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

Indicated for: bleeding; coagulation disorders

Route of administration: injectable / infusion

Substance: coagulation factor XIII (anticoagulant)

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

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

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 latest medicines list: 01-06-2026
  • Product code: W61352001
  • Concentration: 250UI
  • Pharmaceutical form: powder and solvent for solution for injection / infusion
  • Quantity: 1
  • Product type: Original
  • Price: 740.81 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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