, M.D., Director of Americas Medical Affairs at Baxter.*

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Dianeal Dhcp Letter 4 (Image 04)

A data table comparing key differences among DIANEAL Peritoneal Dialysis Solutions for CAPD therapy from three sources: Imported Product (Guangzhou, China), U.S. FDA-Approved DIANEAL Low Calcium, and U.S. FDA-Approved DIANEAL PD-2. It details product names, labeled fill volumes, container types, bags per carton, indications, active ingredients including dextrose and electrolytes, electrolyte content per liter with low calcium, pH ranges, and additional osmolarity information for various dextrose concentrations.*

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Dianeal Dhcp Letter 5 (Image 05)

A data table comparing three DIANEAL Low Calcium products: Imported (Guangzhou, China), U.S. FDA-Approved DIANEAL Low Calcium, and U.S. FDA-Approved DIANEAL PD-2. It details storage conditions, expiration dating, container closure systems with images of solution bags, closure differences, and label languages. The imported product label is in Chinese, while FDA-approved products are labeled in English.*

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Dianeal Dhcp Letter 6 (Image 06)

A data table comparing labels for DIANEAL Low Calcium PD Solution containers used in peritoneal dialysis. It includes three label types: an Import Product from Guangzhou, China, a US FDA Approved 2000 mL DIANEAL Low Calcium PD Solution label, and a US FDA Approved 2000 mL DIANEAL PD-2 Solution label. Each column shows differences in label formatting, language, barcodes, fill volume, and safety information for the 2000 mL fill volume size.*

FDA Label Image

Dianeal Dhcp Letter 7 (Image 07)

The image shows the labels of Baxter DIANEAL Low Calcium Peritoneal Dialysis Solutions. The central label is for DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 2000 mL, listing sodium, calcium, lactate, chloride, and magnesium content. To the right is DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose, 2000 mL, and to the left is a similar label in Chinese for a 2000 mL DIANEAL Low Calcium solution. All labels include storage and usage instructions and the Baxter brand.*

FDA Label Image

Dianeal Dhcp Letter 8 (Image 08)

Packaging label for DIANEAL Low Calcium Peritoneal Dialysis Solution with 4.25% Dextrose in 2000 mL bags. The label includes U.S. FDA approved versions and an import product from Guangzhou, China. Active electrolytes and dextrose concentrations are listed, along with instructions to add potassium chloride only under physician supervision. Produced by Baxter Healthcare Corporation.*

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Representative Dianeal Container Label (Image 09)

This text panel contains detailed product information for Dianeal PD-4 Ultrabag, a low calcium peritoneal dialysis solution with lactate and 1.5% glucose. It lists ingredient strengths per 100 mL, ionic concentrations, product characteristics, usage indications, precautions, storage instructions, and manufacturer details. The labeler is Baxter Healthcare (Guangzhou) Co., Ltd.*

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Representative Dianeal Carton Label (Image 10)

A label for Low Calcium Peritoneal Dialysis Solution with 1.5% dextrose, specifying lactate-G1.5. The label includes batch details such as lot number, manufacturing date, validity period, and packaging information indicating 8 bags of 2L each in PD-4 UltraBag format. A barcode and serial number are also visible.*

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Representative Dianeal Container Label (Image 11)

Text panel from a Baxter Dianeal PD-4 Ultrabag showing information on low calcium peritoneal dialysis solution with Lactate-G2.5%. It lists strengths and ingredients per 100 mL including dextrose, sodium chloride, calcium chloride, magnesium chloride, and sodium lactate with ionic concentrations. Additional sections cover product characteristics, indications, usage instructions, storage, and regulatory license details.*

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Representative Dianeal Carton Label (Image 12)

Label for Low Calcium Peritoneal Dialysis Solution (Lactate-G 2.5%) containing 1.5% dextrose. The packaging specifies 2-liter bags with a total of 8 bags per package. It includes barcode and lot number, manufacturing date, and expiration validity, all of which are placeholder values.*

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Representative Dianeal Container Label (Image 13)

A label panel for Dianeal PD-4 Ultrabag, a low calcium peritoneal dialysis solution with 4.25% glucose. The panel lists ingredients with their concentrations, characteristics of the product, indications for use in kidney failure patients, usage warnings, storage instructions, and manufacturer details from Baxter Healthcare (Guangzhou) Co., Ltd. It includes calcium, sodium, magnesium, and lactate ionic concentrations.*

FDA Label Image

Representative Dianeal Carton Label (Image 14)

Label for Low Calcium Peritoneal Dialysis Solution (Lactate-G 4.25%) containing 1.5% dextrose. The label indicates packaging as 2 liters by 8 bags, includes a lot number, manufacturing date, product type PD-4 UltraBag, and a barcode with a serial number.*

* 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.