Valtropin

DRUG DESCRIPTION

Valtropin (somatropin injection) ® [somatropin (rDNA origin) for injection] is a polypeptide hormone
of recombinant DNA origin. The hormone is produced by recombinant DNA technology
in yeast cells (Saccharomyces cerevisiae). Valtropin (somatropin injection) ® has 191 amino
acid residues and a molecular weight of 22,125 daltons. The amino acid sequence
of the product is identical to that of human growth hormone (hGH) of pituitary
origin.

Valtropin (somatropin injection) ® is a sterile, non-pyrogenic, white to almost white, lyophilized powder intended for subcutaneous injection after reconstitution. Each vial contains 5 mg somatropin (approximately 15 International Units), 10 mg glycine, 45 mg mannitol, 0.22 mg monobasic sodium phosphate, and 2.98 mg dibasic sodium phosphate. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. A pre-filled syringe of 1.5 mL clear solution diluent is provided for reconstitution of the powder. The pre-filled syringe contains 1.5 mL Water for Injection and 0.3% w/v metacresol as an antimicrobial preservative. After reconstitution with 1.5 mL diluent, the solution contains 3.33 mg/mL of somatropin.