Humatrope - Sky Medicines


Humatrope

Humatropin ® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of recombinant DNA origin. Humatropin 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. Humatropin is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human growth hormone.

Humatropin is a sterile, white, lyophilized powder intended for subcutaneous or intramuscular administration after reconstitution. Humatropin 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 Humatropin 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 mg, 12 mg and 24 mg cartridges contain respectively: mannitol 18 mg, 36 mg, and 72 mg; glycine 6 mg, 12 mg, and 24 mg; dibasic sodium phosphate 1.36 mg, 2.72 mg, 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% gylcerin in the 6 mg, 12 mg, and 24 mg cartridges respectively.
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