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indications:
Prophylaxis and treatment of infections in patients with primary immunodeficiency syndromes, prophylaxis and treatment of infections in patients with secondary immunity syndromes (chronic lymphocytic leukemia, AIDS, bone marrow transplant recipients, immunosuppressive treatment, etc.), treatment of idiopathic thrombocytopenic purpura (ITP), treatment of the syndrome Kawasaki, treatment of serious bacterial infections (sepsis) and viral infections, prevention and prevention of infections in premature infants and newborns with low birth weight, treatment of immune-mediated diseases (autoimmune hemolytic anemia, autoimmune neutropenia, immune-derived thrombocytopenia, Guillain-Barré syndrome, chronic inflammatory demyelinating polioneuropatia, myasthenia gravis), induction of immune tolerance in patients with haemophilia A with circulating anticoagulant, prevention of recurrent spontaneous abortion.
Composition:
1 ml contains 50 mg of human, unmodified immunoglobulin with 95% purity.
Action:
The preparation is a highly purified concentrate of modified human immunoglobulin (IgG). To enable its intravenous administration and avoid the intramuscular IgG aggregates and IgA and IgM impurities characteristic of intramuscular preparations (possible antigenic stimulation and deadly anaphylactic reactions), disulfide bridges between the immunoglobulin molecule chains break down during the sulfitolysis process. After intravenous administration, in the oxidation process, the cleaved chains are recombined by reconstituting a full, unchanged IgG molecule. As a result, the preparation contains a 7S immunoglobulin concentrate with a typical distribution of specific antibodies, but with a disordered division into IgG subclasses (no IgG3, a significant reduction of IgG4, an increase - IgG1, retained amount of IgG2). It exerts an immunomodulatory effect. T0,5 is about 22 days. Current methods of production of immunoglobulin concentrates inactivate HBV, HCV and HIV 1 and 2, HTLV I and II and others.
Contraindications:
Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency who have antibodies against IgA.
Precautions:
Pregnancy and lactation:
Side effects:
Gammaglobulin should not be given with any medicine and should always be given via a separate infusion set. Intravenous immunoglobulin reduces the effectiveness of active immunization, therefore live virus vaccines should be administered at least 6 weeks after administration of gamma globulin. After administration of immunoglobulin, the transient increase in passively transmitted antibodies in the patient's blood may lead to false positive serological tests.
Dosage:
The preparation for intravenous administration. Serve very slowly. Dosage of the preparation depends on the diagnosis and clinical condition of the patient, the dose should be selected individually. Primary immunodeficiency - once 0.2-0.8 g / kg m.c. every 3-4 weeks; secondary immunodeficiency syndromes - once 0.2-0.4 g / kg m.c. every 3-4 weeks; in bone marrow recipients 0.5 g / kg m.c. once 7 days before surgery, then every week for the first 3 months after surgery and every month for the Next 9 months; spontaneous thrombocytopenic purpura 0.4-1 g / kg m.c. for 3-5 days, then 0.4-1 g / kg m.c. at intervals of 1-4 weeks; Kawasaki team 1.6-2 g / kg m.c. in divided doses for 2-4 days, usually as an add-on to treatment with Acetylsalicylic acid preparations; Severe bacterial (sepsis) and viral infections - 0.4-1.0 g / kg m.c. for 1-4 days; prevention of infections of premature infants and infants with low birth weight 0.5-1.0 g / kg m.c. every 1-2 weeks; Guillain-Barré syndrome - 0.4g / kg m.c. for 5 days, then every 4 weeks.
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