wilate® (human VWF/FVIII)

Ireland

Summary of Product Characteristics wilate®

Product Information Leaflet wilate®

Republic of Ireland: Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the HPRA website at www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

UK/P/IRW/C/V2 August 2020

This site is intended for Ireland healthcare professionals and may contain promotional information.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Octapharma in the United Kingdom by telephoning 1890 920 522.

Product Information

Summary of Product Characteristics wilate®

Therapeutic Indications

Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated.

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency).

Shelf Life & Storage

Shelf life three years (+2° to +8°C).

The stability of the reconstituted solution has been demonstrated for four hours at room temperature (maximum +25°C). Nevertheless, to avoid microbial contamination, the reconstituted solution should be used immediately

Vials Sizes

Our licensed vial sizes are listed below:

  • 500 IU VWF/500 IU FVIII

  • 1000 IU VWF/1000 IU FVIII

For questions about availability please contact customer services.

UK/P/IRWHCP/C/V3 August 2020