What are immunoglobulins and what are they for? Normal human immunoglobulin, solution for intramuscular injection

Replacement therapy for the prevention of infections in primary immunodeficiency syndromes: agammaglobulinemia, common variable immunodeficiencies associated with a- or hypogammaglobulinemia; deficiency of IgG subclasses, replacement therapy to prevent infections in secondary immunodeficiency syndrome due to chronic lymphocytic leukemia, AIDS in children or bone marrow transplantation, idiopathic thrombocytopenic purpura, Kawasaki syndrome (in addition to treatment with acetylsalicylic acid drugs), severe bacterial infections, including sepsis (in combinations with antibiotics) and viral infections, prevention of infections in premature infants with low birth weight (less than 1500 g), Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy, autoimmune neutropenia, partial red cell aplasia of hematopoiesis, thrombocytopenia of immune origin, incl. h. post-transfusion purpura, neonatal isoimmune thrombocytopenia, hemophilia caused by the formation of antibodies to coagulation factors, myasthenia gravis, prevention and treatment of infections during therapy with cytostatics and immunosuppressants, prevention of recurrent miscarriage.

Contraindications Human immunoglobulin normal solution for intramuscular injection 1.5ml/dose 1 dose

During the first days after the administration of the drug, a slight increase in body temperature, allergic reactions are possible. Sometimes there is a headache, dizziness, dyspeptic symptoms, arterial hypo- or hypertension, tachycardia, shortness of breath. In extremely rare cases, with individual intolerance, the development of anaphylactic reactions is possible. Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.

Method of administration and dosage Human immunoglobulin normal solution for intramuscular injections 1.5ml/dose 1 dose

In / in, drip. The dosage regimen is set individually, depending on the indications, the severity of the disease, the state of the immune system, and individual tolerance. With primary and secondary immunodeficiency syndromes, a single dose is 0.2-0.8 g / kg (average - 0.4 g / kg); administered at intervals of 2-4 weeks (to maintain minimal levels of IgG in blood plasma, constituting 5 g / l). For the prevention of infections in patients undergoing bone marrow allotransplantation, 0.5 g / kg once a day for 7 days before transplantation, and then 1 time per week for the first 3 months after transplantation, and 1 time per month for the next 9 months. With idiopathic thrombocytopenic purpura - 0.4 g / kg for 5 days in a row; in the future (if necessary) - 0.4 g / kg at intervals of 1-4 weeks to maintain a normal level of platelets. With Kawasaki syndrome - 0.6-2 g / kg in several doses for 2-4 days. In severe bacterial infections (including sepsis) and viral infections - 0.4-1 g / kg daily for 1-4 days. For the prevention of infections in premature infants with low birth weight - 0.5-1 g / kg with an interval of 1-2 weeks. With Guillain-Barré syndrome and chronic inflammatory demyelinating neuropathy - 0.4 g / kg for 5 days; if necessary, 5-day courses of treatment are repeated at intervals of 4 weeks.

Human immunoglobulin refers to immunological preparations. It is a concentrated solution of an immunologically active protein fraction, which is isolated from the blood plasma of healthy donors by fractionation with ethyl alcohol at a temperature below 0°C.

The Yusupov hospital has all the necessary conditions for the treatment of patients. In the therapy clinic, comfortable wards are equipped with exhaust ventilation and air conditioning. This allows you to provide a comfortable temperature. Professors and doctors of the highest category are the leading immunologists.

Examination of patients is carried out using modern equipment. For the treatment of patients, immunoglobulins registered in the Russian Federation are used. They are highly effective and have a minimal range of side effects. Patients are provided with individual personal hygiene products and dietary nutrition.

For the manufacture of one series of immunoglobulin, manufacturers use plasma obtained from at least 1000 healthy donors. They are preliminarily individually checked for the absence of the surface antigen of the hepatitis B virus, antibodies to the hepatitis C virus and human immunodeficiency viruses.

Instructions for use of human immunoglobulin

The active substance of normal human immunoglobulin are immunoglobulins that contain antibodies of various specificities. The preparation contains from 9.5 to 10.5% protein. The maximum concentration of antibodies in the blood is determined 24-48 hours after the administration of the drug. The half-life of antibodies is 4-5 weeks.

