SPL Set ID: a774e1ae-3997-49ee-8b0e-99a2b315d409

Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9 ): Table 9: Contents of HUMATROPE Component Cartridge 6 mg (gold) 12 mg (teal) 24 mg (purple) Somatropin 6 mg 12 mg 24 mg Dibasic sodium phosphate 1.36 mg 2.72 mg 5.43 mg Glycine 6 mg 12 mg 24 mg Mannitol 18 mg 36 mg 72 mg Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively.