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

    1 dose contains:

    active substance: human immunoglobulin normal (protein concentration from 9.5 to 10.5%);

    auxiliary substance: stabilizer-glycine (aminoacetic acid) (2.25 ± 0.75)%.

    The drug does not contain preservatives and antibiotics.

    Description:

    Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, a slight deposit may appear, disappearing after a slight shaking.

    Pharmacotherapeutic group:MIBP - globulin
    ATX: & nbsp

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

    Pharmacodynamics:

    The preparation is a concentrated solution of an immunologically active protein fraction isolated by the method of fractionation with ethyl alcohol from the blood plasma of healthy donors. Each immunoglobulin series is made from a plasma mixture of no less than 1000 donors, individually tested for the absence of a surface antigen of the hepatitis B virusHBsAg), antibodies to the hepatitis C virus and human immunodeficiency virus HIV-1 and HIV-2.

    The drug contains a wide range of specific antibodies against infectious agents that are capable of opsonizing and neutralizing microbes and toxins. The introduction of the drug replenishes the level of antibodies in the blood of the recipient. The drug also has nonspecific activity, manifested in increasing the resistance of the body. The introduction of the drug restores low levels of immunoglobulin G up to normal values.

    Pharmacokinetics:

    The maximum concentration of antibodies in the blood is reached 24-48 hours after administration, the half-life of antibodies from the body is 3-4 weeks.

    Indications:

    - Prevention of hepatitis A, measles, whooping cough, meningococcal infection, poliomyelitis;

    - prevention and treatment of influenza;

    - treatment of hypo-and agammaglobulinemia;

    - increase of resistance of the organism in the period of reconvalescence of acute infectious diseases with prolonged course and with chronic pneumonia.

    Contraindications:

    - Hypersensitivity to human immunoglobulin, especially in rare cases of a deficiency in the blood of immunoglobulin class A (IgA) and the presence of antibodies against IgA;

    - hypersensitivity to the components of the drug;

    - presence in the anamnesis of allergic reactions to blood products of the person.

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

    Carefully:

    Persons with allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, administration of antihistamines is recommended on the day of immunoglobulin administration and for the next 8 days. During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.

    Persons suffering from diseases in the genesis of which the immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis) are leading, the drug is appointed after consultation of the relevant specialist.

    Use with caution in the following risk groups:

    - in patients older than 65 years;

    - in patients with severe heart failure;

    - in patients with renal insufficiency.

    Pregnancy and lactation:

    The safety of the drug during pregnancy and during breastfeeding during controlled clinical trials has not been studied.The use of the drug during pregnancy and during breastfeeding is possible only if the potential benefit to the mother exceeds the potential risk to the fetus and the baby. Immunoglobulins penetrate into breast milk and protective antibodies during breastfeeding can be transmitted from mother to child.

    Dosing and Administration:

    The drug is administered intramuscularly, in the upper outer quadrant of the gluteus muscle or in 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. 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 preparation is not suitable for use in ampoules with broken integrity, marking, and also when physical properties change (color change, cloudiness of solution, presence of unbreakable flakes), expired shelf life and non-observance of storage conditions.

    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 in case of need of prophylaxis of hepatitis A is shown not earlier than in 2 months.

    Prevention of measles. The drug is administered only once from 3 months of age to persons who are 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 ml) is determined depending on the health status and the time elapsed since the contact. Adults, as well as children in contact with mixed infections, the drug is administered in a dose of 3.0 ml.

    Prophylaxis of pertussis. The drug is injected twice with an interval of 24 hours in a single dose of 3.0 ml to children who have not had pertussis and who are not vaccinated (not fully vaccinated) against pertussis at the earliest possible time after contact with the patient, but not later than 3 days.

    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 with a generalized form of meningococcal infection at doses of 1.5 ml (children up to 3 years) and 3.0 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 a patient with poliomyelitis.

    Prevention and treatment of influenza. The drug is administered once at doses: children up to 2 years - 1.5 ml; from 2 up 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, a second 24-48 h) administration of immunoglobulin in the same dose.

    Treatment of hypo-and agammaglobulinemia. The drug is administered in a dose of 1.0 ml / 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 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 pneumonia. The drug is administered in a single dose of 0.15-0.2 ml / kg body weight. Multiplicity of administration (up to 4 injections) is determined by the attending physician, the intervals between injections are 2-3 days.

    Side effects:

    The incidence of side effects is determined as follows: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases).

    The following side effects are possible:

    General disorders and disorders at the site of administration:

    Often: soreness in the injection site.

    Rarely: chills, hyperthermia, weakness, hyperemia at the injection site.

    Immune system disorders:

    Very rarely: allergic reactions (hives, itching, rash), anaphylactic shock.

    Impaired nervous system:

    Very rarely: headache, dizziness.

    Disorders from the digestive system:

    Very rarely: nausea, vomiting.

    Disorders from the musculoskeletal system:

    Very rarely: pain in the back, joint pain.

    Violations from hand of cardio-vascular system:

    Rarely: lowering blood pressure.

    Overdose:

    No cases of drug overdose have been reported.

    Interaction:

    The drug can be used in complex therapy of the disease in combination with other drugs, in particular, with antibiotics. It is not allowed to mix the drug with other drugs in the same syringe.

    In infants, do not apply simultaneously with calcium gluconate.

    The introduction of immunoglobulin can reduce the effectiveness of active immunization, so live vaccines (against measles, mumps, rubella, chicken pox) should be administered no earlier than 3 months after the administration of the immunoglobulin.After vaccination against these infections, the immunoglobulin should be administered no earlier than 2 weeks; if immunoglobulin is required before this time, vaccination against measles, mumps, rubella, chicken pox should be repeated. Vaccinations against other infections can be carried out at any time before or after the administration of the immunoglobulin.

    In the case of measles vaccination, a decrease in the effectiveness of the vaccine is possible within 1 year after the administration of the immunoglobulin. In this regard, patients vaccinated with measles vaccine, it is recommended to monitor the level of antibodies.

    Special instructions:

    During the administration of the drug, the patient's condition should be carefully monitored. Persons receiving the drug should be under medical supervision for 30 minutes after the administration. Premises where the drug is administered should be provided with anti-shock therapy.

    The introduction of an immunoglobulin can lead to a transient increase in various passively transmitted antibodies in the patient's blood and to false positive results from serological tests (eg, Coombs test).

    The drug should be registered in the prescribed registration forms with the name of the drug, serial number, date of issue, expiration date, manufacturer, date of administration, dose and adverse reactions to the drug.

    Special precautions when destroying an unused preparation are not available.

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

    A drug not has an effect on the ability to drive vehicles, mechanisms, as well as the ability to perform actions that require increased concentration and speed of psychomotor reactions.

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

    For 1.5 ml (1 dose) or 3 ml (2 doses) in the ampoule.

    A) For 10 ampoules with instructions for use, a vial ampoule or scarifier ampullum in a pack (box) of cardboard.

    B) 5 ampoules in a cassette contour pack. 2 cassette contour packs with instructions for use in a pack of cardboard.

    When packaging ampoules that have a break ring or an opening point, the ampoule knife or the ampoule scapegrator is not put in.

    Storage conditions:

    Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C out of the reach of children. Freezing is not allowed.

    Transport in accordance with SP 3.3.2.1248-1) 3 at a temperature of 2 to 8 ° C. Freezing is not allowed.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001544 / 01
    Date of registration:08.07.2008 / 03.06.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp24.10.2017
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