Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
natalizumab
Biogen Netherlands B.V.
L04AA23
natalizumab
Selective immunosuppressants
Multiple Sclerosis
Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1), , 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.
Revision: 41
Authorised
2006-06-27
57 B. PACKAGE LEAFLET 58 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TYSABRI 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION natalizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. In addition to this leaflet you will be given a patient alert card. This contains important safety information that you need to know before and during treatment with Tysabri. • Keep this leaflet and the patient alert card. You may need to read them again. Keep the leaflet and patient alert card with you during treatment and for six months after the last dose of this medicine , as side effects may occur even after you have stopped treatment. • 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 TYSABRI IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TYSABRI 3. HOW TYSABRI IS GIVEN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TYSABRI 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TYSABRI IS AND WHAT IT IS USED FOR Tysabri is used to treat multiple sclerosis (MS). It contains the active substance natalizumab. This is called a monoclonal antibody. MS causes inflammation in the brain that damages the nerve cells. This inflammation happens when white blood cells get into the brain and spinal cord. This medicine stops the white blood cells getting through to the brain. This reduces nerve damage caused by MS. SYMPTOMS OF MULTIPLE SCLEROSIS The symptoms of MS vary from patient to patient, and you may experience some or none of them. THEY MAY INCLUDE: walking problems, numbness in the face, arms or legs; problems with vision; tiredness; feeling off-balance or light headed; bladder and bowel problems; difficulty in thinking and concentrating; depression; acute or chronic pain; sexual problems; stiffness and muscle spasms. When the symptoms flare up, it is called a _relapse_ Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tysabri 300 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg of natalizumab. When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg per mL of natalizumab. Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology. Excipient with known effect Each vial contains 2.3 mmol (or 52 mg) sodium (see section 4.4 for further information). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Colourless, clear to slightly opalescent solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tysabri is indicated as 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) (for exceptions and information about washout periods see sections 4.4 and 5.1) or • Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI. Patients treated with this medicinal product must be given the patient alert card and be informed about the risks of the medicinal product (see also package leaflet). After 2 years of treatment, patients should be re-informed about the risks, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed toge Прочетете целия документ