Normal human immunoglobulin (instruction is in the box) is available as a solution in 1.5 ml ampoules (1 dose). One package may contain 5, 10 or 20 ampoules of the drug. The ampoule file is included in the package. The drug is released in pharmacies by prescription. Immunoglobulin in ampoules is transported and stored at air temperature from +2 to +8 o C.

How to inject immunoglobulin? Inject immunoglobulin intramuscularly into the outer upper quadrant of the buttock or the anterior surface of the thigh. The drug is not administered intravenously. The nurses of the Yusupov hospital strictly observe the rules of asepsis and antisepsis when performing immunoglobulin injections. Before injection, the ampoules with human immunoglobulin are kept for two hours at room temperature.

In order to prevent foam from forming in the syringe, the drug is drawn into the syringe with a needle with a wide lumen. Enter it by changing the needle. The drug in the opened ampoule is not subject to storage. In the Yusupov hospital, patients are not injected with immunoglobulin if the integrity or labeling of the ampoules is broken. The drug is unsuitable for use if the solution is cloudy, discolored, the presence of non-breakable flakes, as well as immunoglobulin, which was stored in improper conditions or expired.

Indications and contraindications for the use of human immunoglobulin

Doctors at the Yusupov Hospital use normal human immunoglobulin to prevent various infectious diseases:

  • hepatitis A;
  • whooping cough;
  • measles;
  • meningococcal infection;
  • flu;
  • poliomyelitis.

The drug is used to treat patients suffering from hypoglobulinemia and agammaglobulinemia. After the introduction of normal human immunoglobulin, the overall resistance of the body increases during the recovery period of patients with infectious diseases.

Contraindications to the use of human immunoglobulin are severe allergic reactions to the administration of blood products in the past (allergic rashes, Quincke's edema, anaphylactic shock). Do not use the drug in patients suffering from systemic immunopathological diseases - connective tissue diseases, blood pathology, nephritis. The use of a simple immunoglobulin is contraindicated in thrombocytopenia and other disorders of the blood coagulation system.

Doses of human immunoglobulin

Doctors select the dose of human immunoglobulin and the frequency of its administration, depending on the indications for use. In order to prevent hepatitis B, the drug is administered once in the following doses:

  • children from 1 to 6 years old - 0.75 ml;
  • children under 10 years old - 1.5 ml;
  • children over 10 years old and adults - 3 ml.

It is allowed to administer immunoglobulin again if it is necessary to prevent hepatitis A not earlier than 2 months after the first injection.

For the prevention of measles, human immunoglobulin is administered once to children from the age of three months and to adults who have not had measles and are not vaccinated against this infection. The injection is made no later than 6 days after contact with the patient. The dose of the drug for children (1.5 or 3 ml) is set individually, depending on the time elapsed from the moment of contact and the state of health. If adults or children have been in contact with mixed infections, they are injected with 3 ml of the drug.

For the prevention and treatment of mild forms of influenza, a single injection of human immunoglobulin is sufficient. Children under 2 years of age are administered 1.5 ml of the drug, from 2 to 7 years - 3 ml, over 7 years and adults - 4.5-6 ml. Patients with a severe form of influenza after 24-48 hours are re-introduced the same dose of immunoglobulin. For children who have not had whooping cough and are not vaccinated or not fully vaccinated, the drug is administered twice with an interval of 24 hours in a single dose of 3 ml. The injection should be performed as soon as possible after contact with the patient, but no later than 3 days.

Children aged 6 months to 7 years who have contact with a patient with a generalized form of meningococcal infection are injected intramuscularly with 1.5 ml or 3 ml of the drug. For the prevention of poliomyelitis in unvaccinated or inadequately vaccinated children with polio vaccine once in 3-6 ml of human immunoglobulin as early as possible after contact with the patient.

