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Genentech A Member of the Roche Group
IMPORTANT PRESCRIBING INFORMATION
Subject: Temporary Importation of Sterile Water for Injection (SWFI) Ampules to Address Supply Shortage
Dear Health Care Provider:
In order to address ongoing shortages of Sterile Water for Injection (SWFI), Genentech, Inc. (A Member of the Roche Group) is coordinating with the U.S. FDA Drug Shortage Staff to make available 5 mL SWFI ampules manufactured by Roche's SWFI supplier in Germany.
At this time, no other entity except Genentech is authorized by the FDA to import or distribute Sterile Water for Injection, USP, 5 mL Single-Dose Ampule in the U.S. The FDA has not approved Genentech's Sterile Water for Injection, USP, 5 mL Single-Dose Ampule in the United States.
SWFI presentations most commonly available in the U.S. are in vials. Genentech is temporarily importing SWFI presentations from Germany in 5 mL glass ampules. Pictures of the 5 mL SWFI ampule and label are enclosed at the end of this letter.
Effective immediately, Genentech will offer free of charge a limited supply on an allocation plan of the following:
The dosage and administration instructions provided in the FDA package inserts of the drug being reconstituted should be followed when using the 5 mL SWFI ampules. It is also important to note the following:
To place an order for 5 mL SWFI ampules, please contact Genentech Customer Service by calling 1-800-551-2231.
If you have any medical questions about the information contained in this letter or the use of the imported 5 mL SWFI ampules, please contact Genentech Medical Communications at 1-800-821-8590.
To report a product complaint concerning the imported 5 mL SWFI ampules, please contact Genentech Product Quality at 1-800-334-0290.
To report an adverse event concerning the imported 5 mL SWFI ampules, please contact Genentech at 1-888-835-2555.
Adverse events or quality problems experienced with the use of the 5 mL SWFI ampules may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
Lance Baldo, M.D., Head of U.S. Medical Affairs
Reference: American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:145–66.
|Product Name and Description||Size||NDC||Store at|
|Sterile Water for Injection, USP Sterile, clear and colorless liquid||5 mL glass ampule||50242-001-05||20°C to 25°C (68°F to 77°F) See USP Controlled Room Temperature|
|Product Picture and Label|
Sterile Water for Injection, USP
FOR DRUG DILUENT USE ONLY
5 mL Single-Dose Ampule
NOT FOR SALE
Rx only Genentech
Rx only Sterile Caution: Must be diluted prior to use.
Green Glo (Lissamine Green)
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