New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - epoetin alfa 336 µg/ml (human recombinant erythropoietin) - solution for injection - 40000 iu/ml - active: epoetin alfa 336 µg/ml (human recombinant erythropoietin) excipient: dibasic sodium phosphate dihydrate glycine monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride water for injection - eprex is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis. · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis. · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy. · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - epoetin alfa 33.6 µg/ml (human recombinant erythropoietin(r-huepo cho)) - solution for injection - 4000 iu/ml - active: epoetin alfa 33.6 µg/ml (human recombinant erythropoietin(r-huepo cho)) excipient: dibasic sodium phosphate dihydrate glycine monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride water for injection - eprex is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis. · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis. · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy. · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 1000 iu / 0.5 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 2000 iu / 1 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 30000 iu / 0.75 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 4000 iu / 0.4 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 5000 iu / 0.5 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 6000 iu / 0.6 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 10000 iu / 1 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 20000 iu / 0.5 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children 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 severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), 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).binocrit® 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. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).