HUMATROPE

Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of
recombinant DNA origin. Humatrope has 191 amino acid residues and a molecular weight of
about 22,125 daltons. The amino acid sequence of the product is identical to that of human
growth hormone of pituitary origin. Humatrope is synthesized in a strain of Escherichia coli that
has been modified by the addition of the gene for human growth hormone.
Humatrope is a sterile, white, lyophilized powder intended for subcutaneous or intramuscular
administration after reconstitution. Humatrope is a highly purified preparation. 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.
VIAL — Each vial of Humatrope contains 5 mg somatropin (15 IU or 225 nanomoles); 25 mg
mannitol; 5 mg glycine; and 1.13 mg dibasic sodium phosphate. Each vial is supplied in a
combination package with an accompanying 5-mL vial of diluting solution. The diluent contains
Water for Injection with 0.3% Metacresol as a preservative and 1.7% glycerin.
CARTRIDGE — The cartridges of somatropin contain either 6 mg (18 IU), 12 mg (36 IU), or
24 mg (72 IU) of somatropin. The 6, 12, and 24 mg cartridges contain respectively: mannitol 18,
36, and 72 mg; glycine 6, 12, and 24 mg; dibasic sodium phosphate 1.36, 2.72, and 5.43 mg.
Each cartridge is supplied in a combination package with an accompanying syringe containing
approximately 3 mL of diluting solution. The diluent contains Water for Injection;
0.3% Metacresol as a preservative; and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg
cartridges, respectively.
C