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

This text provides important prescribing information regarding the temporary importation of DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose and DIANEAL Low Calcium Peritoneal Dialysis Solution with 4.25% Dextrose from Guangzhou, China. Baxter Healthcare Corporation is coordinating with the U.S. FDA to address drug shortages by importing these solutions for use in Automated Peritoneal Dialysis. Healthcare professionals are advised to carefully review the product specifications and details provided with the imported solutions. Baxter has initiated the temporary importation of these solutions for use in Ambulatory Peritoneal Dialysis therapy. Unauthorized importation or distribution of these products in the U.S. by entities other than Baxter is a violation of the Federal Food, Drug, and Cosmetic Act. The text also lists the imported product names and codes for reference.*

The text provides detailed information regarding DIANEAL Peritoneal Dialysis Solutions with different compositions and considerations for usage of products imported from China. It covers differences in calcium levels, administration, dosages, and packaging between U.S.-manufactured and China-manufactured products. Additionally, it mentions color-coded labeling, barcoding discrepancies, and the importance of healthcare providers being knowledgeable about these variations. Tables are included to help compare key differences and label images for better understanding and reference. Healthcare providers should pay attention to these differences to ensure the correct product usage and avoid any potential issues.*

This text provides information on how to report product quality issues through the Borir - Product Feedback Portal using the attached Product Comparison Tables document with code 12042. Users can report issues related to product quality through this feedback channel.*

This is a description of a peritoneal dialysis solution imported from Guangzhou, China and approved by the US FDA. The product is a 2000mL DIANEAL PD Solution with low calcium. It contains 2.5% Dextrose for peritoneal dialysis. The solution is from the brand Baxter and is labeled as Dianeal PD2. It is suitable for medical use and has specific instructions and composition details mentioned in the text.*

This is information about a Baxter Dianeal PD-2 Peritoneal Dialysis Solution containing 2.5% Dextrose. Each 100ml of the solution contains various compounds as listed. It is for intraperitoneal administration only and should be used as directed by a physician. The solution is sterile, non-pyrogenic, but caution is advised to inspect the inner bag for leaks. It should be stored in a moisture barrier overwrap at room temperature until ready to use. Additionally, it mentions that potassium chloride should only be added under the direction of a physician.*

This text is a detailed description of Dianeal® Low Calcium Peritoneal Dialysis Solution by Baxter, containing information on ingredients, concentrations, osmolarity, storage instructions, warnings, cautions, and manufacturer details. It also highlights the necessity of a physician's direction for adding potassium chloride and proper usage during peritoneal dialysis procedures.*