Instructions / Instruction for use: OctagamI want this, give me price
Dosage form: Solution for infusion
Active substance: Immunoglobulinum humanum normale
J06BA02 Normal human immunoglobulin for intravenous administration
The nosological classification (ICD-10)
C91 Lymphoid leukemia [lymphatic leukemia]: Lymphatic leukemia; Lymphoproliferative diseases; Neuroleukemia; Refractory acute lymphoblastic leukemia; Refractory lymphoblastic leukemia; Transformation of preleukemias; Chronic lymphocytic leukemia; Lymphoproliferative disorders
C92 Myeloid leukemia [myeloid leukemia]: Ph-positive chronic myelogenous leukemia; Granulocytic leukemia; Myeloid leukemia; Myeloid leukemia; Myeloma disease; Neuroleukemia; Acute myeloblastic leukemia; Acute non-lymphoblastic leukemia; Acute non-lymphoblastic leukemia in adults; Refractory acute non-lymphoblastic leukemia; Induction of remission in PMLL; Transformation of preleukemias; Subleukemic myelosis; Myeloblastic leukemia; Myeloid leukemia
D69.3 Idiopathic Thrombocytopenic Purpura: Werlhof's Disease; Idiopathic autoimmune thrombocytopenia; Idiopathic thrombocytopenic purpura of adults; Idiopathic thrombocytopenic purpura in adults; Immune idiopathic thrombocytopenic purpura; Immune thrombocytopenia; Bleeding in patients with thrombocytopenic purpura; Evans Syndrome; Thrombocytopenic purpura; Thrombocytopenia of immune origin; Chronic idiopathic thrombocytopenic purpura; Essential thrombocytopenia; Autoimmune thrombocytopenic purpura in pregnancy; Posttransfusion purpura
D84.9 Unspecified Immunodeficiency: Pneumonia in immunodeficient states; Autoimmune disease; Autoimmune diseases; Severe immunodeficiency; immune deficiency; Immunodeficiency; immunodeficiency diseases; Immunodeficiency states due to surgery; Immunotherapy for cancer; Immunomodulation; Infections in patients with weakened immune systems; Correction of immune deficiency; Correction of immunodeficiencies; Correction of a weakened immune system; Correction of a weakened immunity in immunodeficient states; Violation of immunity; Violation of the immune status; Immune System Disorders; Primary immunodeficiency; Maintaining immunity; Lowering the body's defenses; Lowering the immunity; Lowering the immunity of colds and infectious diseases; The decrease of the immune status; Lowered resistance to infections; Lowered resistance to infections and colds; Lowered resistance; Immunosuppression; Predisposition to colds; acquired immune deficiencies; Radiation immunodeficiency; The development of immunodeficiency; Immune dysfunction syndrome; immunodeficiency syndrome; primary immunodeficiency syndrome; Reducing the body's defenses; Immunosuppression; Reduced immune defense; Reducing local immunity; Reducing the total body resistance; The decrease in cell-mediated immunity; Reduced resistance to infections in children; Reducing the body's resistance; Reduced resistance; reduced immunity; Status immunodeficiency; Stimulation of the processes of nonspecific immunity; Heavy selective secondary immunodeficiency; immunity Oppression; Primary immunodeficiency
Composition and release form
1 ml of the infusion solution contains 50 mg of protein, at least 95% of which is human normal immunoglobulin G, and immunoglobulins A and M are less than 100 μg; In vials of 20, 50, 100 and 200 ml (with the content of immunoglobulin G 1, 2.5, 5 and 10 g respectively).
Human normal SD virus-inactivated immunoglobulin G for iv administration.
Mode action - immunomodulating.
Replenishes the deficit of immunoglobulins. It contains mainly immunoglobulin G with a wide spectrum of specific antibodies against many microorganisms endemic for Europe and North America.
Indications for the preparation Octagam
Substitution therapy: primary immunodeficiency syndrome (congenital agammaglobulinemia and hypogammaglobulinemia, unclassifiable variable and severe combined immunodeficiencies, Wiskott-Aldrich syndrome), secondary hypogammaglobulinemia in patients with chronic lymphocytic leukemia and myeloma, accompanied by repeated infections. Immunomodulatory therapy: idiopathic thrombocytopenic purpura with a high risk of bleeding or before surgery (to adjust the number of platelets), Kawasaki disease, bone marrow transplant.
Intolerance to homologous immunoglobulins, especially immunoglobulin A.
Increased body temperature, chills, a feeling of cold and cold sweat; Headache, dizziness, weakness, drowsiness; Nausea, hiccough, increased salivation; back pain; A flush of blood to the face, a slight decrease or increase in blood pressure, palpitations; Dry cough, shortness of breath; erythema; Anaphylactoid reactions (anaphylactic shock, etc.).
Dosing and Administration
IV, infuzionno (at a rate of 0.75-3 ml / min). Doses and duration of therapy are set individually. When substitution therapy for primary immunodeficiency is administered 0.4-0.8 g / kg (initial dose), then 0.2 g / kg every 3 weeks (after 3-6 months, the level of immunoglobulin G in the blood is 4-6 g / L). The dose required to achieve a level of 6 g / l is 0.2-0.8 g / kg / month, secondary immunodeficiency - 0.2-0.4 g / kg every 3-4 weeks. Thrombocytopenic purpura (treatment of acute episodes) - 0.8-1 g / kg, with repetition if necessary on day 3 or 0.4 g / kg / day for 2-5 days, Kawasaki disease - 1.6-2 g / Kg for 2-5 days (on the background of taking aspirin), bone marrow transplantation - 0.5 g / kg / week for 90 days after transplantation.
Storage conditions of the drug Octagam
In the dark place at a temperature of 2-25 ° C. (Do not freeze).
Keep out of the reach of children.
Shelf life of the drug Octagam
Do not use after the expiry date printed on the package.