SPL Set ID: 85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886

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 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. ZOMACTON (somatropin) for injection is a sterile, white lyophilized powder, intended for subcutaneous injection after reconstitution with the accompanying diluent. ZOMACTON 5 mg single-patient-use vial contains 5 mg of somatropin and mannitol (30 mg). Each 5 mg vial is co-packaged with a 5 mL vial of diluent containing Bacteriostatic Sodium Chloride Injection, USP, with 0.9% benzyl alcohol as a preservative, and Water for Injection, USP. ZOMACTON 10 mg single-patient-use vial contains 10 mg of somatropin, mannitol (10 mg), dibasic sodium phosphate (1.415 mg), and monobasic sodium phosphate (0.608 mg). Each 10 mg vial is co-packaged with a 1 mL syringe of diluent containing Bacteriostatic Water for Injection, USP with 0.33% metacresol as a preservative. Reconstituted solutions have a pH in the range of 7 to 9.