Manufacturer
Alexion Pharma International Operations Limited(IRELAND)

Registraction Number
MAL24096027ACZ

Content:
Soliris 10mg/ml Concentrate for Solution for Infusion contains 10 mg of eculizumab in 1 ml. Eculizumab is a humanized monoclonal antibody that inhibits the complement system and is used to treat several rare and serious disorders.
Indications:

• Paroxysmal Nocturnal Haemoglobinuria (PNH): Treatment of adults and children with PNH to reduce hemolysis.
• Atypical Haemolytic Uremic Syndrome (aHUS): Treatment of adults and children with aHUS to inhibit complement-mediated thrombotic microangiopathy.
• Refractory Generalized Myasthenia Gravis (gMG): Treatment of adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.
• Neuromyelitis Optica Spectrum Disorder (NMOSD): Treatment of adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.

Instructions:

1. Administration: Administered as an intravenous infusion under the supervision of a healthcare professional.
2. Dosage: The dosing regimen varies depending on the condition being treated. For example, for PNH, the initial phase consists of 600 mg administered weekly for the first 4 weeks, followed by a maintenance phase of 900 mg every 14 days1.
3. Timing: Take it at the same time each day to help you remember.
4. Monitoring: Regular monitoring of blood counts and other parameters is essential.