Doctors at the Yusupov Hospital use human immunoglobulin to treat hypogammaglobulinemia or agammaglobulinemia at a dose of 1 ml per 1 kg of body weight. The calculated dose of the drug is administered in 2-3 doses with an interval of 24 hours. Subsequent injections of immunoglobulin, if indicated, are carried out no earlier than after 1 month. During the period of convalescence (recovery) of acute infectious diseases with a protracted course and chronic pneumonia, the drug is administered to increase the body's resistance. For 1 kg of body weight, 0.15-0.2 ml of immunoglobulin must be administered. The frequency of administration (up to four injections) is determined by the immunologist of the Yusupov hospital. The intervals between injections are 2-3 days.

When human immunoglobulin is administered, there are usually no side effects. Sometimes, during the first days after the administration of the drug, the body temperature may rise to 37.5 °C, or reddening of the skin may appear at the injection site. Patients with altered reactivity occasionally develop allergic reactions of various types, and extremely rarely - anaphylactic shock. In this regard, patients after the introduction of a simple immunoglobulin are under the supervision of a doctor at the Yusupov hospital for 30 minutes. The manipulation room is provided with anti-shock therapy.

Call the clinic's phone number and make an appointment with an immunologist. The doctor will determine the indications and contraindications for the use of human immunoglobulin, draw up an individual scheme for prevention or treatment.

Bibliography

  • ICD-10 (International Classification of Diseases)
  • Yusupov hospital
  • "Diagnostics". - Brief Medical Encyclopedia. - M.: Soviet Encyclopedia, 1989.
  • "Clinical evaluation of the results of laboratory studies" / / G. I. Nazarenko, A. A. Kishkun. Moscow, 2005
  • Clinical laboratory analytics. Fundamentals of clinical laboratory analysis V.V. Menshikov, 2002.

Prices for diagnostic studies

*The information on the site is for informational purposes only. All materials and prices posted on the site are not a public offer, determined by the provisions of Art. 437 of the Civil Code of the Russian Federation. For exact information, please contact the clinic staff or visit our clinic. The list of paid services provided is indicated in the price list of the Yusupov hospital.

*The information on the site is for informational purposes only. All materials and prices posted on the site are not a public offer, determined by the provisions of Art. 437 of the Civil Code of the Russian Federation. For exact information, please contact the clinic staff or visit our clinic.

Immunoglobulins are the very antibodies that are one of the main factors of immunity. Protective processes constantly occurring in our body are extremely complex. Immunoglobulins are involved in the implementation of the functions of humoral immunity - that is, the protection that acts in biological fluids: tissue fluid, lymph, blood serum.

Antibodies - provide specific immunity, that is, protection against specific pathogens, foreign tissues, toxins, and so on - antigens. For example, when an organism encounters a virus herpes, antibodies are produced in his blood specifically to this type of herpes virus (and not to all its types or not to all viruses in general).

Mechanisms of action of immunoglobulins

Greatly simplifying the intricate paths of biochemical transformations, we can say that first function antibodies - stick to the surface of the antigen. Thus, other cells responsible for the destruction of viruses, bacteria, fungi, and other factors that can destroy our health receive a signal where their goal is - move towards it and begin to dissolve it, absorb it, remove it from the body.

Second function - start other reaction mechanisms: inflammation, allergies, and so on.

Types of antigens and immunoglobulins

  • They act against pathogens anti-infectious antibodies.
  • Act against toxins released by pathogens antitoxic antibodies.
  • Against tissues of representatives of the same biological species (tissues of another person, for example, during transplantation) allo antibodies .
  • Act against tissues of representatives of another biological species isoantibodies .
  • Excess antibodies are destroyed anti-idiotypic antibodies.
  • The development of autoimmune diseases, when the tissues of the body itself are destroyed, is associated with the formation autoantibodies , "fighting" with their own tissues.
  • Finally, there are witness antibodies , which appear when the body encounters an infection, but does not affect its development in any way.

Classification of immunoglobulins

IgA - immunoglobulins, which carry out the primary protection of the body, being in saliva, tears, on the mucous membrane of the respiratory tract, genital organs.

IgD - obviously, they participate in the "specialization" of lymphocytes, "targeting" them to different antigens.

