Glucose
Product Images NDC 0338-9787

The provided text contains important prescribing information from Baxter Healthcare Corporation regarding the temporary importation of 50% Glucose Injection and 70% Glucose Injection from the United Kingdom to address drug shortages. The products will be imported from Baxter's manufacturing facility in Thetford, United Kingdom, with coordination from the U.S. Food and Drug Administration (FDA). Please note that these products have not been approved by the FDA for use. During this temporary period, Baxter will be the only authorized entity to import and distribute these products in the United States. Additional letters may be provided for other imported products, and it is recommended to review each letter thoroughly for product-specific information.*

This text provides information about glucose injection products with different caloric content and NDC codes. It emphasizes that imported Glucose Injection products are not directly interchangeable with FDA-approved Dextrose Injection USP. The caloric content of 70% Glucose Injection is 2,800 kcal/L, while the caloric content of 70% Dextrose Injection USP is 2,380 kcal/L, indicating a difference in energy content per mL. Adjustments in protocols, order entry, and compounding systems may be necessary when using these products.*

The text provides guidance on inspecting bags for particulate matter, leaks, and defects before use, especially for parenteral drug products. It emphasizes the importance of container integrity for sterility. It also mentions using a new bag if particulates are visible or if there is a leak. Additionally, it mentions checking compatibility and stability when compounding products and highlights that the administration port system is compatible with Baxter sets in the United States. It suggests manually inputting product information for products without barcodes to prevent incorrect information in scanning systems. Lastly, it mentions the availability of 70% Dextrose for Injection USP by prescription only in the U.S., contrasting with the labeling of imported products 50% Glucose Injection and 70% Glucose Injection.*

This text provides a comparison of key differences in labeling between FDA-approved 70% Dextrose Injection USP and imported 70% Glucose Injection and 50% Injection products. The text mentions a product comparison table and label images for reference. It also suggests consulting the UK prescribing information for pharmaceutical calculations using concentrated Glucose Injections and referring to FDA-approved prescribing information for 70% Dextrose Injection USP.*

This text provides information on how to report adverse events or product quality issues related to imported products from Baxter Healthcare Corporation. It includes contact numbers for reporting adverse events to Baxter or the FDA's MedWatch program, as well as guidance on reporting product quality issues through Baxter Product Surveillance. Additionally, contact details for Baxter's Medical Information Service and Center for Service are provided for any further inquiries or to place an order.*

This text provides a comparison between FDA-approved 70% Dextrose Injection USP and imported Glucose Injections from the UK (70% and 50%). It covers different aspects such as product names, label volume, indications, active ingredients, caloric content, additional information, storage conditions, container type, and administration port closures. The information includes the intended uses of each product, their ingredients, caloric content, osmolarity, storage conditions, and container types. It also specifies the type of administration port closures for each product.*

This text provides detailed information about three different glucose injection products: FDA-approved 70% Dextrose Injection USP, imported 70% Glucose Injection, and imported 50% Glucose Injection. It includes descriptions of the products, label colors, lot numbers, barcode information, dosages, administration instructions, storage guidelines, safety precautions, and more. The text also mentions the manufacturers of the products and contains important details about usage and disposal.*

This is a product label for Baxter Glucose 50% w/v solution intended for infusion under medical supervision. The solution needs to be diluted before use and should not be administered directly into veins. It is essential to check compatibility with other infusion components before use. The product should be stored below 25°C, and once the container is opened, it should be used as a single dose only. Proper disposal of any unused portion is required, and caution is advised not to administer simultaneously with blood or blood components using the same infusion equipment. Contact Baxter Healthcare Ltd for further information.*

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This is a description of a 500 ml Baxter Glucose 70% w/v concentrate for solution for infusion contained in a Viaflex container, which is free from bacterial endotoxins. It includes instructions for dilution before use, not for direct intravenous infusion, for medical supervision, aseptic conditions, compatibility check with other components, storage temperature limitation, clarity and container integrity check before use, single-use only instructions, guidance on disposal of unused portions and associated materials, caution against administering simultaneously with blood, discontinuing infusion in case of adverse reactions. The text also includes the manufacturer's contact information and lot expiry details.*

This text provides information about a product from Baxter Healthcare Ltd located in the UK. It includes the product code (FKB0273B), the address of the company, a lot number (EXP), and a lot code (BXP).*