Figure 1 (Skysona 01)
Skysona Suspension
Product Images NDC 73554-2111
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Skysona (NDC 73554-2111). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Genetix Biotherapeutics Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Figure 2 (Skysona 02)
This appears to be a survival probability chart for subjects undergoing treatment for some medical condition. The chart appears to show the survival probability over a certain number of months from treatment, with "Subjects at Risk" depicted in a vertical column. Unfortunately, without additional context or a clear indication of what medical condition this pertains to, it is difficult to provide a more specific description.*
Principal Display Panel (20 mL Bag Patient Identifier Label)
This is a description of a medicinal product named "elivaldogene autotemcel" with a brand name "skysona". It is a suspension for V infusion in a 20mL containing cells. The dosage of cells per mL ranges from 4 to 30 x 106 CD34+ cells/mL. The patient needs to confirm their identifiers such as last name, first name, date of birth, bbb patient ID, Col ID, LOT, EXP before using this medication. The remaining text includes codes and product identification.*
Principal Display Panel (20 mL Bag Label)
This is a suspension for IV infusion with genetically modified autologous hematopoietic stem cells suspended in cryopreservation solution. It is available in 20 mL containing 4 to 30 x 10° cells/mL (3.6 to 30 x 10°CD34+ cells/mL) and is for autologous use only. This product is not evaluated for infectious substances and should not be irradiated, and an in-line blood filter or infusion pump should not be used. See the full prescribing information for dosage and administration. The Lot Information Sheet should be consulted to find the number of infusion bags and CD34+ cells per kg for the individual patient. The product is manufactured for bluebird bio, Inc. in Somerville, MA 02145.*
Principal Display Panel (20 mL Bag Cassette Label)
Skysona is a suspension for IV infusion containing autologous hematopoietic stem cells transduced with Lenti-D lentiviral vector suspended in cryopreservation solution containing 5% DMSO. It is for autologous use only and for intravenous use only. This medicine contains genetically modified cells and is not evaluated for infectious substances. It should be kept in the vapor phase of liquid nitrogen at < -140°C. See full prescribing information for dosage and administration. It's not available to determine Last Name, First Name, DOB, etc.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