IgM - the earliest antibodies that arise when the body first encounters an antigen. When immunoglobulins of this class are detected, for example, to the varicella-zoster virus, it can be said that a person has recently encountered this infection for the first time.

Immunoglobulin IgG

The main immunoglobulin in human blood - both in terms of versatility and in terms of the amount in serum. These are antibodies responsible for long-term immunity. This is the only immunoglobulin that is transmitted from mother to child, penetrating the placental barrier, and allows you to form passive immunity in the first months of the baby's life, while he develops his own antibodies.

This immunoglobulin is obtained from the blood of healthy donors and administered as a drug, for example, in severe infectious diseases or as a substitute for own antibodies in immunodeficiency. Treatment with human normal immunoglobulin is a complex process that can only take place under the supervision of doctors.

Immunoglobulins IgE

These antibodies are also found on the mucous membranes and activate the body's defenses if the "defense line" of IgA antibodies is "broken". These immunoglobulins trigger the mechanisms of inflammation, allergies, "calling" to the place of "invasion" all other cells and IgG antibodies. These antibodies are negligible in the serum, but with the development of allergic diseases, for example, bronchial asthma or urticaria, they are found in large quantities.

Diagnosis of diseases using the determination of immunoglobulins

Medicine has not only studied the functions of antibodies in the body, but has also developed analysis methods that can clarify the picture of the presence of certain immunoglobulins in a particular patient (see immunogram). This allows you to diagnose the disease without detecting the pathogen itself, but only antibodies to it.

For example, if IgM predominates (antibodies of this class against a specific pathogen), it means that the infection has entered the body recently. If there are no specific IgM, but there are IgG to this pathogen, then this “meeting” took place a long time ago (either a complete cure or the transition of the infection to a chronic form is possible). IgE, as we have already said, are present in the active allergic process. And so on.

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Treatment of severe forms of bacterial and viral infections. Treatment of postoperative complications accompanied by bacteremia and septicopyemic conditions. Primary antibody deficiency syndrome - agamma- and hypogammaglobulinemia (congenital form, period of physiological deficiency in newborns). Secondary antibody deficiency syndrome. Blood diseases, consequences of immunosuppressive therapy, acquired immunodeficiency syndrome (AIDS), especially when children are infected with the human immunodeficiency virus.

Contraindications Human immunoglobulin normal solution for intravenous injection 50mg/ml 25ml

History of allergic reactions or severe systemic reactions to human blood products. In cases of severe sepsis, the only contraindication is a history of anaphylactic shock to human blood products. IgA immunodeficiency.

Method of administration and dosage Human immunoglobulin normal solution for intravenous injections 50mg/ml 25ml

Immunoglobulin for infusions is used only in a hospital setting. Before administration, the vials are kept at a temperature of (20±2)°C for at least 2 hours. Turbid and sediment-containing solutions should not be used. The dose and frequency of administration of the drug depend on the indications for use. For children, a single dose of the drug is 3-4 ml per 1 kg of weight, but not more than 25 ml. The rate of infusion and the duration of therapy is selected by the doctor individually. Immediately before administration, the drug is diluted with 0.9% sodium chloride solution or 5% glucose solution at the rate of 1 part of the drug and 4 parts of the diluent. Diluted immunoglobulin is injected intravenously at a rate of 8-10 drops per minute. Infusions are carried out daily for 3-5 days. For adults, a single dose of the drug is 25-50 ml. Immunoglobulin (without additional dilution) is administered intravenously at a rate of 30-40 drops per minute. The course of treatment consists of 3-10 transfusions carried out after 24-72 hours (depending on the severity of the disease).

Human normal is a drug that is made from donated blood (its plasma). Immunoglobulin itself is a protein that is responsible for the body's immune response to the penetration of foreign factors (bacteria, viruses, fungi, and so on). Simply put, these are antibodies - the main link of specific protection, distributed in human blood. In its properties, human normal immunoglobulin is practically identical to immunoglobulin type G (IgG), which determines long-term humoral (that is, carried out in body fluids) immunity. Also, this drug has a non-specific effect, showing anti-inflammatory and restorative activity.

