ABSTRACT

Description: Norditropin is a highly purified preparation of human growth hormone (hGH) produced by recombinant DNA technology. The 191-amino acid, single-chain, 22, 124-Da polypeptide is identical to native hGH. It is available both in freezedried and liquid formulations. The lyophilized format is available in various final product configurations, either in vials containing 4 or 8 mg active ingredient or in cartridges for use in conjunction with a pen-like autoinjector administration device (the NordiPen). The diluent provided is usually water for injection (WFI) containing 1.5% benzyl alcohol as a preservative, although the product can be reconstituted in WFI alone for patients who are allergic to benzyl alcohol. The liquid formulation of the product is referred to as Norditropin SimpleXx. The product is stored at 2 to 8°C and is normally administered at concentrations of 2-4 mg active/ml subcutaneously.