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

pfizer australia pty ltd - filgrastim, quantity: 480 microgram - injection, solution - excipient ingredients: polysorbate 80; sodium; water for injections; acetate; sorbitol - a) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation, b) for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia, c) for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies, d) for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation, e) in patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation, f) for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia, g) in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

pfizer australia pty ltd - filgrastim, quantity: 120 microgram - injection, solution - excipient ingredients: sorbitol; polysorbate 80; acetate; water for injections; sodium - a) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation, b) for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia, c) for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies, d) for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation, e) in patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation, f) for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia, g) in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

sandoz pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: sodium hydroxide; polysorbate 80; water for injections; glutamic acid; sorbitol - indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. ,indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies. ,indicated for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.,in patients receiving myeloablative chemotherapy, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia.,indicated in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

sandoz pty ltd - filgrastim, quantity: 960 microgram/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; sodium hydroxide; glutamic acid; water for injections - indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. ,indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies. ,indicated for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.,in patients receiving myeloablative chemotherapy, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia.,indicated in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

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

sandoz pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: polysorbate 20; acetic acid; sodium hydroxide; water for injections; sorbitol - 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.

European Union - English - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - colony stimulating factors - biograstim 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.biograstim 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 biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.biograstim 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.

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)

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

Kenya - English - Pharmacy and Poisons Board

pegfilgrastim - injection - 6mg of pegylated filgrastim drug substance - pegfilgrastim