Active substanceThe human immunoglobulin is normalThe human immunoglobulin is normal
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  • Dosage form: & nbspsolution for intramuscular injection
    Composition:Immunoglobulin, aminoacetic acid (glycine), sodium chloride, water for injection.
    Description:

    Transparent or slightly opalescent liquid, colorless or slightly yellow in color. The appearance of a slight precipitate, which disappears when shaken, is allowed.

    Pharmacotherapeutic group:MIBP - globulin
    ATX: & nbsp

    J.06.B.A.02   Immunoglobulin normal human for intravenous administration

    Pharmacodynamics:

    The preparation is an immunologically active protein fraction containing a broad spectrum of antibodies isolated from human plasma or donor sera tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and the hepatitis B surface antigen. component of the drug are immunoglobulins, which have antibodies of different specificity.

    Pharmacokinetics:

    The maximum concentration of antibodies in the blood is reached after 24 hours, during the half-life of antibodies from the body is 4-5 weeks. The drug also increases the nonspecific resistance of the body.

    Indications:

    The drug is used only for the prescription of a doctor for the prevention of hepatitis A, measles, influenza, pertussis, meningococcal infection, poliomyelitis, treatment of hypogammaglobulinemia, to increase the resistance of the organism in the period of convalescence of infectious diseases.

    Contraindications:

    Contraindicated in the introduction of immunoglobulin to people who have a history of allergic reactions or severe systemic reactions to human blood products.

    In cases of severe sepsis, the only contraindication for the administration of immunoglobulin is an anaphylactic shock to human blood products in the anamnesis.

    Hypersensitivity (including maltose and sucrose), immunodeficiency IgA.

    Carefully:

    Severe heart failure, diabetes, kidney failure, pregnancy, lactation.

    Pregnancy and lactation:At pregnancy enter only under strict indications when the prospective benefit for the mother exceeds the potential risk for the fetus.

    Immunoglobulin penetrates into breast milk and can facilitate the transfer of protective antibodies to the newborn.

    Dosing and Administration:

    Immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteus muscle or the external surface of the thigh. Do not administer the drug intravenously.

    Before the injection, the ampoule with the drug is kept for 2 hours at room temperature (20 + 2) ° C. To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen.

    The drug in the opened ampoule is not subject to storage.

    The dose of the drug and the frequency of its administration depend on the indications for use.

    Prevention of hepatitis A

    The drug is administered once in doses: children from 1 to 6 years - 0.75 ml; up to 10 years - 1.5 ml; older than 10 years and adults - 3 ml. Repeated administration of immunoglobulin in case of need of prophylaxis of hepatitis A is shown not earlier than in 2 months.

    Prevention of measles

    The drug is administered once from 3 months of age not with measles and not vaccinated against infection no later than 6 days after contact with the patient. The dose of the drug to children (1.5 or 3.0 ml) is determined depending on the health status and the time elapsed since the contact.

    Adults, and also children in contact with mixed infections, the drug is administered in a dose of 3.0 ml.

    Prevention and treatment of influenza

    The drug is administered once in doses: children under 2 years of age -1.5 ml; from 2 to 7 years - 3.0 ml; older than 7 years and adults - 4,5-6,0 ml. In the treatment of severe forms of influenza, repeated (24-48 hours) administration of immunoglobulin at the same dose is indicated.

    Prophylaxis of pertussis

    The drug is administered two times at intervals of 24 hours in a single dose of 3.0 ml to children who have not had pertussis, at the earliest possible time of contact with the patient.

    Prevention of meningococcal infection

    The drug is administered once in doses to children aged 6 months to 7 years, no later than 7 days after contact with the patient with a generalized form of meningococcal infection in doses of 1.5 ml for children under 3 years and 3.0 ml for children over 3 years old.

    Prevention of poliomyelitis

    The drug is administered once in doses of 3.0-6.0 ml of an unvaccinated or inferiorly grafted poliomyelitis vaccine to children at the earliest possible time after contact with the patient with a paralytic form of poliomyelitis.

    Treatment of hypo- and agamoglobulinemia

    The drug is administered at a dose of 1.0 per kg of body weight; The calculated dose can be entered into 2-3 doses at intervals of 24 hours. The subsequent administration of immunoglobulin is carried out according to the indications no earlier than one month later.

    Increase of resistance of the organism during the reconvalescence of acute infectious diseases with prolonged course and with chronic and protracted pneumonia.

    The drug is administered in a single dose of 0.15-0.2 ml per 1 kg of body weight. Multiplicity of administration (up to 4 injections) is determined by the doctor; intervals between injections are 2-3 days.

    Side effects:

    In rare cases, reactions may occur in the form of hyperemia and a rise in temperature to 37.5 FROM during the first 24 hours after the administration, as well as dyspepsia.

    Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock.

    Headache, dizziness, migraine pain, nausea, vomiting, abdominal pain, diarrhea, arterial hypo- or hypertension, tachycardia, cyanosis, chills, dyspnea, a feeling of constriction or pain in the chest, allergic reactions.

    Interaction:

    The introduction of immunoglobulins can weaken (during 1.5-3 months) the action of live vaccines against such viral diseases as measles, rubella, mumps and chickenpox (vaccinations with these vaccines should be repeated no earlier than 3 months). After the administration of large doses of immunoglobulin, its effect can last in individual cases up to one year.

    Temporary increase of the content of introduced antibodies in the blood of the patient after the administration of immunoglobulin can cause false positive results of serological tests.

    Do not use concomitantly with calcium gluconate in infants.

    Special instructions:

    Introduction of immunoglobulin and preventive vaccinations. Treatment with immunoglobulin drugs reduces the effectiveness of vaccination, so vaccinations are carried out, not earlier than 2-3 months after the administration of immunoglobulin.

    Persons with allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions on the day of immunoglobulin administration and for the next 8 days are recommended to prescribe antihistamines. In the period of aggravation of the allergic process, the drug is administered by the conclusion of an allergist.

    Persons suffering from autoimmune diseases (blood diseases, connective tissue, nephritis, etc.) should be given the drug on the background of appropriate therapy.

    Temporary elevation of antibodies in the blood after administration leads to false-positive analysis data in a serological study (Coombs reaction).

    Immunoglobulins for the / m introduction is strictly forbidden to enter IV. After the administration of the drug, the patient should be monitored for at least 30 minutes. In the room where the drug is administered, there should be antishock therapy. With the development of anaphylactoid reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

    Form release / dosage:Solution for intramuscular injection, 10%.
    Packaging:

    In ampoules of 3.0 ml (2 doses).

    10 ampoules are packed in a pack of cardboard box together with instructions for use.

    Storage conditions:

    The drug is stored in a dry and dark place at a temperature of 2 to +8 ° C.

    Shelf life:

    2 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000042
    Date of registration:16.03.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:LIPETSK REGIONAL STATION OF BLOOD TRANSFUSION LIPETSK REGIONAL STATION OF BLOOD TRANSFUSION Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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