Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
ocrelizumab
Roche Registration GmbH
L04AA
ocrelizumab
Immunosuppressants
Multiple Sclerosis
Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
Revision: 18
Authorised
2018-01-08
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OCREVUS 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION ocrelizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ocrevus is and what it is used for 2. What you need to know before you are given Ocrevus 3. How Ocrevus is given 4. Possible side effects 5. How to store Ocrevus 6. Contents of the pack and other information 1. WHAT OCREVUS IS AND WHAT IT IS USED FOR WHAT OCREVUS IS Ocrevus contains the active substance ‘ocrelizumab’. It is a type of protein called a ‘monoclonal antibody’. Antibodies work by attaching to specific targets in your body. WHAT OCREVUS IS USED FOR Ocrevus is used to treat adults with: • Relapsing forms of multiple sclerosis (RMS) • Early primary progressive multiple sclerosis (PPMS) WHAT IS MULTIPLE SCLEROSIS Multiple Sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord. In MS, the immune system (the body’s defence system) works incorrectly and attacks a protective layer (called myelin sheath) around nerve cells and causes inflammation. Breakdown of the myelin sheath stops the nerves working properly. Symptoms of MS depend on which part of the central nervous system is affected and can include problems with walking and balance, weakness, numbness, double vision and blurring, poor coordination and bladder problems. • IN RELAPSING FORMS OF MS, the patient has repeated attacks of symptoms (relapses). The symptoms can appear suddenly within a few hours, or slowly over several days. The symptoms disappear or improve between relapses but damage may build up and lead to permanent disability. • IN PRIMARY PROGR Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL. The final drug concentration after dilution is approximately 1.2 mg/mL. Ocrelizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear to slightly opalescent, and colourless to pale brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1). Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs). Premedication for infusion-related reactions The following two premedications must be administered prior to each ocrelizumab infusion to reduce the frequency and severity of IRRs (see section 4.4 for additional steps to reduce IRRs): • 100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each infusion; • antihistamine approximately 30-60 minutes prior to each infusion; In addition, premedication with an antipyretic (e.g., paracetamol) may also be considered approximately 30-60 minutes prior to each infusion. Posology _Initial dose _ _ _ The initial 600 mg dose Lesen Sie das vollständige Dokument