Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Eculizumab
Alexion Europe SAS
L04AA25
eculizumab
Immunosuppressants
Hemoglobinuria, Paroxysmal
Soliris is indicated in adults and children for the treatment of:Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). Atypical haemolytic uremic syndrome (aHUS).Soliris is indicated in adults for the treatment of:Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
Revision: 36
Authorised
2007-06-20
49 B. PACKAGE LEAFLET _ _ _ _ 50 PACKAGE LEAFLET: INFORMATION FOR THE USER SOLIRIS 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION Eculizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Soliris is and what it is used for 2. What you need to know before you use Soliris 3. How to use Soliris 4. Possible side effects 5. How to store Soliris 6. Contents of the pack and other information 1. WHAT SOLIRIS IS AND WHAT IT IS USED FOR WHAT IS SOLIRIS Soliris contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies. Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body’s systems from attacking and destroying vulnerable blood cells, kidneys, muscles or eye nerves and spinal cord. WHAT IS SOLIRIS USED FOR PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells. ATYPICAL HAEMOLYTIC UREMIC SYNDROME Soliris is also used to treat adults and children patients with a certain type of disease affecting the blood system an Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Eculizumab is a humanised monoclonal (IgG 2/4κ ) antibody produced in NS0 cell line by recombinant DNA technology. One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml). After dilution, the final concentration of the solution to be infused is 5 mg/ml. Excipients with known effect: Sodium (5 mmol per vial) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colorless, pH 7.0 solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Soliris is indicated in adults and children for the treatment of: - Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). - Atypical haemolytic uremic syndrome (aHUS) (see section 5.1). - Refractory generalized myasthenia gravis (gMG) in patients aged 6 years and above who are anti- acetylcholine receptor (AChR) antibody-positive (see section 5.1). Soliris is indicated in adults for the treatment of: - Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuro- inflammatory disorders. Home infusion may be considered for patients who have tolerated infusions well in the clinic. The decision of a patient to receive home infusions should be made after evaluation and recommendation from the treating physician. Home infusions should be performed by a qualified healthcare professional. Posology 3 _Paroxysmal Nocturnal Haemoglobinuria Aqra d-dokument sħiħ