Leaflet PRONATIV 500UI powder+solvent for solution for infusion


Indicated for: bleeding; coagulation disorders

Route of administration: infusion

Substance: coagulation factors (anticoagulant)

ATC: B02BD01 (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 factors are essential proteins involved in the process of stopping bleeding, playing a key role in blood clot formation. Deficiency or dysfunction of these factors can lead to bleeding disorders such as hemophilia or von Willebrand disease. Treatment with coagulation factors is used to prevent or stop bleeding in people with such conditions.

Coagulation factors are administered intravenously under medical supervision, with the dose determined by the severity of the deficiency and the type of bleeding event. Treatment can be given preventively or as needed, for example during surgeries or after injuries.

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 coagulation factors 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 PRONATIV 500UI

  • Substance: coagulation factors
  • Date of last drug list: 01-06-2026
  • Commercial code: W65359002
  • Concentration: 500UI
  • Pharmaceutical form: powder+solvent for solution for infusion
  • Quantity: 1
  • Product type: original
  • Price: 1199.42 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: OCTAPHARMA PHARMAZEUTIKA PROD. GES.M.B.H. - AUSTRIA
  • Holder: OCTAPHARMA (IP) SPRL - BELGIA
  • Number: 7802/2015/01
  • Shelf life: 3 years

Pharmaceutical forms available for coagulation factors

Concentrations available for coagulation factors

  • 1000UI
  • 500UI
  • 600UI