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

roche products pty ltd - epoetin beta, quantity: 6666.66 iu/ml - injection - excipient ingredients: calcium chloride dihydrate; dibasic sodium phosphate dodecahydrate; water for injections; glutamic acid; isoleucine; urea; monobasic sodium phosphate; polysorbate 20; glycine; phenylalanine; leucine; sodium chloride; threonine - neorecormon is indicated for the treatment of anaemia associated with chronic kidney disease (ckd) in patients on dialysis and symptomatic patients not yet undergoing dialysis. to increase the yield of autologous blood from patients in pre-donation programme initiated to avoid the use of homologous blood. for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks. for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.

United States - English - NLM (National Library of Medicine)

vifor (international) inc. - methoxy polyethylene glycol-epoetin beta (unii: lr3uxn0193) (methoxy polyethylene glycol-epoetin beta - unii:lr3uxn0193) - methoxy polyethylene glycol-epoetin beta 30 ug in 0.3 ml - mircera is indicated for the treatment of anemia associated with chronic kidney disease (ckd) in: limitations of use mircera is not indicated and is not recommended: mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life. mircera is contraindicated in patients with: risk summary available data from a small number of published case reports and postmarketing experience with mircera use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. chronic kidney disease is associated with maternal and embryo-fetal risks (see clinical considerations) . in animal reproduction studies, administration of methoxy polyethylene glycol-epoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populatio

United States - English - NLM (National Library of Medicine)

amgen inc - darbepoetin alfa (unii: 15uq94pt4p) (darbepoetin alfa - unii:15uq94pt4p) - darbepoetin alfa 10 ug in 0.4 ml - aranesp is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and patients not on dialysis. aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. aranesp has not been shown to improve quality of life, fatigue, or patient well-being. aranesp is not indicated for use: •       in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. •       in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. •       in patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. •       as a substitute for rbc transfusions in patients who require immediate correction o

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

sandoz pty ltd - epoetin lambda, quantity: 9000 iu - injection, solution - excipient ingredients: sodium hydroxide; glycine; monobasic sodium phosphate dihydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; sodium chloride; dilute hydrochloric acid - 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.. treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. adult patients with mild to moderate anaemia (haemoglobin > 100 to less than or equal to 130g/l) scheduled for elective surgery with an expected moderate blood loss (two to four units or 900 to 1,800ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.. 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 predeposit their complete perioperative blood needs.

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

sandoz pty ltd - epoetin lambda, quantity: 7000 iu - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; dibasic sodium phosphate dihydrate; glycine; dilute hydrochloric acid; monobasic sodium phosphate dihydrate; water for injections; polysorbate 80 - 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.. treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. adult patients with mild to moderate anaemia (haemoglobin > 100 to less than or equal to 130g/l) scheduled for elective surgery with an expected moderate blood loss (two to four units or 900 to 1,800ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.. 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 predeposit their complete perioperative blood needs.

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.05 mg - injection, solution - excipient ingredients: sodium sulfate; monobasic sodium phosphate monohydrate; poloxamer; methionine; mannitol; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.03 mg - injection, solution - excipient ingredients: mannitol; sodium sulfate; poloxamer; methionine; monobasic sodium phosphate monohydrate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.12 mg - injection, solution - excipient ingredients: sodium sulfate; monobasic sodium phosphate monohydrate; poloxamer; methionine; mannitol; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.1 mg - injection, solution - excipient ingredients: sodium sulfate; poloxamer; monobasic sodium phosphate monohydrate; mannitol; methionine; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.2 mg - injection, solution - excipient ingredients: poloxamer; sodium sulfate; methionine; mannitol; monobasic sodium phosphate monohydrate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).