Saizen Lyophilized Powder For Injection, Brand Name : Somatropin

® [somatropin (rDNA origin) for injection] is a human growth hormone produced byrecombinant DNA technology. ® has 191 amino acid residues and a molecular weight of22,125 daltons. Its amino acid sequence and structure are identical to the dominant form ofhuman pituitary growth hormone. ® is produced by a mammalian cell line (mouse C127)that has been modified by the addition of the human growth hormone gene. ®, with thecorrect three-dimensional configuration, is secreted directly through the cell membrane into thecell-culture medium for collection and purification.® is a highly purified preparation. Biological potency is determined by measuring theincrease in body weight induced in hypophysectomized rats.® is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous orintramuscular injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9%Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.® is available in 5 mg and 8.8 mg vials. The quantitative composition per vial is:5 mg vial:Each vial contains 5 mg somatropin, 34.2 mg sucrose and 1.16 mg O-phosphoric acid. The pH isadjusted with sodium hydroxide or O-phosphoric acid.8.8 mg vial:Each vial contains 8.8 mg somatropin, 60.2 mg sucrose and 2.05 mg O-phosphoric acid. The pHis adjusted with sodium hydroxide or O-phosphoric acid.The diluent is Bacteriostatic Water for Injection, USP containing 0.9% Benzyl Alcohol added asan antimicrobial preservative.® is also available in the click.easy® reconstitution device. The quantitative compositionper vial contained in the click.easy® reconstitution device is:8.8 mg vial contained in the click.easy® device:Each vial contains 8.8 mg somatropin, 60.2 mg sucrose and 2.05 mg O-phosphoric acid. The pHis adjusted with sodium hydroxide or O-phosphoric acid.4 mg vial contained in the click.easy® device:Each vial contains 4 mg somatropin, 27.3 mg sucrose and 0.9 mg O-phosphoric acid. The pH isadjusted with sodium hydroxide or O-phosphoric acid.The diluent in the click.easy® device contains 0.3% (w/v) metacresol in Sterile Water forInjection added as an antimicrobial preservative. The reconstituted solution has a pH of 6.5 to8.5.