Leaflet BENEFIX 3000UI powder and solvent for solution for injection
Indicated for: bleeding; coagulation disorders
Route of administration: injectable
Substance: nonacog alfa (anticoagulant)
ATC: B02BD04 (Blood and blood forming organs | Vitamin k and other hemostatics | Blood coagulation factors)
Dose adjustment may be needed in kidney disease.
This medicine may have important interactions with other medicines.
This medicine is subject to additional monitoring.
Use during breastfeeding only on medical advice.
Use during pregnancy only on medical advice.
This medicine may increase the risk of bleeding.
Recombinant coagulation factor IX is a medicine used in people with haemophilia B, an inherited bleeding disorder in which factor IX is missing or too low and blood does not clot normally. It is used to stop bleeding episodes, prevent bleeds with regular treatment, and provide cover before surgery, dental work or other situations with a higher bleeding risk.
The medicine replaces the missing clotting factor IX and helps the body form a stable clot after injury. It does not cure haemophilia and it is not used for haemophilia A, which is caused by lack of factor VIII. For patients, the aim is fewer bleeds into joints, muscles or other tissues, less pain, and better protection of joints and movement over time.
It is given by intravenous injection after the powder has been mixed with the solvent. Treatment should be supervised by a doctor experienced in haemophilia care; some patients or carers may be trained to give it at home. The dose and schedule depend on body weight, severity of deficiency, type of bleed, planned procedures and individual response. Blood tests may be needed to check factor IX levels.
Possible side effects include injection-site pain, fever, headache, dizziness, nausea or allergic reactions. Get urgent medical help for hives, wheezing, swelling of the face or throat, chest tightness, fainting, or bleeding that does not improve. Rarely, inhibitors against factor IX or blood clots may occur, so regular follow-up with the haemophilia team is important.
General data about BENEFIX 3000UI
- Substance: nonacog alfa
- Date of latest medicines list: 01-01-2014
- Product code: W60171001
- Concentration: 3000UI
- Pharmaceutical form: powder and solvent for solution for injection
- Quantity: 1
- Product type: Original
- Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.
Concentrations available for nonacog alfa
- 1000UI
- 2000UI
- 250UI
- 3000UI
- 500UI