Wilate



Wilate

Product Specs Wilate
Manufacturer Name Octapharma
Indications Children and adults with von Willebrand disease for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes. Wilate is indicated for routine prophylaxis in children 6 years of age and older and adults with von Willebrand disease

    • 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


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