Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Methoxy polyethylene glycol-epoetin beta
Roche Registration GmbH
B03XA03
methoxy polyethylene glycol-epoetin beta
Antianemic preparations
Anemia; Kidney Failure, Chronic
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).
Revision: 29
Authorised
2007-07-20
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE USER MIRCERA 30 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 120 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 200 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 250 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 360 MICROGRAMS/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE methoxy polyethylene glycol-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 of illness are the same as yours. • 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 MIRCERA is and what it is used for 2. What you need to know before you use MIRCERA 3. How to use MIRCERA 4. Possible side effects 5. How to store MIRCERA 6. Contents of the pack and other information 1. WHAT MIRCERA IS AND WHAT IT IS USED FOR This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated with typical symptoms, such as tiredness, weakness and shortness of breath. This means that you have too few red blood cells and your haemoglobin level is too low (your body’s tissues might not receive enough oxygen). MIRCERA is indicated to treat only the symptomatic an Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT MIRCERA 30 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 40 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 50 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 60 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 75 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 100 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 120 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 150 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 200 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 250 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE MIRCERA 360 MICROGRAMS/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MIRCERA 30 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 100 micrograms/ml MIRCERA 40 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ml. MIRCERA 50 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ml. MIRCERA 60 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 200 micrograms/ml. MIRCERA 75 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ml MIRCERA 100 MICROGRAMS/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE O Прочетете целия документ