Leaflet BERIATE 1000UI powder and solvent for solution for injection / infusion

Product code:
W61672001
Quantity:
1
Indicated for:
bleeding; coagulation disorders
Route of administration:
injectable / infusion
Substance:
coagulation factor VIII (coagulation factor)
ATC
B02BD02 — 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.

Coagulation factor VIII is an essential protein for the blood clotting process, playing a key role in forming the clot that stops bleeding. A deficiency of factor VIII causes hemophilia A, a hereditary disease characterized by spontaneous or prolonged bleeding. Treatment with factor VIII is vital for preventing and controlling these bleeding episodes.

Factor VIII is administered intravenously under medical supervision, with the dose determined by the severity of the deficiency and the type of bleeding. Treatment can be given prophylactically 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 factor VIII has significantly improved the quality of life for people with hemophilia A. Following medical advice and being informed about possible risks contribute to safe and effective treatment.

General data about BERIATE 1000UI

Substance:
coagulation factor VIII
Date of latest medicines list:
01-06-2026
Product code:
W61672001
Concentration:
1000UI
Pharmaceutical form:
powder and solvent for solution for injection / infusion
Quantity:
1
Product type:
Original
Price:
2503.26 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:
10925/2018/01
Shelf life:
3 years

Concentrations available for coagulation factor VIII

  • 1000UI
  • 100UI/ml
  • 2000UI
  • 200UI/ml
  • 250UI
  • 500UI
  • 50UI/ml

Compensation lists for BERIATE 1000UI CSL Behring

NHP 6.1 (C2) - Hemophilia and thalassemia

Price
2503.26 RON
Copayment
1907.63 RON
Patient
595.63 RON