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

janssen-cilag pty ltd - epoetin alfa, quantity: 40000 iu/ml - injection, solution - excipient ingredients: glycine; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; 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.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; glycine; 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.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: glycine; dibasic sodium phosphate dihydrate; sodium chloride; water for injections; monobasic sodium phosphate; polysorbate 80 - 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.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; monobasic sodium phosphate; dibasic sodium phosphate dihydrate; glycine; polysorbate 80 - 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.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 4000 iu/ml - injection, solution - excipient ingredients: dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; glycine; monobasic sodium phosphate; 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 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.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 2000 iu/ml - injection, solution - excipient ingredients: glycine; sodium chloride; dibasic sodium phosphate dihydrate; water for injections; polysorbate 80; 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

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

sanofi-aventis australia pty ltd - diltiazem hydrochloride -

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - epoetin alfa 84 µg/ml (human recombinant erythropoietin (r-huepo cho)) - solution for injection - 10000 iu/ml - active: epoetin alfa 84 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 84 µg/ml (human recombinant erythropoietin (r-huepo cho));  ; epoetin alfa 84 µg/ml; epoetin alfa 84 µg/ml - solution for injection - 10000 iu/ml - active: epoetin alfa 84 µg/ml (human recombinant erythropoietin (r-huepo cho))   excipient: albumin dibasic sodium phosphate dihydrate glycine metacresol monobasic sodium phosphate dihydrate polysorbate 80 water for injection active: epoetin alfa 84 µg/ml excipient: albumin dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection active: epoetin alfa 84 µg/ml excipient: albumin monobasic sodium phosphate dihydrate sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - epoetin alfa 168 µg/ml (human recombinant erythropoietin (r-huepo cho));   - solution for injection - 20000 iu/ml - active: epoetin alfa 168 µg/ml (human recombinant erythropoietin (r-huepo cho))   excipient: albumin dibasic sodium phosphate dihydrate glycine metacresol monobasic sodium phosphate dihydrate polysorbate 80 water for injection