Zanosar Powder, For Solution
Product Images NDC 68118-100

This document appears to be the label for a medicinal product named Zanosar, manufactured by VALDEPHARM SA. The label includes important information such as the product number, client information, format, and usage instructions. The label also contains a message for the client, encouraging them to carefully review and validate the included elements before proceeding with production. Overall, this label aims to provide important information about the product and ensure that the client understands the associated risks and usage instructions.*

This is a description of a packaging document for Zanosar, a cytotoxic medication manufactured by Valdepharm. The packaging is done by Cartonex and the product is 1g in strength. The product belongs to the Streptozocin family of medications and is meant to be stored under special storage conditions, like refrigeration. The document asks for the product to be handled by trained and qualified personnel only. The document also provides details for the active ingredient and excipients used in the medication. Finally, the document provides details around responsible disposal of any waste material resulting from the use of the medication.*

Esteve Pharmaceuticals S.A.S is coordinating with the FDA to temporarily import non-FDA-approved Zanosar (Streptozocin) to address critical shortages in the United States. The imported product is marketed in the European Union and the United Kingdom and is labeled in English. Dosage schedules requirements for the imported product are the same as the FDA-approved Zanosar, and it is important to note that the two products have differences as illustrated by a comparison table. Storage requirements for the imported product is 2°C to 8°C in a refrigerator. The therapeutic indication for Zanosar is treatment for patients with advanced pancreatic carcinoma.*

This is a comparison of FDA-approved Zanosar and an unapproved imported product, indicating important differences in container, label, shelf life, indication, and administration. Zanosar is approved for the treatment of adult patients with inoperable, advanced, or metastatic, progressive and/or symptomatic, well-differentiated, G1 or G2 neuroendocrine tumors of pancreatic origin, in combination with 5-Fluorouracil, while the imported product is indicated for the systemic treatment of islet cell carcinoma of the pancreas. The text describes the administration process and the need for caution and appropriate protection measures due to the vesicant nature of the products. The contact details of Esteve Pharmaceuticals SAS are also provided.*

The text provides a comparison of instructions for reconstituting and storing Zanosar between the FDA-approved US product and an unapproved imported product. It also discloses differences in labeling, serialization, and barcode registration. The text also provides contact information for the pharmaceutical company Esteve Pharmaceuticals SAS to report quality issues or adverse events associated with non-FDA approved Zanosar.*

This text provides information on reporting adverse events or quality problems associated with a certain product to the FDA's MedWatch Adverse Event Reporting Program. It includes instructions on how to submit the report online, by regular mail, or by fax. The signature of an authorized person is also included. The rest of the text appears to be a signature block with contact information for Eugénie Koubbi, Chief Pharmaceuticals Officer of Esteve Pharmaceuticals SAS.*