Kraj: Malta
Język: angielski
Źródło: Medicines Authority
EPOETIN ALFA
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgium
B03XA01
EPOETIN ALFA 2000 IU/ml
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
EPOETIN ALFA 2000 IU/ml
POM
ANTIANEMIC PREPARATIONS
Withdrawn
2008-01-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EPREX 2,000 IU/ML, 4,000 IU/ML AND 10,000 IU/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES (epoetin alfa) 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, nurse 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, nurse, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What EPREX is and what it is used for 2. What you need to know before you use EPREX 3. How to use EPREX 4. Possible side effects 5. How to store EPREX 6. Contents of the pack and other information 1. WHAT EPREX IS AND WHAT IT IS USED FOR EPREX contains the active substance epoetin alfa - a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen). Epoetin alfa is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way. • EPREX IS USED TO TREAT SYMPTOMATIC ANAEMIA CAUSED BY KIDNEY DISEASE • in children on haemodialysis • in adults on haemodialysis or peritoneal dialysis • in severely anaemic adults not yet undergoing dialysis. If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production). EPREX is prescribed to stimulate your bone marrow to produce more red blood cells. • EPREX IS USED TO TREAT ANAEMIA IN ADULTS RECEIVING CHEMOTHERAPY FOR SOLID TUMOURS, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion. EPREX can reduce the need for a blood transfusion in these patients. • EPREX IS USED IN MODERATELY ANAEMIC ADULTS WHO DONATE Przeczytaj cały dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT EPREX 2,000 IU/mL solution for injection in pre-filled syringe. EPREX 4,000 IU/mL solution for injection in pre-filled syringe. EPREX 10,000 IU/mL solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EPREX 2,000 IU/mL solution for injection in pre-filled syringe Epoetin alfa 2,000 IU/mL (16.8 micrograms per mL), produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology A pre-filled syringe of 0.5 mL contains 1,000 IU (8.4 micrograms) of epoetin alfa. EPREX 4,000 IU/mL solution for injection in pre-filled syringe Epoetin alfa 4,000 IU/mL (33.6 micrograms per mL), produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology A pre-filled syringe of 0.5 mL contains 2,000 IU (16.8 micrograms) of epoetin alfa. EPREX 10,000 IU/mL solution for injection in pre-filled syringe Epoetin alfa 10,000 IU/mL (84.0 micrograms per mL), produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology A pre-filled syringe of 0.3 mL contains 3,000 IU (25.2 micrograms) of epoetin alfa A pre-filled syringe of 0.4 mL contains 4,000 IU (33.6 micrograms) of epoetin alfa A pre-filled syringe of 0.5 mL contains 5,000 IU (42.0 micrograms) of epoetin alfa A pre-filled syringe of 0.6 mL contains 6,000 IU (50.4 micrograms) of epoetin alfa A pre-filled syringe of 0.8 mL contains 8,000 IU (67.2 micrograms) of epoetin alfa A pre-filled syringe of 1.0 mL contains 10,000 IU (84.0 micrograms) of epoetin alfa For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EPREX is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): • in adults and paediatrics aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis. • in adults with renal insufficiency not yet undergoing dialysis for the treatment of se Przeczytaj cały dokument