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

    1 ml of the preparation contains:

    Active ingredient: human immunoglobulin in a protein concentration of 95 to 105 mg / ml.

    Excipients: aminoacetic acid (glycine) from 15 to 30 mg / ml, water for injection up to 1 ml.

    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:

    Immunologically active agent obtained by fractionating human plasma, tested individually from each donor for the absence of antibodies to HIV-1, HIV-2, to hepatitis C virus and the surface antigen of hepatitis B virus. The drug contains active antibodies of different specificity to the antigens of infectious agents. The drug also increases the nonspecific resistance of the body.

    Pharmacokinetics:

    The maximum concentration of antibodies in the blood is reached 24-48 hours after introduction; the half-life of antibodies from the body is 4-5 weeks.

    Indications:

    Deficiency of antibodies (primary and secondary).

    Heavy bacterial-toxic and viral infections, surgical infections accompanied by bacteremia and septicemia, prevention and treatment of infections in preterm infants.

    Hepatitis A, measles, influenza, whooping cough, meningococcal infections, poliomyelitis (prevention).

    Increase of the body's immune forces during the reconvalescence after infectious diseases.

    Contraindications:

    Contraindications for the use of immunoglobulin are severe allergic reactions in the history of the administration of human blood products.

    Persons with allergic diseases or having a history of clinically expressed reactions to any allergens (food, medicinal, etc.) on the day of immunoglobulin administration and for the next 8 days are recommended the appointment of antihistamines.

    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 antibodiesnewborn.

    Dosing and Administration:

    Enter intramuscularly into the upper outer quadrant of the gluteus muscle or 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. Opening of ampoules and the procedure of administration are carried out with strict adherence to aseptic and antiseptic rules. 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 immunoglobulin 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; 7-10 years - 1.5 ml; older than 10 years and adults - 3.0 ml.

    Repeated administration of immunoglobulin if necessary hepatitis A is not shown before 2 months later.

    Prevention of measles

    The drug is administered once from 3 months of age not 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 ml) is set depending on the condition health and time that has passed since the moment of contact.Adults, and also children, in contact with mixed infections, the drug is administered in a dose of 3 ml.

    Prevention of influenza

    The drug is administered once in doses: for children under 2 years - 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 dosage is indicated.

    Prophylaxis of pertussis

    Not sick with pertussis children the drug is administered twice with an interval of 24 hours in a single dose of 3 ml at the earliest possible time after contact with the patient.

    Prevention of meningococcal infection

    The drug is administered once to children aged from 6 months to 7 years, no later than 7 day after contact with the patient with a generalized form of meningococcal infection in doses of 1.5 ml (children under 3 years old) and 3 ml (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 in children

    The drug is administered in a dose of 1.0 ml per kg of body weight; The calculated dose can be entered into 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 in the period of 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:

    If, when using the drug, all recommendations for administration, dosage and precautions are met, reactions to immunoglobulin administration are generally not available.

    In rare cases, there may be hyperemia at the injection site and an increase in temperature to 37 ° C during the first 24 hours after the administration.

    Individuals with altered reactivity may develop allergic reactions of various types, in exceptional cases - anaphylactic shock, and therefore persons receiving the drug should be under medical supervision for 30 minutes.

    Overdose:

    At present, no cases of drug overdose have been reported.

    Interaction:

    The drug can be used in conjunction with any other drugs, provided it is administered as a separate injection, without mixing with other drugs.

    Active immunization with living viral vaccines (against measles, mumps, etc.) should be delayed for up to three months after the last injection of immunoglobulin, since it can reduce the effectiveness of live vaccine. After vaccination against these infections, immunoglobulin should be administered no earlier than 2 weeks; If immunoglobulin is required before this time, vaccination against measles or mumps should be repeated.

    Special instructions:

    Treatment with immunoglobulin drugs reduces the effectiveness of vaccination, so vaccinations should be carried out no earlier than 2-3 months after the administration of immunoglobulin.

    Persons who suffer from allergic diseases or are 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.

    With the development of anaphylactoid reactions, antihistamines are used, glucocorticosteroids and adrenomimetics.Persons suffering from autoimmune diseases (blood diseases, connective tissue, nephritis and others) 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 results in a serological study (Coombs reaction).

    Immunoglobulins for intramuscular injection are categorically forbidden to be administered intravenously.

    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.

    The drug is not suitable for use in ampoules with broken integrity and labeling, with a change in physical properties (turbidity, intense staining, the presence of unbreakable flakes).

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

    The effect of immunoglobulin on the ability to perform work requiring increased attention and speed of psychomotor reactions has not been revealed.

    Form release / dosage:

    Solution for intramuscular injection, 1.5 ml / dose.

    Packaging:

    For 1.5-3 ml in an ampoule with a capacity of 2 and 5 ml for 10 pieces in 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.

    Transport by any kind of covered transport at temperature from 2 to 10 ° C.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N002723 / 01
    Date of registration:29.08.2008 / 22.09.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:SANGVIS SEC №2 СО СОЗ SANGVIS SEC №2 СО СОЗ Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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