药物信息为Serostim [somatropin (rDNA origin) for injection] (EMD Serono, Inc.): DESCRIPTION

Serostim^® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technology. Serostim^® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary GH. Serostim^® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. Serostim^® is secreted directly through the cell membrane into the cell-culture medium for collection and purification.

Serostim^® is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.

Serostim^® is available in 5 mg and 6 mg vials for single dose administration. Serostim^® is also available in 4 mg and 8.8 mg vials for multi-dose administration. Each 4 mg vial contains 4.0 mg (approximately 12 IU) somatropin, 27.3 mg sucrose, 0.9 mg phosphoric acid. Each 5 mg vial contains 5.0 mg (approximately 15 IU) somatropin, 34.2 mg sucrose and 1.2 mg phosphoric acid. Each 6 mg vial contains 6.0 mg (approximately 18 IU) somatropin, 41.0 mg sucrose and 1.4 mg phosphoric acid. Each 8.8 mg vial contains 8.8 mg (approximately 26.4 IU) somatropin, 60.19 mg sucrose and 2.05 mg phosphoric acid. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution with Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol).