Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0701

This text provides important prescribing information regarding the temporary importation of DIANEAL Low Calcium Peritoneal Dialysis Solutions with different dextrose concentrations from Guangzhou, China for use in Automated Peritoneal Dialysis to address drug shortages. Baxter Healthcare Corporation is coordinating the importation with the US FDA as a response to potential shortages in the US market. The imported products are manufactured in Guangzhou, China and marketed in Hong Kong. The text outlines specific product details and emphasizes that importation or distribution by unauthorized entities is considered a violation of the law and subject to enforcement by the FDA. The text also includes a table with details about the imported products, their descriptions, and relevant product codes.*

This is a detailed information guide regarding the differences between the US-manufactured and China-manufactured DIANEAL Low Calcium Peritoneal Dialysis Solutions with Dextrose. It highlights the importance of monitoring serum calcium levels, proper usage, administration, and dosage. There are distinctions in product labeling, barcoding, container packaging, and administration procedures that healthcare providers and patients should be aware of. Additionally, it provides instructions on reporting adverse events associated with the imported products.*

This text provides instructions on how to report issues related to product quality, specifically for DIANEAL Peritoneal Dialysis Solution. It includes options for submitting reports online, via regular mail, or fax. Additionally, contact information for Baxter's Medical Information Service and Center for Home Care Services is given for inquiries and orders. The message is signed by Geovana Basso, M., Director of Americas Medical Affairs at Baxter Healthcare Corporation. It also mentions the availability of FDA approved prescribing information and references product comparison tables as attachments.*

This text provides a comparison of DIANEAL Peritoneal Dialysis Solutions, highlighting key differences between an imported product from Guangzhou, China and US FDA-approved products. It includes information on various types of DIANEAL solutions, their compositions, container types, and electrolyte concentrations. The text also mentions glucose percentages in the solutions and provides details on osmolality measurements.*

This text provides a comparison of 6000mL DIANEAL PD Solution Container Labels for APD. It highlights the differences between an imported product from Guangzhou, China and a US FDA approved product by Baxter. The labels show information such as the calcium content, dextrose percentage, and other safety-related details. The comparison indicates no differences in composition or safety information between the two products.*

This is a description of Baxter's imported product from Guangzhou, China, which includes US FDA approved 6000 ml DIANEAL Low Calcium PD Solution. The text mentions various types of solutions such as DIANEAL Low Gaictum P Solution and DIANEAL PB.2 PD Solution. The product also includes DIANEAL Dilyse Solution and PertonealBialysis Solution with different dextrose concentrations. Baxter's product is described as a safe and effective solution for various medical applications.*

This is a description of Dianeal Low Calcium Peritoneal Dialysis Solution with 1.5% Dextrose. It contains specific quantities of various ingredients like Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, and Magnesium Chloride. The solution has a measured osmolarity level and is aimed for intraperitoneal administration under the supervision of a physician. The packaging insert provides essential information, including cautions to ensure product sterility. The solution is stored under specific conditions until ready for use. It is manufactured by Baxter Healthcare in Guangzhou, China.*

This text is a detailed description of Dianeal Low Calcium Peritoneal Dialysis Solution with 2.5% Dextrose. It contains information about the composition of the solution, usage instructions, storage recommendations, and manufacturer details. The solution is intended for intraperitoneal administration and should only be used under the direction of a physician. Users are advised to read the package insert for full information before use and to discard the solution if leaks are found. The solution should be stored in a moisture barrier overwrap at room temperature until ready to use.*