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	Refrigerated at 2°C to 8°C (36°F to 46°F) prior to reconstitution, or room temperate not to exceed 25°C (77°F) for up to 3 hours after reconstitution. Do not freeze.
Shelf Life	Stable until the expiration date on the carton and vial label
Nominal Vial Size & Diluent Volume	2000 – 3125 IU/3.2 mL