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 16.8 µg/ml (human recombinant erythropoietin (r-huepo cho));  ; epoetin alfa 16.8 µg/ml - solution for injection - 2000 iu/ml - active: epoetin alfa 16.8 µg/ml (human recombinant erythropoietin (r-huepo cho))   excipient: albumin dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride water for injection active: epoetin alfa 16.8 µg/ml excipient: albumin dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - epoetin alfa 33.6 µg/ml (human recombinant erythropoietin (r-huepo cho));  ; epoetin alfa 33.6 µg/ml (human recombinant erythropoietin (r-huepo cho)); epoetin alfa 33.6 µg/ml - solution for injection - 4000 iu/ml - active: epoetin alfa 33.6 µg/ml (human recombinant erythropoietin (r-huepo cho))   excipient: albumin dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride water for injection active: epoetin alfa 33.6 µg/ml (human recombinant erythropoietin (r-huepo cho)) excipient: albumin dibasic sodium phosphate dihydrate glycine metacresol monobasic sodium phosphate dihydrate water for injection active: epoetin alfa 33.6 µg/ml excipient: albumin dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water

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

sanofi-aventis australia pty ltd - teriflunomide, quantity: 14 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate; microcrystalline cellulose; hyprolose; maize starch; lactose monohydrate; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake - aubagio is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

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

sanofi-aventis australia pty ltd - glimepiride, quantity: 4 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate; povidone; microcrystalline cellulose; indigo carmine - dimirel is indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.

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

sanofi-aventis australia pty ltd - glimepiride, quantity: 3 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; iron oxide yellow; sodium starch glycollate; povidone; lactose monohydrate; magnesium stearate - dimirel is indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.

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

sanofi-aventis australia pty ltd - glimepiride, quantity: 2 mg - tablet, uncoated - excipient ingredients: iron oxide yellow; magnesium stearate; microcrystalline cellulose; povidone; lactose monohydrate; indigo carmine; sodium starch glycollate - dimirel is indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.