Saizen Description

Solution for injection: Saizen Liquid 6 mg solution for injection: Each cartridge contains 1.03 ml solution (6 mg somatropin*).
Saizen Liquid 12 mg & 20 mg for injection: Each cartridge contains 1.50 ml solution (12 mg somatropin*) or 2.50 ml solution (20 mg somatropin*).
*recombinant human growth hormone, produced by recombinant DNA technology in mammalian cells.
pH of 5.6-6.6 and osmolality 250-450 mOsm/kg.
Powder for injection 3.33 mg vial: Each vial of Saizen 3.33 mg contains somatropin* (recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells.
After reconstitution with the enclosed solvent, each vial shall contain ≥ 0.67 mg of Saizen/ml.
Appearance of the solvent: clear colourless solution.
The pH of the reconstituted solution is 7.4-8.5.
Powder for injection 8 mg click.easy vial: Each vial of Saizen 8 mg click.easy contains 8 mg somatropin* (recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells.
Reconstitution with the contents of the bacteriostatic solvent cartridge gives a concentration of 5.83 mg/ml.
The pH of the reconstituted solution is 6.5-8.5.
Excipients/Inactive Ingredients: Solution for injection: Sucrose, Poloxamer 188, Phenol, Citric Acid (for pH adjustment), Sodium Hydroxide (for pH adjustment), Water for Injection.
Powder for injection 3.33 mg vial: Powder: Mannitol, Disodium phosphate dihydrate, Sodium dihydrogen phosphate monohydrate.
Solvent: Sodium chloride (0.9% w/v) and benzyl alcohol (0.9% w/v, as preservative) solution for injection.
Powder for injection 8 mg click.easy vial: Powder: Sucrose, Phosphoric acid (for pH-adjustment), Sodium Hydroxide (for pH-adjustment).
Solvent: Metacresol (as preservative 0.3% w/v) solution in water for injection.