The human immunoglobulin is normal (Immunoglobulinum humanum normale)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceThe human immunoglobulin is normalThe human immunoglobulin is normal
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    • Dosage form: & nbspsolution for infusions
    Composition:

    In 25 ml of the drug contains:

    Immunoglobulin G -

    1.25 g

    glycine-

    0.125 g

    sodium chloride -

    0.175 g

    glucose -

    0.25 g

    water for injections -

    up to 25 ml
    Description:

    Transparent or slightly opalescent solution, colorless or light yellow in color.

    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 blood plasma from donors tested for the absence of antigen and antibodies to human immunodeficiency virus (HIV-1 and HIV-2), hepatitis C virus and hepatitis B surface antigen. Active component of the drug is immunoglobulin G, possessing the activity of antibodies of different specificity. The drug also has nonspecific immunoregulatory activity, which manifests itself in increasing the body's resistance and anti-inflammatory action.

    The drug is devoid of anticomplementary properties.
    Pharmacokinetics:

    With intravenous infusion, bioavailability is 100%.The maximum concentration of antibodies in the blood is kept up to 14 days. The half-life of antibodies from the body is 4-5 weeks.

    The drug passes through the placenta and penetrates into breast milk.

    Indications:

    Treatment of severe forms of bacterial and viral infections.

    Treatment of postoperative complications, accompanied by bacteremia and septicopyemic conditions.

    Primary syndrome of antibody deficiency agamma and hypogammaglobulinemia (congenital form, period of physiological deficit in newborns). Secondary antibody deficiency syndrome.

    Diseases of the blood, the consequences of immunosuppressive therapy, the syndrome of acquired immunodeficiency (AIDS), especially when infecting children with human immunodeficiency virus.

    Contraindications:

    Allergic reactions or severe systemic reactions to human blood products in the anamnesis.

    In cases of severe sepsis, the only contraindication is an anaphylactic shock to a person's blood products in an anamnesis.

    Immunodeficiency IgA.

    Carefully:

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

    Dosing and Administration:
    Immunoglobulin for infusion is used only in a hospital. Before administration, the vials are kept at a temperature of (20 ± 2) ° C for at least 2 hours. Muddy and sediment-free solutions are not applicable.

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

    For children a single dose of the drug is 3-4 ml per 1 kg of mass, but not more than 25 ml. The speed of infusion and the duration of therapy are selected individually by the physician. Immediately prior to administration, the drug is diluted with 0.9% sodium solution chloride or 5% glucose solution, based on: 1 part of the preparation and 4 parts of the diluent. The diluted immunoglobulin is administered intravenously at a drop rate of 8-10 drops per minute. Infusions are carried out daily for 3-5 days.

    For adults a single dose of the drug is 25-50 ml. Immunoglobulin (without additional dilution) is administered intravenously drip at a rate of 30-40 drops per minute. The course of treatment consists of 3-10 transfusions, conducted in 24-72 hours (depending on the severity of the disease).

    Side effects:

    Reactions to the introduction of immunoglobulin, as a rule, are absent.

    Local adverse reactions are skin hyperemia at the injection site.During the first day after the administration of the drug, an increase in temperature up to 37.5 ° C, allergic reactions up to anaphylactic shock are possible.

    In a number of cases (less than 1 in 100 prescriptions), headache, dizziness, dyspeptic phenomena, abdominal pain, arterial hypo- or hypertension, tachycardia, cyanosis, dyspnea occur.

    Rare adverse reactions - a marked decrease in blood pressure, collapse, loss of consciousness, chills, myalgia.

    Overdose:

    Cases of drug overdose are not described.

    Interaction:

    Therapy with immunoglobulin can be combined with other drugs, in particular, antibiotics.

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

    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 conducted no 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.

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

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

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

    The recommended rate of administration should be observed. A faster injection can cause the development of a collapoid reaction.

    Form release / dosage:Solution for infusion.
    Packaging:

    In bottles of 25 ml (1 dose).

    Each bottle together with instructions for use placed in a pile of cardboard boxed.

    Storage conditions:

    The preparation is stored in a dry, dark place at a temperature of 2 to 8 ° C. The drug should be stored in places inaccessible to children.

    Transportation is carried out by any kind of covered transport at a temperature of 2 to 8 ° C.

    Shelf life:

    1 year.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003765/08
    Date of registration:16.05.2008 / 13.06.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Nizhny Novgorod Regional Blood Center. N. Ya. KlimovaNizhny Novgorod Regional Blood Center. N. Ya. Klimova Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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