Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
epoetin zeta
Stada Arzneimittel AG
B03XA01
epoetin zeta
Antianemic preparations
Anemia; Blood Transfusion, Autologous; Cancer; Kidney Failure, Chronic
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patientsTreatment of anaemia associated with chronic renal failure in adult and paediatric 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).Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving 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).Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml).Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ≤10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (
Revision: 17
Authorised
2007-12-18
66 B. PACKAGE LEAFLET 67 PACKAGE LEAFLET: INFORMATION FOR THE USER SILAPO 1 000 IU/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 2 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 3 000 IU/0.9 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 4 000 IU/0.4 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 5 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 6 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 8 000 IU/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 10 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 20 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 30 000 IU/0.75 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SILAPO 40 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE epoetin zeta 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 Silapo is and what it is used for 2. What you need to know before you use Silapo 3. How to use Silapo 4. Possible side effects 5. How to store Silapo 6. Contents of the pack and other information 1. WHAT SILAPO IS AND WHAT IT IS USED FOR Silapo contains the active substance epoetin zeta – a protein, that stimulates the bone marrow to produce more red blood cells, which carry haemoglobin (a substance that transports oxygen). Epoetin zeta is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way. SILAPO IS USED TO TREAT SYMPTOMATIC ANAEMIA CAUSED BY KIDNEY DISEASE in ch Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 mL solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per mL. _Excipient with known effect_ Each pre-filled syringe contains 0.15 mg phenylalanine. Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 mL solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per mL. _Excipient with known effect_ Each pre-filled syringe contains 0.30 mg phenylalanine. Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 mL solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per mL. _Excipient with known effect_ Each pre-filled syringe contains 0.45 mg phenylalanine. Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 mL solution for injec Przeczytaj cały dokument