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Saizen® is a human growth hormone produced by recombinant DNA technology. Saizen® 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 growth hormone. Saizen® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene.

Saizen® is a sterile, non pyrogenic, white, lyophilized powder intended for subcutaneous 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.

Vials

Saizen® is available in 5 mg and 8.8 mg vials. The quantitative composition per vial is:

5 mg vial

Each vial contains 5.0 mg somatropin, 34.2 mg sucrose and 1.16 mg O-phosphoric acid. The pH is adjusted 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 pH is adjusted with sodium hydroxide or O-phosphoric acid.

Diluent

The diluent is Bacteriostatic Water for Injection, USP containing 0.9% Benzyl Alcohol added as an antimicrobial preservative.

Click.easy® reconstitution device

Saizen® is also available in the click.easy® reconstitution device. The quantitative composition per 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 pH is adjusted with sodium hydroxide or O-phosphoric acid.

Diluent

The diluent contained in click.easy® device is 0.3% (w/v) metacresol in Sterile Water for Injection added as an antimicrobial preservative. The reconstituted solution has a pH of 6.5 to 8.5.

Last reviewed on RxList: 4/16/2012
This monograph has been modified to include the generic and brand name in many instances.