Track topics on Twitter Track topics that are important to you
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)
Fluorescein Sodium Ophthalmic Strips, USP
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions. Sterile...
Patients who are diagnosed with acute appendicitis consented and then randomized into two arms of the trial. In one arm, patients receive irrigation of the abdomen during surgery with norm...
To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbi...
The purpose of this study is to determine the pharmacokinetics and safety of rAHF-PFM reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstitu...
The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to...
The use of sterile water injections (SWI) for the relief of pain in labour is popular amongst midwives in countries such as Sweden and Australia. Anecdotal reports suggest the procedure is used less c...
OBJECTIVE To evaluate the in vitro effect of 20% N-acetylcysteine (NAC) on the viscosity of normal canine bile. ANIMALS Bile samples obtained from 10 adult dogs euthanized for reasons unrelated to bil...
The sterile processing of surgical instruments and equipment is an essential part of surgical operations. Although clean instruments prevent infections, little is known about the departments that cond...
Increased access to sterile syringes has been shown to reduce HIV risk among people who inject drugs (PWID). Where syringe services programs (SSPs) are limited, pharmacies are an important sterile syr...
Acute pancreatitis complicated by walled-off necrosis (WON) is associated with high morbidity and mortality, and if infected, this condition typically necessitates intervention. Clinical outcomes of i...
Alliances Astrazeneca Bioethics Boehringer Clinical Research Organization Collaborations GSK Johnson & Johnson Lilly Merck Mergers and Acquisitions Nexium Novartis Pfizer Roche Sanofi ...
The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...