Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
epoetin beta
Roche Registration GmbH
B03XA01
epoetin beta
Antianemic preparations
Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients;treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy;increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Revision: 33
Authorised
1997-07-16
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE USER NEORECORMON 500 IU NEORECORMON 2000 IU NEORECORMON 3000 IU NEORECORMON 4000 IU NEORECORMON 5000 IU NEORECORMON 6000 IU NEORECORMON 10,000 IU NEORECORMON 20,000 IU NEORECORMON 30,000 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE epoetin beta 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 or 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 NeoRecormon is and what it is used for 2. What you need to know before you use NeoRecormon 3. How to use NeoRecormon 4. Possible side effects 5. How to store NeoRecormon 6. Content of the pack and other information 1. WHAT NEORECORMON IS AND WHAT IT IS USED FOR NeoRecormon is a clear, colourless solution for injection under the skin _(subcutaneously)_ or into a vein _(intravenously). _ It contains a hormone called _epoetin beta_ , which stimulates the production of red blood cells. Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin. You must talk to your doctor if you do not feel better or if you feel worse. NeoRecormon is indicated for: • TREATING SYMPTOMATIC ANAEMIA CAUSED BY CHRONIC KIDNEY DISEASE (renal anaemia) in patients on dialysis, or not yet on dialysis. • PREVENTING ANAEMIA IN PREMATURE INFANTS (weighing 750 to 1500 g and born at less than 34 weeks). • TREATING ANAEMIA WITH RELATED SYMPTOMS IN ADULT CANCER PATIENTS RECEIVING CHEMOTHERAPY • TREATING PEOPLE DONATING THEIR OWN BLOOD BEFORE SURGERY. The injections of epoetin beta will increas Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2000 IU solution for injection in pre-filled syringe NeoRecormon 3000 IU solution for injection in pre-filled syringe NeoRecormon 4000 IU solution for injection in pre-filled syringe NeoRecormon 5000 IU solution for injection in pre-filled syringe NeoRecormon 6000 IU solution for injection in pre-filled syringe NeoRecormon 10,000 IU solution for injection in pre-filled syringe NeoRecormon 20,000 IU solution for injection in pre-filled syringe NeoRecormon 30,000 IU solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NeoRecormon 500 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 500 international units (IU) corresponding to 4.15 micrograms epoetin beta* (recombinant human erythropoietin). One ml solution for injection contains 1667 IU epoetin beta. NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin). One ml solution for injection contains 6667 IU epoetin beta. NeoRecormon 3000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin). One ml solution for injection contains 10,000 IU epoetin beta. NeoRecormon 4000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin). One ml solution for injection contains 13,333 IU epoetin beta. NeoRecormon 5000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution Przeczytaj cały dokument