Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
ropeginterferon alfa-2b
AOP Orphan Pharmaceuticals GmbH
L03AB15
ropeginterferon alfa-2b
Immunostimulants,
Polycythemia Vera
Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Revision: 4
Authorised
2019-02-15
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER BESREMI 250 MICROGRAMS/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN ropeginterferon alfa-2b 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Besremi is and what it is used for 2. What you need to know before you use Besremi 3. How to use Besremi 4. Possible side effects 5. How to store Besremi 6. Contents of the pack and other information 1. WHAT BESREMI IS AND WHAT IT IS USED FOR Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicines called interferons. Interferons are produced by your immune system to block the growth of cancer cells. Besremi is used as monotherapy for the treatment of polycythaemia vera in adults. Polycythaemia vera is a type of cancer in which the bone marrow produces too many red blood cells, white blood cells and platelets (cells that help the blood to clot). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BESREMI DO NOT USE BESREMI - if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine (listed in section 6). - if you have thyroid disease that is not controlled with medicines. - if you have or had severe mental disorders (such as depression or suicidal thoughts or if you tried to kill yourself). - if you have recently had severe heart problems (such as heart attack or stroke) - if you have or had an autoimmune disease (such as rheumatoid arthritis, psoriasis or inflammatory bowel disease). - if you had an organ transplantati Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL. Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1.000 micrograms/mL. The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation. Ropeginterferon alfa-2b is a covalent conjugate of the protein interferon alpha-2b, produced in _Escherichia coli_ cells by recombinant DNA technology, with a methoxypolyethylene glycol (mPEG) moiety. The potency of this medicinal product should not be compared to that of another pegylated or non- pegylated protein of the same therapeutic class (see section 5.1). Excipient with known effect Each pre-filled pen contains 10 mg benzyl alcohol per mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen (injection). Clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the management of the disease. Posology 3 _Titration phase_ The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy). The dose should be gradually increased by 50 microgra Olvassa el a teljes dokumentumot