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

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

roche products pty ltd - epoetin beta, quantity: 16666.67 iu/ml - injection - excipient ingredients: threonine; polysorbate 20; urea; water for injections; dibasic sodium phosphate dodecahydrate; glutamic acid; leucine; sodium chloride; calcium chloride dihydrate; monobasic sodium phosphate; phenylalanine; glycine; isoleucine - 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.

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

roche products pty ltd - epoetin beta, quantity: 20000 iu/ml - injection - excipient ingredients: polysorbate 20; monobasic sodium phosphate; sodium chloride; urea; isoleucine; glycine; threonine; calcium chloride dihydrate; glutamic acid; dibasic sodium phosphate dodecahydrate; phenylalanine; leucine; water for injections - 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.

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

roche products pty ltd - epoetin beta, quantity: 16666.67 iu/ml - injection - excipient ingredients: glutamic acid; leucine; isoleucine; polysorbate 20; water for injections; dibasic sodium phosphate dodecahydrate; urea; monobasic sodium phosphate; phenylalanine; threonine; calcium chloride dihydrate; glycine; sodium chloride - 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.

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

roche products pty ltd - epoetin beta, quantity: 13333.33 iu/ml - injection - excipient ingredients: leucine; phenylalanine; polysorbate 20; glycine; urea; water for injections; sodium chloride; calcium chloride dihydrate; monobasic sodium phosphate; threonine; glutamic acid; isoleucine; dibasic sodium phosphate dodecahydrate - 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.

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

roche products pty ltd - epoetin beta, quantity: 10000 iu/ml - injection - excipient ingredients: monobasic sodium phosphate; glycine; polysorbate 20; leucine; threonine; water for injections; isoleucine; calcium chloride dihydrate; phenylalanine; urea; glutamic acid; dibasic sodium phosphate dodecahydrate; sodium chloride - 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.

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.

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).