País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Filgrastim, Quantity: 600 microgram/mL
Teva Pharma Australia Pty Ltd
Filgrastim
Injection, solution
Excipient Ingredients: glacial acetic acid; polysorbate 80; sodium hydroxide; sorbitol; water for injections
Intravenous, Subcutaneous
1, 5, 10
(S4) Prescription Only Medicine
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs in doses not usually requiring bone marrow transplantation. To reduce 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 or myelosuppressive therapy in patients with nonmyeloid 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, to reduce 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
Registered
2011-08-29
TEVAGRASTIM ® _filgrastim (rbe)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TEVAGRASTIM. Please note that this leaflet does not contain everything there is to know about TEVAGRASTIM. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has prescribed TEVAGRASTIM 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 YOUR MEDICINE. You may need to read this information again. WHAT TEVAGRASTIM IS USED FOR Your doctor may have prescribed TEVAGRASTIM because: 1. YOU ARE RECEIVING CHEMOTHERAPY FOR CANCER Unfortunately, some chemotherapy will reduce the number of neutrophils in your body. Although TEVAGRASTIM is not a treatment for cancer, it does help the body to make new neutrophils and 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. 2. 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 those lost during chemotherapy. This procedure is called a bone marrow or stem cell transplant. There are normally only a small number of stem cells in your blood; TEVAGRASTIM is typically used to increase this number before stem cell collection. You may also receive TEVAGRASTIM after a bone marrow or stem cell transplant, to help speed up your recovery. 3. YOU ARE DONATING STEM CELLS FOR ANOTHER PERSON If Llegiu el document complet
TEVAGRASTIM – Product Information V3.0 November 2018 Page 1 of 29 PRODUCT INFORMATION TEVAGRASTIM NAME OF THE MEDICINE Filgrastim (recombinant methionyl human granulocyte colony stimulating factor) Filgrastim is a 175 amino acid protein manufactured by recombinant DNA technology. It is produced by _Escherichia coli_ bacteria into which has been inserted the human granulocyte colony stimulating factor gene. Filgrastim is unglycosylated and contains an N-terminal methionine necessary for expression in _E. coli_ . Molecular weight: 18,800 CAS no. 121181-53-1 Chemical structure: DESCRIPTION TEVAGRASTIM Injections contain 600mcg/mL of filgrastim as the active ingredient. Excipients include glacial acetic acid, polysorbate 80, sodium hydroxide, sorbitol and water for injections. TEVAGRASTIM – Product Information V3.0 November 2018 Page 2 of 29 PHARMACOLOGY Actions: Colony stimulating factor. Colony stimulating factors are glycoproteins which act on haemopoietic cells by binding to specific cell surface receptors and stimulating proliferation, differentiation commitment, and some end-cell functional activation. Endogenous filgrastim (ie. granulocyte-colony stimulating factor) is a lineage specific colony stimulating factor with selectivity for the neutrophil lineage. Filgrastim is not species specific and has been shown to primarily affect neutrophil progenitor proliferation, differentiation and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst, antibody dependent killing and the increased expression of some functions associated with cell surface antigens). The pH of filgrastim is 4.12. Preclinical studies - The results of all preclinical studies indicate that the pharmacological effects of filgrastim are consistent with its predominant role as a regulator of neutrophil production and function. COMPARISON OF TEVAGRASTIM WITH NEUPOGEN Comparability assessment of primary pharmacodynamic _in vitro _ studies on receptor bi Llegiu el document complet