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Dosage Form
Infusion solution.
Main physicochemical properties: a clear or slightly opalescent, colorless or slightly yellowish liquid.
Pharmacological Group
Human immunoglobulin normal for intravenous administration.
Indications
The medicinal product is to be used in adults, children, and adolescents for replacement immunotherapy in the treatment of primary and secondary immunodeficiency states and related diseases:
• Primary immunodeficiency syndromes: congenital agammaglobulinemia or hypogammaglobulinemia, severe combined immunodeficiency, unclassified variable immunodeficiency, Wiskott-Aldrich syndrome;
• Secondary antibody deficiency syndrome: cytopenias of various origins (acute and chronic leukemia, aplastic anemia, post-chemotherapy state), severe forms of bacterial-toxic and viral infections (including surgical complications accompanied by bacteremia and septic-pyemic conditions and complications in preparing surgical patients for surgery);
• Autoimmune diseases: idiopathic thrombocytopenic purpura with a high risk of bleeding or prior to surgical intervention - for correcting platelet count, Guillain-Barré syndrome, chronic inflammatory neuropathy (demyelinating), inflammatory myopathy, degenerative tissue, Kawasaki syndrome;
• Bone marrow transplantation.
Replacement therapy in adults, children, and adolescents (0 – 18 years) for:
• Primary immunodeficiency syndromes (PID) with impaired antibody production;
• Secondary immunodeficiencies (SID) in patients suffering from severe or recurrent infections, ineffective antimicrobial treatment, or in cases where specific antibody deficiency (SAD*) or serum IgG level <4 g/L is proven.
*SAD – inability to achieve at least a twofold increase in the IgG titer against pneumococcal polysaccharide and vaccines against polypeptide antigens.
To be used as part of combination therapy in adult patients with severe pneumonia caused by coronavirus infection COVID-19/SARS-CoV-2.
Storage Conditions
Store in the original packaging to protect from light at a temperature between 2°C and 8°C. Do not freeze. If stored at a temperature not exceeding 25°C, the shelf life is 6 months.
Infusion solution.
Main physicochemical properties: a clear or slightly opalescent, colorless or slightly yellowish liquid.
Pharmacological Group
Human immunoglobulin normal for intravenous administration.
Indications
The medicinal product is to be used in adults, children, and adolescents for replacement immunotherapy in the treatment of primary and secondary immunodeficiency states and related diseases:
• Primary immunodeficiency syndromes: congenital agammaglobulinemia or hypogammaglobulinemia, severe combined immunodeficiency, unclassified variable immunodeficiency, Wiskott-Aldrich syndrome;
• Secondary antibody deficiency syndrome: cytopenias of various origins (acute and chronic leukemia, aplastic anemia, post-chemotherapy state), severe forms of bacterial-toxic and viral infections (including surgical complications accompanied by bacteremia and septic-pyemic conditions and complications in preparing surgical patients for surgery);
• Autoimmune diseases: idiopathic thrombocytopenic purpura with a high risk of bleeding or prior to surgical intervention - for correcting platelet count, Guillain-Barré syndrome, chronic inflammatory neuropathy (demyelinating), inflammatory myopathy, degenerative tissue, Kawasaki syndrome;
• Bone marrow transplantation.
Replacement therapy in adults, children, and adolescents (0 – 18 years) for:
• Primary immunodeficiency syndromes (PID) with impaired antibody production;
• Secondary immunodeficiencies (SID) in patients suffering from severe or recurrent infections, ineffective antimicrobial treatment, or in cases where specific antibody deficiency (SAD*) or serum IgG level <4 g/L is proven.
*SAD – inability to achieve at least a twofold increase in the IgG titer against pneumococcal polysaccharide and vaccines against polypeptide antigens.
To be used as part of combination therapy in adult patients with severe pneumonia caused by coronavirus infection COVID-19/SARS-CoV-2.
Storage Conditions
Store in the original packaging to protect from light at a temperature between 2°C and 8°C. Do not freeze. If stored at a temperature not exceeding 25°C, the shelf life is 6 months.
