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

    1 dose (1.5 ml) contains:

    active substance: immunoglobulin (protein) - 0.15 g ((10 ± 0.5)%);

    auxiliary substanceso: glycine (aminoacetic acid) - 0.03 g (2%), water for injection up to 1.5 ml.

    Description:

    Transparent or slightly opalescent liquid, colorless or slightly yellow in color. There is the appearance of a slight precipitate, disappearing with shaking.

    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 wide range of antibodies isolated from human plasma or serum from healthy donors, tested for the absence of antibodies to human immunodeficiency virus / HIV (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 is an immunomodulating and immunostimulating agent. Contains a large number of neutralizing and opsonizing antibodies, due to which it effectively counteracts viruses, bacteria and other pathogens.Also, the product replenishes the number of missing IgG antibodies, thereby reducing the risk of infection in people with primary and secondary immunodeficiency. Immunoglobulin effectively replaces and replenishes natural antibodies in the patient's serum.

    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. The drug also increases the nonspecific resistance of the body.

    Indications:

    The drug is used only as directed by a doctor. It is used for replacement therapy if there is a need for replenishment and replacement of natural antibodies, for the prevention of hepatitis A, measles, influenza, whooping cough, meningococcal infection, poliomyelitis, infections, in the treatment of hypo - and agammaglobulinemia, bone marrow transplantation, chronic lymphocytic leukemia, with immunodeficiency of various nature, with AIDS in children, to increase the resistance of the organism in the period of convalescence of infectious diseases.

    Contraindications:

    Contraindicated the introduction of immunoglobulin to people who have a history of severe allergic reactions to blood products of man.

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

    Do not use the drug for hypersensitivity (including maltose and sucrose), with immunodeficiency IgA due to the presence of antibodies to it, with an exacerbation of the allergic process.

    Carefully:In severe heart failure, diabetes, kidney failure, with migraine, with diseases with immunopathological mechanisms (nephritis, collagenosis).
    Pregnancy and lactation:

    When pregnancy and lactation are administered only on strict indications, when the intended benefit for the mother exceeds the potential risk to the fetus and baby.

    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 preparations in ampoules with broken integrity or marking are not suitable for use in changing physical properties (color change, cloudiness of solution, presence of non-breaking flakes), expired shelf life, and improper storage.

    The dosage 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 the following amounts: children from 1 to 6 years - 0.75 ml (1/2 dose); from 7 to 10 years - 1.5 ml (1 dose); older than 10 years and adults - 3 ml (2 doses). Repeated administration of immunoglobulin according to indications - not earlier than in 2 months.

    Prevention of measles

    The drug is administered once, from 3 months of age, not measles and unvaccinated, no later than 4 days after contact with the patient. Dosage of the drug to children (1.5 or 3.0 ml) is determined depending on the state of health and the time elapsed from the time of contact with the patient. Adults, as well as children in contact with mixed infections, the drug is administered in a volume of 3.0 ml (2 doses).

    Prevention and treatment of influenza

    The drug is administered once in amounts: to children under 2 years - 1.5 ml (1 dose); from 2 to 7 years - 3.0 ml (2 doses); older than 7 years and adults - 4.5-6.0 ml (3-4 doses).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 injected twice with an interval of 24 hours in a single dose of 3.0 ml (2 doses) 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 to children aged 6 months to 7 years, not later than 7 days after contact with the patient, the generalized form of meningococcal infection at a dosage of 1.5 ml (1 dose) to children under 3 years and 3.0 ml (2 doses) - Children over 3 years.

    Prevention of poliomyelitis

    The drug is administered once in an amount of 3.0-6.0 ml (2-4 doses) 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 an amount of 1.0 ml per kg of body weight; The calculated dose can be administered in 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 dosage 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 interval between / injections is 2-3 days.

    Side effects:

    It is rarely noted, usually due to the high rate of administration of the drug, disappears with a decrease in the infusion rate and discontinuation of admission.

    Most likely the manifestation of effects at the first admission, during the first hour: influenza-like syndrome - malaise, chills, hyperthermia, weakness, headache.

    Reactions can occur in the form of skin hyperemia at the site of intramuscular administration (local reaction) and rise in temperature to 37.5 ° C during the first day after administration, as well as dyspepsia.

    Individuals with altered reactivity may develop allergic reactions of various types (rash, itching, bronchospasm), and in exceptional cases - anaphylactic shock. Nausea, vomiting, abdominal pain, diarrhea, increased salivation from the digestive system, headache, dizziness, migraine pain, weakness, drowsiness from the CNS, arterial hypo- or hypertension, tachycardia, cyanosis, a feeling of constriction or pain in the chest from the CCC, dry cough, hiccough, aching joints and back pain.

    Rarely - marked reduction of blood pressure or severe hypertension, breathlessness, collapse with loss of consciousness, fever or chills, sweating, fatigue, myalgia, numbness, CNS - aseptic meningitis with the kidneys - acute renal tubular necrosis, worsening renal failure patients with impaired renal function.

    Interaction:

    Introduction immunoglobulins may attenuate (over 1.5-3 months) effects of live vaccines against viral diseases such as measles, rubella, mumps and varicella (grafting these vaccines should be repeated no sooner than after three months. After the administration of large doses of immunoglobulin its influence can last in individual cases up to one year.

    Do not use concomitantly with calcium gluconate in infants.

    Immunoglobulin therapy can be combined with other drugs, particularly antibiotics in severe bacterial infections (sepsis).

    Special instructions:

    Introduction of immunoglobulin and preventive vaccinations

    Treatment immunoglobulin reduces the effectiveness of vaccination, so vaccination is 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.

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

    A temporary increase in antibody levels in the blood after administration leads to false positive results from the serological test (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 anaphylactic reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

    Form release / dosage:Solution for intramuscular injection.
    Packaging:

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

    10 ampoules in a pile of cardboard boxed.

    In each pack put the instructions for use and the ampoule opener.

    Storage conditions:

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

    Keep out of the reach of children.

    Transportation is carried out by any kind of covered transport, at a temperature of 2 to 10 FROM.

    Shelf life:

    2 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000373
    Date of registration:18.08.2011 / 11.12.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:IVANOV REGIONAL STATION OF BLOOD TRANSFUSION IVANOV REGIONAL STATION OF BLOOD TRANSFUSION Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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