Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - methoxy polyethylene glycol-epoetin beta - solution for injection - methoxy polyethylene glycol-epoetin beta 150 mcg / 0.3 ml - methoxy polyethylene glycol-epoetin beta - methoxy polyethylene glycol-epoetin beta - treatment of anemia associated with chronic kidney disease (ckd).

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - methoxy polyethylene glycol-epoetin beta - solution for injection - methoxy polyethylene glycol-epoetin beta 200 mcg / 0.3 ml - methoxy polyethylene glycol-epoetin beta - methoxy polyethylene glycol-epoetin beta - treatment of anemia associated with chronic kidney disease (ckd).

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 5000 iu / 0.3 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency* and are receiving anti-tumor therapy. * deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 10000 iu / 0.6 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with chemotherapy. treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency* and are receiving anti-tumor therapy. * deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 4000 iu / 0.3 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 6000 iu / 0.3 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis.increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 30000 iu / 0.6 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with chemotherapy . treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy. deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - epoetin beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients;treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy;increasing the yield of autologous blood from patients in a pre-donation programme. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anaemia (hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 10000 [iu] (in 0.6ml) - solution for injection - 10000 iu/0.6ml - active: epoetin beta 10000 [iu] (in 0.6ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - 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. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 1000 [iu] - solution for injection - 1000 iu/0.3ml - active: epoetin beta 1000 [iu] excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection