Leaflet OPTIVATE 100UI / ml powder and solvent for solution for injection

Indicated for: bleeding; coagulation disorders

Route of administration: injectable

Substance: coagulation factor VIII and von Willebrand factor (coagulation factor)

ATC: B02BD06 (Blood and blood forming organs | Vitamin k and other hemostatics | Blood coagulation factors)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage
Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

The combination of coagulation factor VIII and von Willebrand factor is used in the treatment of hemophilia A and von Willebrand disease, two conditions involving blood clotting disorders. Factor VIII helps form the clot, while von Willebrand factor stabilizes factor VIII and facilitates platelet adhesion at the site of injury.

This combination is administered intravenously under medical supervision, with the dose adjusted according to the severity of the deficiency and the type of bleeding. Treatment can be given prophylactically or as needed, especially before surgeries or in case of trauma.

Side effects may include allergic reactions, fever, headaches, or, rarely, the development of antibodies that can reduce the effectiveness of the treatment. Careful monitoring of the patient is essential to quickly detect any adverse reactions and adjust the treatment if necessary.

Therapy with factor VIII and von Willebrand factor has significantly improved the quality of life for patients with bleeding disorders. Following medical advice and being informed about possible risks contribute to safe and effective treatment.

General data about OPTIVATE 100UI / ml

  • Substance: coagulation factor VIII and von Willebrand factor
  • Date of latest medicines list: 01-12-2020
  • Product code: W67136001
  • Concentration: 100UI / ml
  • Pharmaceutical form: powder and solvent for solution for injection
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: BIO PRODUCTS LABORATORY LIMITED - MAREA BRITANIE
  • Holder: BPL BIOPRODUCTS LABORATORY GMBH - GERMANIA
  • Number: 12085/2019/01
  • Shelf life: 3 years

Concentrations available for coagulation factor VIII and von Willebrand factor

  • 1000UI
  • 1000UI FVW/1000UI FVIII
  • 1000UI/750UI
  • 100UI/ml
  • 250UI
  • 250UI/190UI
  • 450UI/400UI
  • 500UI
  • 500UI FVW/500UI FVIII
  • 500UI+1200UI
  • 500UI/375UI
  • 900UI/800UI