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 - 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).

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.36 mg - injection, solution - excipient ingredients: monobasic sodium phosphate monohydrate; sodium sulfate; poloxamer; 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: 0.075 mg - injection, solution - excipient ingredients: mannitol; methionine; monobasic sodium phosphate monohydrate; poloxamer; sodium sulfate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

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

genentech, inc. - methoxy polyethylene glycol-epoetin beta (unii: lr3uxn0193) (methoxy polyethylene glycol-epoetin beta - unii:lr3uxn0193) - methoxy polyethylene glycol-epoetin beta 50 ug in 0.3 ml - mircera is indicated for the treatment of anemia associated with chronic kidney disease (ckd) in adult patients on dialysis and patients not on dialysis. mircera is not indicated and is not recommended: - in the treatment of anemia due to cancer chemotherapy [see warnings and precautions (5.2)] - as a substitute for rbc transfusions in patients who require immediate correction of anemia [see clinical pharmacology (12.2)] mircera has not been shown to improve symptoms, physical functioning or health-related quality of life. mircera is contraindicated in patients with: - uncontrolled hypertension [see warnings and precautions (5.3)] - pure red cell aplasia (prca) that begins after treatment with mircera or other erythropoietin protein drugs [see warnings and precautions (5.6)] - history of serious or severe allergic reactions to mircera (e.g. anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria). risk summary there are no adequate and well-controlled studies in pregnant women. mircera

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

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.25 mg - injection, solution - excipient ingredients: monobasic sodium phosphate monohydrate; sodium sulfate; methionine; mannitol; poloxamer; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).