ABSTRACT

Description: Saizen is a human growth hormone (hGH) produced by recombinant DNA technology in an engineered mammalian cell line. The 191-amino acid, 22.125kDa protein displays an amino acid sequence identical to the pituitary-derived endogenous growth hormone. The product is presented in freeze-dried format and is generally available in vials containing 5.0 or 8.8 mg active ingredient. The diluent provided is bacteriostatic water for injection (WFI containing 0.9% benzyl alcohol). After reconstitution, the product, which displays a pH of 6.5 to 8.5, is administered subcutaneously or intramuscularly. The active ingredient in Saizen is identical to that in Serono’s other hGH product, Serostim.