The need to supplement the instructions for the use of medicines containing filgrastim, the following information:
1. In the section "Indications for use", indicate "Adults and children." - Neutropenia, febrile neutropenia in patients receiving intensive myelosuppressive cytotoxic chemotherapy for malignant diseases (with the exception of chronic myeloid leukemia and myelodysplastic syndrome) - Neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by allogeneic or autologous bone marrow transplantation, with an increased risk of developing prolonged and severe neutropenia; - Neutropen in patients with acute myelogenous leukemia receiving induction or consolidation chemotherapy to reduce its duration and clinical consequences - Mobilization of peripheral blood stem cells (autologous PSKK), including after myelosuppressive therapy, as well as mobilization of peripheral blood stem cells in healthy donors (allogeneic PSKK) - Severe congenital, periodic or idiopathic neutropenia (absolute number of neutrophils (ACN) ≤ 0.5 * 109/ l) in patients with severe or recurrent infections in the history to increase the number neutrophils, as well as to reduce the frequency and duration of infectious complications; - Persistent neutropenia (AFN ≤ 1.0 * 109/ l) in patients with developed stage of HIV infection to reduce the risk of bacterial infections when other methods of treatment are not available. "
2. In the section "Contraindications" indicate "hypersensitivity to the drug and its components in history, severe congenital neutropenia (Costman's syndrome) with cytogenetic disorders, concomitant administration with cytotoxic chemo- and radiotherapy, the drug should not be used to increase doses of cytotoxic chemotherapeutic drugs above the recommended ".
3. In the section "Caution", "patients with sickle-cell anemia, bone disease (including osteoporosis), with secondary acute myelogenous leukemia (due to limited safety and efficacy data), in the treatment of patients receiving high-dose chemotherapy." If the drug contains sorbitol, it is necessary to indicate - hereditary intolerance to fructose.