Potentially Low Fill Vials of GIAPREZA® (Angiotensin II) 2.5mg/ml concentrate for solution for infusion: Important information regarding instructions for use.

Summary:

• PAION Deutschland GmbH has been notified by the Supplier of GIAPREZA® (Giapreza 2.5 mg/ml concentrate for solution for infusion ) with 2.5mg Angiotensin II /vial) that several hospitals in the United States, have identified low fill vials of GIAPREZA® (Angiotensin II) Product Lot 2457-116 corresponding to Product Batches: 23GPZ001, 23GPZ002, 23GPZ003, 23GPZ004, 23GPZ005, 23GPZ006 and 23GPZ008 in Europe, one or more of which have been supplied to your health institution.
• It has been reported that when the contents of a vial are withdrawn into a syringe the volume is less than the 1 mL volume defined in the Product Information.
• We have determined that patient safety is not impacted since the product is dosed as “titrate to effect”.
• Should you identify a vial with less than 1 ml volume, 
  • preferably discard the vial and use another new vial or 
  • alternatively dilute the lower withdrawn volume from the 2.5 mg/mL solution using a matching volume of normal saline (0.9% sodium chloride) to achieve the desired concentration of 5,000 ng/ml or 10,000 ng/ml.
• Out of an abundance of caution, PAION Deutschland GmbH (PAION), is notifying health care providers and will replace any impacted vials found to have less than 1 mL volume, if requested (For product replacement, see Annex 1 below for instructions). 
• Please be aware that low fill vial have not been reported in EU so far.