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Levemir

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LEVEMIR®
(insulin detemir [rDNA origin]) Injection

DRUG DESCRIPTION

LEVEMIR® (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as an injection. Insulin detemir is a long-acting basal insulin analog, with up to 24 hours duration of action, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.

Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C267H402O76N64S6 and a molecular weight of 5916.9. It has the following structure:

LEVEMIR®  (insulin detemir [rDNA origin] injection) Structural Formula Illustration

LEVEMIR is a clear, colorless, aqueous, neutral sterile solution. Each milliliter of LEVEMIR contains 100 U (14.2 mg/mL) insulin detemir.

Each milliliter of LEVEMIR 10 mL Vial contains the inactive ingredients 65.4 mcg zinc, 2.06 mg m-cresol, 30.0 mg mannitol, 1.80 mg phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride, and water for injection. Each milliliter of LEVEMIR 3 mL PenFill® cartridge, FlexPen™ and InnoLet® contains the inactive ingredients 65.4 mcg zinc, 2.06 mg m-cresol, 16.0 mg glycerol, 1.80 mg phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride, and water for injection.

Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. LEVEMIR has a pH of approximately 7.4.

Brand Name: Levemir
Generic Name: Insulin Detemir
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