9/16/2005

NovoLog Packages Have Orange Band to Reduce Errors

Cheryl A. Thompson

Novo Nordisk Inc. has replaced the blue band on NovoLog vials, prefilled syringes, cartridges, and boxes with an orange band to help prevent mix-ups with NovoLog Mix 70/30 packages, the company recently told pharmacists.

In a "Dear Pharmacist" letter (PDF) dated Aug. 26 and posted online Wednesday at the Food and Drug Administration's MedWatch Web site, the company said it had introduced color-branded labeling for insulin aspart products "to help prevent dispensing errors."

NovoLog contains insulin aspart, an insulin analog that rapidly lowers a recipient's blood glucose concentration but whose effect lasts only three to five hours. NovoLog Mix 70/30 is 70 percent insulin aspart protamine suspension and 30 percent insulin aspart, a mixture that, according to its official labeling, lowers the blood glucose concentration long enough to cover two meals or a meal and snack.

Hyperglycemia or hypoglycemia could develop in patients who receive the incorrect insulin aspart product and use it, the company said.

The NovoLog Mix 70/30 vials, prefilled syringes, cartridges, and boxes retain the blue band that has marked the company's line of insulin aspart products since their entry onto the U.S. market in 2000.

Novo Nordisk in June 2003 started submitting paperwork to obtain the government's approval to institute color-branded labeling on insulin aspart products, according to a public document.

The Food and Drug Administration approved the change in October 2004.


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