a1988: compassionate use initiated in the United States; 1999: FDA approval received for CHwI.30
bIncludes bleeding episodes, major and minor surgical procedures, traumatic injuries, and prophylaxis regimens.
cSuccess was defined differently in each study.
dPrior to reconstitution, store NovoSeven® RT powder and histidine diluent between 36-77˚F. After reconstitution, store NovoSeven® RT either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven® RT or store in syringes.
eIn clinical trials and registries used to support licensure and in postmarketing surveillance, the overall rate of thrombosis was 0.17% of 12,288 bleeding and surgical episodes.29
fData based on postmarketing retrospective safety assessment of clinical trials and registries.