European Union - English - EMA (European Medicines Agency)

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

European Union - English - EMA (European Medicines Agency)

hexal ag - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.mobilisation of peripheral blood progenitor cells (pbpcs).in children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.treatment of persistent neutropenia (anc ≤ 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

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

teva pharma australia pty ltd - lipegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections - lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Israel - English - Ministry of Health

amgen europe b.v. - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml ml - pegfilgrastim - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy. ( with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Israel - English - Ministry of Health

kamada ltd, israel - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

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

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

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

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

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

accord healthcare pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: water for injections; polysorbate 20; sorbitol; glacial acetic acid; sodium hydroxide - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

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

amgen inc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - pegfilgrastim 6 mg in 0.6 ml - neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . limitations of use neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see dosage and administration (2.2) and clinical studies (14.2)] . neulasta is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. reactions have included anaphylaxis [see warnings and precautions (5.3)] . risk summary although available data with neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outc