Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
Filgrastim, Quantity: 600 microgram/mL
Amgen Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium; acetate; sorbitol; polysorbate 80
Intravenous, Subcutaneous
1 x 5 syringe, 1 x 1 syringe, 1 x 10 syringe
(S4) Prescription Only Medicine
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. For reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. 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 of myelosuppressive therapy in patients with non-myeloid malignancies. 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, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. For chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. 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
Visual Identification: Clear, colourless solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1995-11-13
NEUPOGEN ® _Filgrastim (rbe)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NEUPOGEN. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has prescribed NEUPOGEN after considering its likely benefit to you, as well as the potential risks. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NEUPOGEN IS USED FOR NEUPOGEN is a copy of a substance normally present in your body, called Granulocyte Colony Stimulating Factor or G-CSF. Using gene technology, NEUPOGEN is produced in a specific type of bacteria, called E. coli. G-CSF is produced in the bone marrow and assists in the production of neutrophils, which are a type of white blood cell. Neutrophils help the body fight infections by surrounding and destroying the bacteria that cause them. G-CSF also helps neutrophils to do this work better. Your doctor may have prescribed NEUPOGEN because: • YOU ARE RECEIVING CHEMOTHERAPY FOR CANCER. Unfortunately, some chemotherapy will reduce the number of neutrophils in your body. Although NEUPOGEN is not a treatment for cancer, it does help the body to make new neutrophils. This will reduce your chance of developing infections that might require antibiotics and/ or hospital stays. It may even increase your chance of receiving your chemotherapy on time and at the right dose. • YOU ARE RECEIVING A BONE MARROW OR STEM CELL TRANSPLANT. Blood cells are produced in the bone marrow and arise from special 'parent' cells, called stem cells. Some chemotherapy has toxic effects on bone marrow, so your doctor may choose to collect stem cells from your bone marrow or blood - or from a donor's bone marrow or blood - before you receive your chemotherapy. These collected stem cells are then stored and may be given back to you later, to replace t Izlasiet visu dokumentu
NEUPOGEN ® (FILGRASTIM) – SOLUTION FOR INJECTION – PRODUCT INFORMATION PAGE 1 OF 34 AUSTRALIAN PI - NEUPOGEN (FILGRASTIM) 1 NAME OF THE MEDICINE NEUPOGEN is the Amgen Inc. trademark for filgrastim (rbe), a recombinant methionyl human granulocyte colony stimulating factor. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NEUPOGEN is available in single use prefilled syringes and vials. The single use prefilled syringes contain either 300 g or 480 g filgrastim at a fill volume of 0.5 mL. The single use vials contain either 300 g or 480 g filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. For the full list of excipients, see Section 6.1 List of excipients_. _ 3 PHARMACEUTICAL FORM NEUPOGEN is a sterile, clear, colourless, preservative-free liquid for parenteral administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEUPOGEN is 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. NEUPOGEN is indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia (AML). NEUPOGEN is 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. NEUPOGEN is indicated for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell (PBPC) transplantation. NEUPOGEN ® (FILGRASTIM) – SOLUTION FOR INJECTION – PRODUCT INFORMATION PAGE 2 OF 34 In patients receiving myeloablative chemotherapy, NEUPOGEN is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or Izlasiet visu dokumentu