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Tretten

Product SpecsDescription
Manufacturer NameNovo Nordisk
IndicationsFor routine prophylaxis of bleeding in patients with congenital factor XIII Asubunit deficiency
ContraindicationsNot for use in patients with congenital factor XIII B-subunit Deficiency. Hypersensitivity to the active substance or to any of the excipients.
Viral Safety ProcessChromatography steps, including hydrophobic interaction and ion exchange chromatograph.
Product Half-LifeAdults 5.1 (2.6) days
Children 7.1 (1.9) days
Manufacturing MethodManufactured as an intracellular, soluble protein in yeast. No human or animal derived products are used in the manufacturing process.
Storage Requirements/Shelf Life
  • Refrigerated at 2°C to 8°C (36°F to 46°F) prior to reconstitution.
  • Stable until the expiration date on the label.
  • After reconstitution, store refrigerated or at room temperature not to exceed 25°C (77°F) for up to 3 hours.
  • Do not freeze.
Nominal Vial Size & Diluent Volume2000 – 3125 IU/3.2 mL