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

    1 ampoule (3 ml of solution) contains:

    active substance: human immunoglobulin normal 300 mg;

    Excipients: glycine 60 mg, sodium chloride 27 mg, water for injection up to 3 ml.
    Pharmacotherapeutic group:MIBP - globulin
    ATX: & nbsp

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

    Pharmacodynamics:

    The human immunoglobulin normal contains IgG antibodies present in healthy individuals. The drug is produced from human blood plasma, obtained from no less than 1000 donors. The distribution of subclasses of immunoglobulin G in the preparation is closely proportional to their distribution in the native plasma of human blood. Adequate doses of normal human immunoglobulin can restore abnormally low levels of immunoglobulin G to the normal range. The mechanism of action for indications other than substitution therapy is not fully understood, but includes an immunomodulatory effect.

    Indications:

    Prevention of hepatitis A, measles, influenza, pertussis, meningococcal infection, poliomyelitis, treatment of hypo- and agammaglobulinemia, to increase the resistance of the organism during the reconvalescence 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.

    Carefully:

    Severe heart failure, diabetes, kidney failure.

    Pregnancy and lactation:

    During pregnancy or lactation, use for life indications, comparing the benefits to the mother and the risk to the fetus.

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

    Dosing and Administration:

    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 3 months of age to persons who are not infected with measles and not vaccinated against the infection, no later than 6 days after contact with the patient.The dose of the drug to children (1.5 or 3 ml) is determined depending on the health status and the time elapsed from the moment of contact. Adults, and also children, in contact with mixed infections, the drug is administered in a dose of 3 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 h) administration of immunoglobulin at the same dose is indicated.

    Prophylaxis of pertussis

    The drug is administered twice with an interval of 24 hours in a single dose of 3 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, not 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 ml for children over 3 years old.

    Prevention of poliomyelitis

    The drug is administered once in doses of 3-6 ml of an unvaccinated or inferiorly vaccinated 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 ml per 1 kg of body weight, the calculated dose can be administered in 2-3 doses at an interval of 24 h. Subsequent immunoglobulin administration is carried out according to indications no earlier than one month.

    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.

    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.

    Prior to the beginning of the administration, the ampoule with the preparation is kept for 2 hours at room temperature (18-22) ° 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.

    Persons receiving the drug should be monitored for 30 minutes; In the room where the drug is injected, anti-shock therapy should be available. With the development of anaphylactic reactions, antihistamines are used,glucocorticosteroids and adrenomimetics.

    Indication of the features of the drug during the first admission or when it is withdrawn

    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. 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.

    Side effects:

    With the introduction of possible: headache, pain, dizziness, migraine pain, abdominal pain, increase or decrease in blood pressure, tachycardia, cyanosis, chills, dyspnea, chest pain.

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

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

    Rarely expressed decrease in arterial pressure, collapse, loss of consciousness, increased sweating, tired feeling, malaise, back pain, myalgia, numbness, fever, or a feeling of cold,aseptic meningitis, acute necrosis of renal tubules.

    Overdose:

    Cases of overdose were not observed.

    Interaction:

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

    In infants, do not use together with calcium gluconate.

    Immunoglobulin should be administered no earlier than 3 months after immunization with live viral vaccines against measles, rubella, mumps, chicken pox.

    Special instructions:

    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.

    Effect on the ability to drive transp. cf. and fur:

    The introduction of the drug does not lead to psychomotor disorders and reactions and does not affect the ability to control transportmeans and other mechanisms.

    Form release / dosage:Solution for intramuscular injection, 100 mg / ml.
    Packaging:In ampoules. Instructions for medical use, knife ampoule (if necessary). A pack of cardboard.
    Storage conditions:

    In a dry, dark place at a temperature of 2 to 10 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LS-003125
    Date of registration:24.08.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:TAMBOV REGIONAL STATION OF BLOOD TRANSFUSION TAMBOV REGIONAL STATION OF BLOOD TRANSFUSION Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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