Grastim solution for injections 0.3 mg/ml. 1ml. syringe №1

Description

Grastim solution Storage
active substance: filgrastim;

1 ml of solution contains human granulocyte colony-stimulating factor (G-CSF) 0.3 mg (30 million IU or 300 μg);

Excipients: sorbitol (E420), polysorbate 80, sodium acetate trihydrate, glacial acetic acid, water for injections.

Grastim solution Dosage form
Solution for injection.

Grastim solution Pharmacotherapeutic group
Cytokines and immunomodulators. Colony-stimulating factors. ATC code L0ZA A02.

Indication
Reducing the duration and reducing the incidence of neutropenia and febrile neutropenia in patients receiving cytotoxic chemotherapy for malignancies (except for chronic myelogenous leukemia and myelodysplastic syndrome);
reduction of the duration of neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by allogeneic or autologous bone marrow transplantation;
mobilization of peripheral blood stem cells (PSCC), including after myelosuppressive therapy;
long-term therapy to increase the number of neutrophils and reduce the frequency and duration of infectious complications in children and adults with severe hereditary, recurrent or idiopathic neutropenia and absolute neutrophil count ≤ 0.5 x 109 / l and severe or recurrent infections in the anamnesis;
reducing the risk of bacterial infections and treatment of persistent neutropenia (absolute neutrophil count ≤1 x 109 / l) in patients with advanced HIV infection with ineffective other means of controlling neutropenia;
mobilization of peripheral blood stem cells (PSCC) in healthy donors for allogeneic PSCC transplantation.

Contraindication
Hypersensitivity to filgrastim, colony-stimulating factors, Escherichia coli or to any of the excipients.
Severe hereditary neutropenia (Costman’s syndrome) with cytogenetic disorders and autoimmune neutropenia.
Terminal stage of CRF.
Chronic myelogenous leukemia and myelodysplastic syndrome.

Method of application and dosage
Grastim® therapy can be performed in medical institutions where the necessary diagnostic equipment is available. Physicians should have experience in the use of drugs containing granulocyte colony-stimulating factor (G-CSF) and in the treatment of patients with hematological diseases.

Mobilization and apheresis procedures should be performed in collaboration with physicians who have relevant experience and the ability to properly monitor hematopoietic progenitor cells.

Neutropenia in patients receiving cytotoxic chemotherapy for malignancies.