Leaflet IMMUNINE 1200UI powder and solvent for solution for injection / infusion

Indicated for: bleeding; coagulation disorders

Route of administration: injectable / infusion

Substance: coagulation factor IX (coagulation factor)

ATC: B02BD04 (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 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 IMMUNINE 1200UI

  • Substance: coagulation factor IX
  • Date of latest medicines list: 01-06-2026
  • Product code: W62890001
  • Concentration: 1200UI
  • Pharmaceutical form: powder and solvent for solution for injection / infusion
  • Quantity: 1
  • Product type: Original
  • Price: 2192.60 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: BAXTER AG - AUSTRIA
  • Holder: BAXALTA INNOVATIONS GMBH - AUSTRIA
  • Number: 4466/2012/01
  • Shelf life: 2 years-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

Compensation lists for IMMUNINE 1200UI Baxalta

NHP 6.1 (C2) - Hemophilia and thalassemia

Price

Copayment

Patient

2192.60 RON

2192.60 RON

0.00 RON