Instruction for use: Immunoglobulin human normal

Trade name of the drug – Biaven V.I., Gabreglobine, Gabreglobine, Gamimune N, Hamunex, Hamunex-C, IG VENA N.I.V., IG VENA, Imbioglobulin, Immunovenin, Immunoglobulin, Immunoglobulin Segardis, Immunoglobulin Segardis MT, Human immunoglobulin donor antitroviral for enteral administration, Immunoglobulinum humanum normale, Intraglobin, Intratect, Octagam® 10%, Octagam, Privigen, Sandoglobulin, Flebogamma 5%,Humaglobin, Endobulin

The Latin name of the substance Immunoglobulin human normal

Immunoglobulinum humanum normale (genus. Immunoglobulini humani normalis)

Pharmacological group:

Immunoglobulins

The nosological classification (ICD-10)

A41.9 Septicemia, unspecified: Septic diseases; Septicemia / bacteremia; Toxico-infectious shock; Endotoxin shock; Bacterial septicemia; Bacterial infections of severe course; Generalized infections; Generalized systemic infections; Infections generalized; Wound sepsis; Septiccopymia; Septic-toxic complications; Septicemia; Septic conditions; Septic shock; Septic condition; Septic shock

A49 Bacterial infection of unspecified site: Bacterial infection; Infectious diseases

B20-B24 Disease caused by human immunodeficiency virus [HIV]: Deployed stage of HIV infection; AIDS in children; HIV / AIDS infection; Infections with HIV; AIDS; Human Immunodeficiency Virus HIV-1; HIV-1 infection HIV infection; HIV

B34.9 Viral infection, unspecified: Viral infections; Infections viral; Viral respiratory tract infections; Viral infection

C91.1 Chronic lymphocytic leukemia: Chronic lymphatic leukemia with tumor-like growths; B-cell CLL; B-cell chronic lymphocytic leukemia; Chronic granulocyte leukemia; CLL; Chronic leukemia; Chronic lymphoblastic leukemia; Chronic B-cell lymphocytic leukemia

D66 Hereditary factor VIII deficiency: Congenital insufficiency of factor VIII; Hemophilia; Hemophilia A; Hemophilia classical; Deficiency of antihemophilic factor of blood VIII; Deficiency of the coagulation factor VIII; Inhibitory form of hemophilia A; Bleeding at hemophilia A; Hereditary hemophilia; Hereditary anomalies of antihemophilic factor VIII; Failure factor VIII; Insufficiency of coagulation factor VIII; Acquired hemophilia; Coagulopathies are hereditary

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

D72 Other disorders of white blood cells: Lymphocytopenia; Hereditary neutropenia

G61.0 Guillain-Barre Syndrome: Miller-Fisher Syndrome; Polyneuropathy is infectious idiopathic; Polyradiculoneuritis acute primary idiopathic; Poliradiculoneuropathy acute demyelinating Guillain Barre; Guillain-Barre-Strol syndrome; The Landry-Guillain-Barre Syndrome

G70 Myasthenia gravis and other disorders of the neuromuscular synapse: Myasthenic syndrome; Myasthenic syndromes; Myasthenia gravis; Myasthenic syndrome; Severe myasthenia gravis (Myasthenia gravis)

M30.3 Mucous-cutaneous lymphonodular syndrome [Kawasaki]: Pediatric polyarteritis; Kawasaki disease; Kawasaki Syndrome; Mucous-cutaneous lymphonodulary syndrome; Dermal-mucous lymphadenopathy; Lymphonodular pharyngitis

N96 Habitual miscarriage: Miscarriage; Habitual abortion; Habitual miscarriage

Pharmacology

Pharmacological action - Immunostimulating.

Increases the body's antibodies. With iv infusion bioavailability is 100%. Between the plasma and extravascular space, the drug is redistributed, with equilibrium being reached after about 7 days. In individuals with normal IgG content in the serum, the biological half-life period averages 21 days, while in patients with primary hypo- or agammaglobulinemia - 32 days. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndrome, provides the replacement of missing IgG antibodies, which reduces the risk of infection.

Application of the substance Immunoglobulin human normal

Substitution therapy for the prevention of infections in primary immunodeficiency syndromes: agammaglobulinemia, conventional variable immunodeficiencies associated with a- or hypogammaglobulinemia; Deficiency of IgG subclasses, substitution treatment for the prevention of infections in the syndrome of secondary immunodeficiency caused by chronic lymphocytic leukemia, AIDS in children or bone marrow transplantation, idiopathic thrombocytopenic purpura, Kawasaki syndrome (in addition to acetylsalicylic acid treatment), severe bacterial, including sepsis Combinations with antibiotics) and viral infections, prevention of infections in premature infants with low birth weight (less than 1500 g), Guillain-Barre syndrome and cron Inflammatory demyelinating polyneuropathy, autoimmune neutropenia, partial red cell aplasia of hemopoiesis, thrombocytopenia of immune origin, incl. Posttransfusion purpura, isoimmune thrombocytopenia of newborns, hemophilia caused by the formation of antibodies to coagulation factors, myasthenia gravis, the prevention and treatment of infections in the therapy of cytostatics and immunosuppressants, the prevention of habitual miscarriage.

Contraindications

Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.

Side effects of Immunoglobulin human normal

Headache, nausea, dizziness, vomiting, abdominal pain, diarrhea, arterial hypo- or hypertension, tachycardia, cyanosis, dyspnea, feeling of constriction or pain in the chest, allergic reactions; Rarely severe hypotension, collapse, loss of consciousness, hyperthermia, chills, increased sweating, tired feeling, malaise, back pain, myalgia, numbness, hot flashes or a feeling of cold.

Interaction

May decrease the effectiveness of active immunization: live viral vaccines for parenteral use should not be used for at least 30 days after the administration of immunoglobulin.

Routes of administration

IV, drop.

Precautions for the substance Immunoglobulin human normal

Most side effects are associated with a high infusion rate and can be stopped when the infusion is stopped or slowed. In case of serious side effects, administration should be discontinued (adrenaline, antihistamines, corticosteroids and plasma substitutes). In case of impaired renal function, it is recommended to monitor the condition of patients during treatment (control of creatinine - within 3 days after infusion). After the introduction of an immunoglobulin, the content of antibodies in the blood increases (passively), which can lead to an erroneous interpretation of the results of the serological test.