BETAFACT 50UI / ml powder + solvent for injection medication leaflet

B02BD04 coagulation factor IX • Blood and blood forming organs | Vitamin k and other hemostatics | Blood coagulation factors

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

Factor IX 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 IX has significantly improved the quality of life for people with hemophilia B. Following medical advice and being informed about possible risks contribute to safe and effective treatment.

General data about BETAFACT 50UI / ml

Substance: coagulation factor IX

Date of last drug list: 01-07-2015

Commercial code: W58659002

Concentration: 50UI / ml

Pharmaceutical form: powder + solvent for injection

Quantity: 1

Product type: original

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: LFB - BIOMEDICAMENTS - FRANTA

Holder: LFB - BIOMEDICAMENTS - FRANTA

Number: 10093/2017/02

Shelf life: 30 months-after packing for marketing; after reconstitution - it is used immediately

Concentrations available for coagulation factor IX

1000UI, 100UI/ml, 1200UI, 200UI, 250UI, 500UI, 50UI/ml, 600UI