Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0713

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 0941-0713). 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 1 (Image 01)

This document provides prescribing information regarding the temporary importation of ANEAL PD-4 Low Calcium Peritoneal Dialysis Solutions with Dextrose from Thailand. The purpose is to address drug shortages in the United States market. It explains the approval process by Baxter and coordination with the FDA for this temporary solution. It highlights the differences in calcium content between DIANEAL PD-4 and DIANEAL PD-2 solutions, emphasizing the need to monitor patients' serum calcium levels.*

FDA Label Image

Dianeal (DHCP 2)

This is a detailed technical document from the company Baxter discussing the differences between their DIANEAL medical products manufactured in the US and Thailand. It provides information about various variants of DIANEAL solutions for peritoneal dialysis, including composition, dosage, and compatibility with dialysis sets. The document also mentions the availability of DIANEAL products in the US only by prescription and highlights the importance of healthcare providers being aware of packaging and labeling variations between US and Thailand imported products. Additionally, it includes instructions on reporting adverse events related to the imported medical products.*

FDA Label Image

Dianeal (DHCP 3)

FDA Label Image

Dianeal (DHCP 4)

This is a comparison table showing key differences between DIANEAL Peritoneal Dialysis Solutions imported from Thailand and US FDA-approved products. It lists various products such as DIANEAL PD4 Low Calcium, DIANEAL Low Calcium, and DIANEAL PD2 with their respective compositions and container sizes. The table also mentions the indications for use, ingredients like Dextrose and Sodium Chloride, and electrolyte contents like Calcium and Magnesium. This information helps healthcare professionals in selecting the appropriate peritoneal dialysis solution for continuous ambulatory peritoneal dialysis (CAPD) therapy.*

FDA Label Image

Dianeal (DHCP 5)

This is product information for Baxter Thailand Imported US FDA-Approved PD Solutions. The text includes details of different types of solutions and their concentrations, as well as instructions for use such as the need for external clamps and coding for solution identification. These solutions contain various concentrations of glucose and are intended for peritoneal dialysis.*

FDA Label Image

Dianeal (DHCP 6)

This text appears to be a comparison of DIANEAL PD Solution Container Labels for Continuous Ambulatory Peritoneal Dialysis (CAPD), specifically discussing the differences in the container labels for various fill volumes proposed for import. The labels for the U.S. FDA-approved 1500 mL, 2500 mL, and 3000 mL solution fill volumes have minor variations in product code, NDC, fill volume, and barcode, with no differences in composition except for minor variations in active pharmaceutical ingredient quantities. The labels mention DIANEAL Low Calcium PD Solution and DIANEAL PD22 PD Solution with 1.5% Dextrose for Peritoneal Dialysis.*

FDA Label Image

Dianeal (DHCP 7)

FDA Label Image

Dianeal (DHCP 8)

This is a description of a Baxter DIANEAL PD-2 Peritoneal Dialysis Solution in a 2,000mL package approved by the US FDA. The solution is low in calcium (2.5 mEq/L) and contains 4.25% Dextrose. It is suitable for peritoneal dialysis procedures.*

FDA Label Image

Dianeal Representative Container Label Thb9766 (0941-0711.jpg)

This text appears to be a description of a medical product. It includes information about Baxter 2000m solution, Dianeal PD-4 Low Calcium with 1.5% Dextrose content, and various components like glucose, sodium, calcium, magnesium, chloride, and lactate. The text mentions specific instructions for use, sterile and non-pyrogenic nature of the product, and a reminder to follow guidance from a healthcare professional. There is also a reference to additional details available on the packaging for full information.*

FDA Label Image

Dianeal Representative Carton Label Thb9766 (0941-0711)

Description: This is a product label for Dianeal PD-4 Low Calcium solution with 1.5% Dextrose. It is a sterile and nonpyrogenic solution containing Dextrose Hydrous, Sodium Chloride, Sodium Lactate, Calcium Chloride, and Magnesium Chloride. The product is manufactured by Baxter in Thailand and comes in a 6 X 2000 mL packaging. The batch number is A20A007 with an expiration date of 7th Jan 2022. The pH of the solution is 5.2.*

FDA Label Image

Dianeal Representative Container Label Thb9776 (Image 11)

This text provides information about a solution used for peritoneal dialysis in patients with chronic renal failure. The solution contains dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. It is sterile and non-pyrogenic, with specific instructions for storage and usage. It is important to read the package insert for full details before use and to discard the solution if leaks are found or if it is not clear. The product should be used under the direction of a physician and is indicated for intraperitoneal administration only.*

FDA Label Image

Dianeal Representative Carton Label Thb9776 (Image 12)

This is a description of a medical solution called Dianeal PD-4 Low Calcium with 2.5% Dextrose. The solution is sterile, nonpyrogenic, and manufactured by Baxter Manufacturing in Thailand. Each 100 ml of the solution contains various ingredients such as Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride Dihydrate, and Magnesium Chloride Hexahydrate. The solution has a pH of 5.2 and should be stored below 30°C. The batch number is A2Z0A023 with a manufacturing date of 10 Jan 2020 and expiration date of 10 Jan 2022.*

FDA Label Image

Dianeal Representative Container Label Thb9796ip (Image 13)

This is information about Baxter Peritoneal Dialysis Solution with Low Calcium and 4.25% Dextrose. It includes details about the contents, composition, storage instructions, manufacturer's name and address, and importer's details. The solution is indicated for chronic renal failure patients undergoing peritoneal dialysis. It should be used for intraperitoneal administration only. The packaging includes cautions and instructions for safe use, storage below 3°C, and contact information for consumer care in case of complaints or queries.*

FDA Label Image

Dianeal Representative Carton Label Thb9796ip (Image 14)

This is a description of a Peritoneal Dialysis Solution with low calcium and 4.25% dextrose. The solution contains various components such as Dextrose Hydrous, Sodium Chloride, Sodium Lactate, Calcium Chloride Dihydrate, and Magnesium Chloride Hexahydrate. The pH level is 5.2 with an expiration date mentioned in the text. It is manufactured by Baxter and includes the manufacturer's details such as address and contact information. The solution is sterile, nonpyrogenic, and should be stored below 30°C.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.