Label Changes for:
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]) Humalog Mix 50/50 (50% insulin lispro protamine suspension/50 insulin lispro injection [rDNA origin])
October 2011
Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011
Humalog (insulin lispro injection)
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin])
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50 insulin lispro injection [rDNA origin])
PATIENT PACKAGE INSERT
[Instructions for Use Leaflet, or Users Manual]
- added......warning against the sharing of insulin pens and needles
