Product Images Sterile Water

Description: The text provides important information from Baxter Healthcare Corporation regarding the temporary importation of Sterile Water for Injection and 70% Dextrose Injection from Canada to address drug shortages in the United States. Baxter is coordinating with the U.S. Food and Drug Administration (FDA) for this initiative, as no other entity is authorized to import or distribute these specific products. Healthcare professionals are advised to read the provided letters thoroughly for product-specific details.*

This text provides details about bags of Sterile Water for Injection USP and 70% Dextrose Injection USP in different sizes along with their product codes. It highlights the importance of visually inspecting the bags for particulate matter and leaks before use to ensure sterility. It also mentions the need to use a new bag if particulates are visible or if the bag has a leak. Additionally, it states that the imported products are not meant for direct patient administration and recommends checking compatibility of additives and stability when compounding with these products.*

The text provides important information regarding the differences between imported medical products and FDA-approved products in the United States. It discusses issues such as compatibility of administration ports, barcode scanning systems, and labeling discrepancies. It notes that alternative procedures may be needed to ensure the correct product is being used and administered. Additionally, it highlights specific differences in labeling for Sterile Water for Injection USP and 70% Dextrose for Injection USP. The text also mentions the availability of these products by prescription only in the U.S. and the absence of the "Rx only" statement on imported product labeling. It concludes by referring to product comparison tables detailing key disparities in labeling between FDA-approved and imported medical products.*

The text contains information on how to report adverse events or product quality issues related to imported products. It includes contact information for reporting to Baxter, the FDA's MedWatch Adverse Event Reporting program, and Baxter Product Surveillance. Additionally, it provides instructions on completing and submitting reports online, by regular mail, or by fax. It also encourages referring to the FDA-approved prescribing information for each drug product.*

This text provides contact information for Baxter Healthcare Corporation regarding the use and ordering of 70% Dextrose Injection USP. For inquiries about imported products or more information, contact Baxter's Medical Information Service at 1-800-933-0303. To place an order, reach out to Baxter's Center for Service at 1-888-229-0001. The letter is signed by Lee Ann Schuette, the Vice President of Global and US Marketing for IV solutions, Clinical Nutrition, and Pharmacy Tools at Baxter Healthcare Corporation. Baxter and Viaflex are trademarks of Baxter International Inc.*

This is a product comparison table showing key differences between FDA-approved Sterile Water for Injection USP and imported Sterile Water for Injection USP from Canada. The table compares the product name, label volume, languages available, active ingredients, and additional information like osmolarity. The FDA-approved product comes in a 1,000 mL volume and is in English, while the imported product comes in 2,000 mL and 5,000 mL volumes and is available in English and French. Both products are indicated for use in aseptic preparation of parenteral admixtures. The active ingredient in both is Sterile Water Injection USP. Additional information provided includes the osmolarity of the products.*

This text provides instructions for storing medication and details about the container type (VIAFLEX PVC) and its administration port. The medication should be stored at room temperature (25°C/77°F) and protected from freezing. The container features an administration port protected by a blue-colored pull-off port protector.*

This is a comparison table showing label images and details of two products - FDA approved Sterile Water for Injection USP and an imported product from Canada. The labels of both products are described in terms of color and barcode presence. The text includes important information related to the products such as usage instructions, precautions, and storage guidelines. The content also mentions details specific to the imported product, including dosage administration directions and cautionary notes. Additionally, it provides information about the manufacturer of the imported product - Baxter Corporation.*

This is a comparison of key differences between an FDA-approved and imported 70% Dextrose Injection USP. The FDA-approved product is labeled as "70% Dextrase Injection USP" with a label volume of 2,000 mL, while the imported product from Canada is also labeled as "70% Dextrase Injection USP" but with a label volume of 3,000 mL. The indications for use include being a source of calories when mixed with amino acids or other compatible IV fluids for patients requiring parenteral nutrition. The active ingredient in the FDA-approved product is "700 g Dextrose Hydrous USP per 1,000 mL", whereas the imported product contains "700 g Dextrase Hydrous USP per 1,000 mL". The total content of the active ingredient in the FDA-approved product is "1,400 g of dextrose per bag", while the imported product contains "2,100 g of dextrose per bag."*

This text provides detailed information about FDA-approved and imported 70% Dextrose USP products. It includes descriptions of the products, such as their label colors and usage instructions. The text also mentions the content amount, storage instructions, and cautionary information. Additionally, it lists the prescriptive information available and mentions trademarks related to the products.*

This is a description of JB0304 1000 mL Sterile Water for Injection USP. It is a pharmacy bulk package for sterile water not meant for direct infusion. The package is for single puncture, multiple dispensing, and any unused portion should be discarded. It does not contain more than 25 mL of aluminum and does not include any antimicrobial agents or other substances. It must be stored between 15°C to 25°C and is designated as nonpyrogenic sterile. The instructions caution to squeeze and inspect the bag, not to be used in series connections, and to consult the directions for use. This sterile water is hypotonic and only to be admixed. The dosage information is available upon request. The container is a Viaflex PVC container from Baxter Corporation.*

This appears to be a label from a pharmacy. It includes information such as the product code "JB_03,04", volume "100 mL", storage temperature range "5°C-25°C", and usage instructions for USP water. Additionally, the label mentions "Pharmacy Bulk", indicating it may be related to pharmaceutical or medical supplies.*