Leaflet CLUVOT 250UI powder+solvent for injection / infusion solution


Indicated for: bleeding; coagulation disorders

Substance: coagulation factor XIII (anticoagulant)

ATC: B02BD07 (Blood and blood forming organs | Vitamin k and other hemostatics | Blood coagulation factors)

Coagulation factor XIII is an important protein in the blood clotting process, playing a role in stabilizing the formed clot and preventing its premature dissolution. Factor XIII deficiency is a rare condition that can lead to prolonged bleeding, slow wound healing, and, in some cases, serious complications.

Treatment with factor XIII is administered intravenously under medical supervision, with the dose determined by the severity of the deficiency and the patient's needs. Administration can be prophylactic 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 XIII has significantly improved the quality of life for people with this deficiency. Following medical advice and being informed about possible risks contribute to safe and effective treatment.

General data about CLUVOT 250UI

  • Substance: coagulation factor XIII
  • Date of last drug list: 01-05-2026
  • Commercial code: W61352001
  • Concentration: 250UI
  • Pharmaceutical form: powder+solvent for injection / infusion solution
  • Quantity: 1
  • Product type: original
  • Price: 740.81 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: CSL BEHRING GMBH - GERMANIA
  • Holder: CSL BEHRING GMBH - GERMANIA
  • Number: 11519/2019/01
  • Shelf life: 3 years

Concentrations available for coagulation factor XIII

  • 1250UI
  • 250UI