Wilate

Product Specs	Description
Manufacturer Name	Octapharma
Indications	Children and adults with von Willebrand disease for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Adolescents and adults with hemophilia A for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding
Contraindications	Patients with known hypersensitivity reactions, including anaphylactic or severe system reactions, to human plasma-derived product, any ingredient in the formulation, or components of the container.
Ratio of VWF: RCO to FVIII	1:1
Viral Safety Process	Ion-exchange chromatography; solvent/detergent treatment, and terminal dry-heat treatment
Product Half-Life	Adolescents – Mean: 11.41 (range: 9.37-14.57) Adults – Mean: 10.64 (range: 6.30-15.43)
Product Recovery Percentage	Adolescents – 1.66% per IU/kg Adults – 2.27% per IU/kg
Manufacturing Methods	Plasma Derived
Storage Requirements/Shelf Life	Store for up to 36 months from the date of manufacture at +2°C to +8°C (36°F to 46°F) in the original package to protect from light. May be stored for a period of up to 6 months at room temperature (maximum of +25°C or 77°F). Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature, or the expiration date on the label, whichever is earliest. Do not freeze. Reconstitute directly before injection. Use the solution immediately after reconstitution.
Nominal Vial Size & Diluent Volume	500 IU VWF:RCo, 500 IU FVIII:C/5 mL 1000 IU VWF:RCo, 1000 IU FVIII:C/10 mL