Instruction for use: Octagam

Dosage form: Solution for infusion

Active substance: Immunoglobulinum humanum normale

ATX

J06BA02 Normal human immunoglobulin for intravenous administration

Pharmacological groups:

Immunoglobulins

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).

Characteristic

Human normal SD virus-inactivated immunoglobulin G for iv administration.

Pharmachologic effect

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.

Contraindications

Intolerance to homologous immunoglobulins, especially immunoglobulin A.

Side effects

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

2 years.

Do not use after the expiry date printed on the package.