SEMGLEE Solution for injection Ref.[27592] Active ingredients: Insulin glargine

SEMGLEE contains insulin glargine as a sterile solution for subcutaneous use. Insulin glargine is a recombinant human long-acting insulin analog [see Clinical Pharmacology (12)]. SEMGLEE is produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris, as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21^A-Gly-30^Ba-L-Arg-30^Bb-L-Arg-human insulin and has the empirical formula C₂₆₇H₄₀₄N₇₂O₇₈S₆ and a molecular weight of 6063.

Insulin glargine has the following structural formula:

SEMGLEE consists of insulin glargine dissolved in a clear, colorless, sterile solution. Each milliliter contains 100 units (3.64 mg) insulin glargine.

The 10 mL SEMGLEE vial contains the following inactive ingredients per mL: 30 mcg zinc, 20 mg glycerol 85%, 20 mcg polysorbate-20, 2.7 mg m-Cresol and water for injection.

The 3 mL SEMGLEE prefilled pen contains the following inactive ingredients per mL: 30 mcg zinc, 20 mg glycerol 85%, 2.7 mg m-Cresol and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. SEMGLEE has a pH of approximately 4.