Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - epoetin alfa, quantity: 40000 iu/ml - injection, solution - excipient ingredients: glycine; polysorbate 80; monobasic sodium phosphate; water for injections; dibasic sodium phosphate dihydrate; sodium chloride - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the prevention and treatment of anaemia in adult patients with non-myeloid malignancies, where anaemia is anticipated to develop and develops as a result of concomitantly administered chemotherapy. eprex is indicated to decrease the need for transfusion in patients who will continue to receive concomitant chemotherapy for a minimum of two months. eprex is also indicated in adult patients with mild-to-moderate anaemia (haemoglobin >10 <=13 g/dl) scheduled for elective surgery with an expected moderate blood loss (2-4 units to 900 to 1800ml) to reduce exposure to allogenic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adults patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - epoetin alfa, quantity: 40000 iu/ml - injection, solution - excipient ingredients: polysorbate 80; dibasic sodium phosphate dihydrate; glycine; water for injections; sodium chloride; monobasic sodium phosphate - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.

European Union - English - EMA (European Medicines Agency)

hexal ag - epoetin alfa - anemia; kidney failure, chronic; cancer - antianemic preparations - 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).,

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - epoetin alfa 336 µg/ml - solution for injection - 336 mcg/ml - active: epoetin alfa 336 µg/ml excipient: dibasic sodium phosphate dihydrate glycine hydrochloric acid monobasic sodium phosphate dihydrate nitrogen polysorbate 80 sodium chloride sodium hydroxide water for injection - binocrit 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 < 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) 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)

sandoz new zealand limited - epoetin alfa 16.8 µg/ml - solution for injection - 16.8 mcg/ml - active: epoetin alfa 16.8 µg/ml excipient: dibasic sodium phosphate dihydrate glycine hydrochloric acid monobasic sodium phosphate dihydrate nitrogen polysorbate 80 sodium chloride sodium hydroxide water for injection - binocrit 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 < 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) 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 16.8 µg/ml (human recombinant erythropoietin(r-huepo cho)) - solution for injection - 2000 iu/ml - active: epoetin alfa 16.8 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.

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 336 µg/ml - solution for injection - 40000 iu/ml - active: epoetin alfa 336 µg/ml 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - darbepoetin alfa, quantity: 200 microgram/ml - injection, solution - excipient ingredients: monobasic sodium phosphate monohydrate; polysorbate 80; sodium chloride; dibasic sodium phosphate; water for injections - aranesp is indicated for the treatment of anaemia associated with chronic renal failure (crf). aranesp is also indicated for the treatment of anaemia and reduction of transfusion requirements in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy