Leaflet SOLIRIS 10mg / ml concentrate for solution for infusion


Indicated for: complement-mediated disorders

Route of administration: infusion

Substance: eculizumab (monoclonal antibody)

ATC: L04AJ01 (Antineoplastic and immunomodulating agents | Immunosuppressants | Complement inhibitors)

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.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Eculizumab is a monoclonal antibody used for the treatment of rare conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It works by inhibiting complement C5, preventing the destruction of blood cells and tissues.

The medication is administered intravenously, as directed by a doctor, and requires careful monitoring for adverse effects.

Side effects may include headache, hypertension, respiratory infections, or injection site reactions. In rare cases, severe infections such as meningitis may occur.

Eculizumab is not recommended for patients with hypersensitivity to this medication or without meningococcal vaccination.

General data about SOLIRIS 10mg / ml

  • Substance: eculizumab
  • Date of last drug list: 01-04-2026
  • Commercial code: W52098001
  • Concentration: 10mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 1
  • Product type: original
  • Prescription restrictions: S - Medicines prescription reserved for use in certain specialized fields.

Concentrations available for eculizumab

  • 10mg/ml
  • 300mg