Active substanceThe human immunoglobulin is normalThe human immunoglobulin is normal
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  • Dosage form: & nbspsolution for intramuscular injection
    Composition:

    Active substance: immunoglobulin;

    Excipients: glycine, sodium chloride, water for injection.

    Description:

    Transparent or slightly opalescent liquid, colorless or slightly yellow in color, without foreign inclusions. During storage a slight precipitate may appear, disappearing when the preparation is shaken at a temperature of (20 ± 2 ° C).

    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 human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus, and hepatitis B surface antigen.

    The active component of the drug is immunoglobulins, which have antibodies of different specificity. The drug also increases the nonspecific resistance of the body.

    Pharmacokinetics:

    The maximum concentration of antibodies in the blood is reached after 24 hours, the half-life of antibodies from the body is 4-5 weeks.

    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 hypo- and agammaglobulinemia, to increase the resistance of the organism in the period of convalescence of infectious diseases.

    Contraindications:

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

    In the case 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.

    Dosing and Administration:

    Immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteus muscle or to 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 avoid the formation of foam, the drug is drawn into a syringe 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, over 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 a 3-month-old age, not infected with measles and not vaccinated against this infection, no later than 6 days after contact with the patient. The dose of the drug to children (1.5 or 3.0) is determined depending on the state of health and the time that has elapsed since the moment of contact. Adults, as well as 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 - 1.5 ml, from 2 to 7 years - 3 ml, over 7 years and adults - 4.5-6 ml.

    In the treatment of severe forms of influenza, repeated (24-48 hours) administration of immunoglobulin at the same dosage is indicated.

    Prophylaxis of pertussis

    The drug is administered twice at an interval of 24 hours in a single dose of 3 ml to children who have not had pertussis, at the earliest possible time after contact with the patient.

    Prevention of meningococcal infection

    The drug is administered once in doses to children aged 6 months. up 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 up to 3 years and 3 ml for children over 3 years old.

    Prevention of poliomyelitis

    The drug is administered once in a dose of 3.0-6.0 ml of non-grafted 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 agammaglobulinemia

    The drug is administered in a dose of 1.0 ml per kg of body weight, the calculated dose can be administered in 2-3 doses at an interval of 24 hours. The subsequent administration of immunoglobulin is carried out according to the indications no earlier than 1 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, the intervals between injections are 2-3 days.

    Side effects:

    In rare cases, reactions may occur in the form of hyperemia and an increase in temperature to 37.5 ° C during the first 24 hours after the administration, as well as dyspeptic events. 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.

    Rarely expressed depression of blood pressure, collapse, loss of consciousness, hyperthermia, chills, sweating, fatigue, malaise, back pain, myalgia, numbness, fever or cold sensation, aseptic meningitis, acute necrosis of renal tubules.

    Local reactions: rarely - skin flushing at the injection site.

    Interaction:

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

    The introduction of immunoglobulin can weaken (for 1.5-3 months) the effect of live vaccines against such viral diseases as measles, rubella, mumps and chicken pox (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. A temporary increase in the content of injected antibodies in the patient's blood following the administration of an immunoglobulin may cause false positive reactions of serological samples.

    Do not use concomitantly with calcium gluconate in infants.

    Special instructions:

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

    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.

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

    Form release / dosage:Solution for intramuscular injection, 1.5 ml / dose.
    Packaging:

    In ampoules of 1.5 ml (1 dose) and 3.0 ml (2 doses).

    10 ampoules are packed in a pack of cardboard for consumer packaging along with instructions for use.

    Storage conditions:

    The drug is stored in a dry and dark place at a temperature of 2 to 10 ° C.

    Do not use drugs in ampoules with broken integrity or labeling,when the physical properties change (color change, cloudiness of solution, presence of non-breaking flakes), expired shelf life, if stored improperly.

    The drug should be stored in places inaccessible to children.

    Shipping performed by any kind of covered transport at a temperature of from 2 to 10 ° C.

    Shelf life:

    2 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-004315/08
    Date of registration:03.06.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Vologda Regional Blood Transfusion Station No.1 Vologda Regional Blood Transfusion Station No.1 Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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