Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
alemtuzumab
Sanofi Belgium
L04AA34
alemtuzumab
Selective immunosuppressants
Multiple Sclerosis
Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Revision: 22
Authorised
2013-09-12
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEMTRADA 12 MG CONCENTRATE FOR SOLUTION FOR INFUSION alemtuzumab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE ADMINISTERED 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. - If you get any side-effects talk to your doctor. This includes any possible side-effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What LEMTRADA is and what it is used for 2. What you need to know before you are administered LEMTRADA 3. How LEMTRADA will be administered 4. Possible side effects 5. How to store LEMTRADA 6. Contents of the pack and other information 1. WHAT LEMTRADA IS AND WHAT IT IS USED FOR LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting multiple sclerosis (RRMS). LEMTRADA does not cure MS, but it can reduce the number of MS relapses. It can also help to slow down or reverse some of the signs and symptoms of MS. In clinical studies, patients treated with LEMTRADA had fewer relapses and were less likely to experience worsening of their disability compared to patients treated with a beta-interferon injected multiple times per week. LEMTRADA is used if your MS is highly active despite that you have been treated with at least one other medicine for MS or if your MS is rapidly evolving. WHAT IS MULTIPLE SCLEROSIS? MS is an autoimmune disease that affects the central nervous system (brain and spinal cord). In MS your immune system mistakenly attacks the protective layer (myelin) around the nerve fibres, causing inflammation. When the inflammation causes symptoms this is often called an “a Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT LEMTRADA 12 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml). Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology. Excipients with known effect This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassium- free’. This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). A clear, colourless to slightly yellow concentrate with pH 7.0 – 7.4. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis (MS) in a hospital with ready access to intensive care. Specialists and equipment required for the timely diagn Soma hati kamili