Extraneal Injection, Solution
Product Images NDC 0941-0707

This text provides important information regarding the temporary importation of EXTRANEAL Peritoneal Dialysis Solution containing 7.5% Icodextrin from Singapore for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) to address drug shortages in the United States. Baxter Healthcare Corporation is coordinating with the U.S. Food and Drug Administration (FDA) for this importation; however, it's important to note that the product has not been approved by the FDA when manufactured in Baxter's facility in Woodlands, Singapore. The text includes details on the product codes, fill volumes, and notes that there are no clinically relevant differences between the Singapore-manufactured and US-manufactured CAPD products. This information is crucial for healthcare professionals involved in peritoneal dialysis therapy to ensure accurate usage and administration of the imported EXTRANEAL solution.*

This text provides valuable information about the differences between the EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis products manufactured in Singapore and the US. It discusses differences in electrolyte concentrations, product design, labeling, and packaging. It also includes guidance on reporting adverse events and quality issues related to the imported product. Healthcare providers are advised to be aware of these distinctions and follow alternative procedures to ensure the correct product is used for individual patients. More details can be found in the provided Product Comparison Tables and by referring to the FDA-approved full prescribing information for EXTRANEAL (icodextrin) Peritoneal Dialysis Solution on DailyMed.*

This text is a letter from Baxter Healthcare Corporation regarding the use of their product, EXTRANEAL Peritoneal Dialysis Solution. It provides contact information for inquiries and ordering purposes. The letter is signed by Geovana Basso, M.D., who is the Director of Americas Medical Affairs at Baxter Healthcare Corporation. The trademarks mentioned in the letter are EXTRANEAL and ULTRABAG.*

This text provides key differences between EXTRANEAL Peritoneal Dialysis Solution imported from Singapore and the US FDA approved product. It includes information on the product name, volume, container type, indications, ingredients, electrolyte content, pH, osmolarity, storage conditions, and expiration dating. It is helpful for those seeking detailed information about EXTRANEAL for Continuous Ambulatory Peritoneal Dialysis (CAPD) therapy.*

This text provides information about an imported product from Singapore called Cortainer, which comes with a closure system measuring 5'. It describes the components of the product, including frangible seals, clamps, a pull ring, and connector covers. The product is designed with features like green and blue frangible seals, online clamps on drain and infusion lines, and deeply recessed connector covers. It emphasizes that no external clamps are needed.*

The text contains information about Baxter's peritoneal dialysis solution called EXTRANEAL. The solution contains Icodextrin and various components such as sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. It is specified for intraperitoneal administration only and should not be used intravenously. The solution is sterile and nonpyrogenic and should be stored below 30°C. It advises users to inspect the inner bag for leaks before use and instructs to discard if any are found. The solution should be used as directed by a physician. The text also mentions product registration information for different countries such as Thailand, Hong Kong, Indonesia, and Malaysia, as well as trademarks associated with Baxter International Inc.*

This text contains information related to a product or item. It includes various codes such as FNBA984SG, ULTRABAG MAL 06021264AZ, MWW FW0236871, and a LOT number S24A12345 with an expiration date of 12.12.2024. It seems to be a list of product identifiers, possibly from different manufacturers or suppliers.*