Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
epoetin alfa
Sandoz GmbH
B03XA01
epoetin alfa
Antianemic preparations
Anemia; Kidney Failure, Chronic
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Revision: 22
Authorised
2007-08-28
75 B. PACKAGE LEAFLET 76 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BINOCRIT 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 2,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 3,000 IU/0.3 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 4,000 IU/0.4 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 6,000 IU/0.6 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 7,000 IU/0.7 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 8,000 IU/0.8 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 9,000 IU/0.9 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 10,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 20,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 30,000 IU/0.75 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 40,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Binocrit is and what it is used for 2. What you need to know before you use Binocrit 3. How to use Binocrit 4. Possible side effects 5. How to store Binocrit 6. Contents of the pack and other information 1. WHAT BINOCRIT IS AND WHAT IT IS USED FOR Binocrit 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). Epoe Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Binocrit 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Binocrit 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Binocrit 10,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Each mL of solution contains 2,000 IU of epoetin alfa * corresponding to 16.8 micrograms per mL A pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa. * Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 2,000 IU of epoetin alfa * corresponding to 16.8 micrograms per mL A pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa. * Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa * corresponding to 84.0 micrograms per mL A pre-filled syringe of 0.3 mL contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa. * Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa * Aqra d-dokument sħiħ