Tretten

Product Specs	Tretten
Manufacturer Name	Novo Nordisk
Indications	For routine prophylaxis of bleeding in patients with congenital factor XIII Asubunit deficiency
Contraindications	Not for use in patients with congenital factor XIII B-subunit Deficiency. Hypersensitivity to the active substance or to any of the excipients.
Viral Safety Process	Chromatography steps, including hydrophobic interaction and ion exchange chromatograph.
Product Half-Life	Adults 5.1 (2.6) days Children 7.1 (1.9) days
Manufacturing Method	Manufactured 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 Volume	2000 – 3125 IU/3.2 mL