Leaflet PROTHROMPLEX TOTAL 500UI powder and solvent for solution for injection

Product code:
W69668001
Quantity:
1
Indicated for:
bleeding; coagulation disorders
Route of administration:
injectable
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 PROTHROMPLEX TOTAL 500UI

Substance:
coagulation factors
Date of latest medicines list:
01-06-2026
Product code:
W69668001
Concentration:
500UI
Pharmaceutical form:
powder and solvent for solution for injection
Quantity:
1
Product type:
Original
Price:
1382.79 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
TAKEDA MANUFACTURING AUSTRIA AG - AUSTRIA
Holder:
BAXALTA INNOVATIONS GMBH - AUSTRIA
Number:
15041/2023/01
Shelf life:
3 years

Concentrations available for coagulation factors

  • 1000UI
  • 500UI
  • 600UI