Rough shaking of the solution must be avoided. NHS -IL12 drug product will be administered undiluted (1500mcg/mL) for doses ≥ 300mcg. However, for doses below 300 µ g, NHS -IL12 drug product must be diluted with 0.9% saline solution (sodium chloride injection). Doses 100 to 299 mcg will be administered as a 500mcg/mL solution and doses 30 to 99 mcg will be administered as a 150 mcg/mL solution. Detailed information on medical devices to be used for the preparation and administration of NHS -IL12 will be provided in the Investigator Brochure. Any unused portion of the solution should be discarded in biohazard waste disposal with final disposal by accepted local and national standards of incineration. 14.3.4 Stability and Storage NHS -IL12 drug product must be stored at 2°C to 8°C until use, with a temperature log maintained daily. All medication boxes supplied to the study site must be stored carefully, safely, and separately from other drugs. The chemical and physical in -use stability of NHS -IL12 diluted and undiluted solution in syringes has been demonstrated for 24 hours at 25°C. However, to reduce the risk of microbial contamination, the solution should be used immediately unless medication preparation has been performed in controlled and validated aseptic conditions. Rough shaking of the solution must be avoided. 14.3.5 Administration P rocedures NHS -IL12 is administered subcutaneously. It can be given in the arm , leg or abdomen. Where feasible it should be given in a different limb than the vaccine. 14.3.6 Incompatibilities Not available. 91 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 15 REFERENCES 1. Viens LJ, Henley SJ, Watson M, Markowitz LE, Thomas CC, Thompson TD, Razzaghi H, Saraiya M: Human Papillomavirus -Associated Cancers - United States, 2008- 2012. MMWR Morb Mortal Wkly Rep 2016, 65(26):661-666.