Indications for the introduction of human normal immunoglobulin are a variety of conditions associated with the suppression of the body's own defense systems. Firstly, this remedy can be used in replacement therapy, that is, to replace absent or extremely weakened immunity in immunodeficiencies. Such pathologies include HIV, congenital or acquired agammaglobulinemia, condition after bone marrow transplantation, and so on. Secondly, the positive effect of Human Normal Immunoglobulin is observed in: various infectious and inflammatory acute and chronic diseases, immunosuppression due to prolonged use of a certain drug, autoimmune diseases, and many, many others.

Normal human immunoglobulin is produced for intramuscular and intravenous administration - and the first type of the drug should never be injected into a vein. The instruction of the drug describes the basic principles by which the treatment is carried out. For example, an intravenous form of Immunoglobulin should be administered slowly through a dropper, diluting it in saline. The concentration of the solution of this drug can be from 3 to 12 percent - but never higher! In general, the main thing that should be understood from this annotation: Normal human immunoglobulin is never used on its own - without the exact instructions of a doctor.

Contraindications for use, side effects and overdose of Human Normal Immunoglobulin

Do not administer this drug to patients with intolerance to blood products, as well as if he has antibodies to immunoglobulin A (IgA) in his blood. Carefully, only after consultation with the relevant specialists, Immunoglobulin is prescribed for dysfunctions of the heart, kidneys, diabetes mellitus, migraines, acute allergic process, during childbearing and feeding.

This drug has an extensive systemic effect. Usually, subject to all the rules of injections and infusions, it is normally tolerated by the patient's body. But complications can affect the work of all systems - digestive, nervous, cardiovascular. The most dangerous and rare phenomenon is necrosis (necrosis) of the renal tubules. It is worth remembering that any administration of Immunoglobulin can cause anaphylactic shock or other allergic reactions, even if previous injections have gone without complications.

With an overdose, the likelihood of side effects increases, blood viscosity and volume increase.

Immunoglobulin during pregnancy

Human normal immunoglobulin can be administered to a pregnant woman with a threat of miscarriage or premature birth, as well as against the background of other conditions, for example, infections that threaten the health and life of the mother or fetus. The question of such an appointment is decided individually, by specialists, based on a lot of data.

Human immunoglobulin (normal human immunoglobulin) is an immunological drug that replenishes the missing IgG class antibodies, reducing the risk of developing infectious diseases in patients with immunodeficiency (both primary and secondary).

Release form and composition

Dosage forms of Human Immunoglobulin:

  • Solution for intramuscular injection, in ampoules of 1, 1.5 and 3 ml;
  • Solution for intravenous administration, in bottles for blood substitutes with a volume of 25 and 50 ml.

The active substance of the drug is human normal immunoglobulin, which is an immunoglobulin fraction isolated from human plasma, then purified and concentrated. In 1 ml of solution for intravenous infusion, its concentration is 50 mg, in 1 dose of solution for intramuscular injection - 1 ml, 1.5 ml or 3 ml.

Indications for use

Intramuscularly, human immunoglobulin is prescribed to increase the body's nonspecific resistance during immunosuppressive therapy, during convalescence, and also in debilitated patients.

In addition, the / m drug is used for emergency prophylaxis:

  • meningococcal infection;
  • whooping cough;
  • Poliomyelitis.
  • Corey;
  • Hepatitis A;
  • Rubella in the first trimester of pregnancy in non-immune patients and in women with unknown immune status.

Intravenous administration of Immunoglobulin is indicated for:

  • blood diseases;
  • Kawasaki disease;
  • The consequences of immunosuppressive therapy;
  • Chronic lymphocytic leukemia;
  • Guillain-Barré syndrome;
  • Idiopathic thrombocytopenic purpura;
  • multiple sclerosis;
  • Primary immunodeficiency;
  • Syndrome of hyperimmunoglobulinemia E;
  • Eaton-Lambert syndrome;
  • Dermatomyositis;
  • Acquired immunodeficiency syndrome (HIV infection);
  • Agamma- and hypogammaglobulinemia (primary antibody deficiency syndrome), including congenital form and physiological deficiency in newborns;
  • Secondary antibody deficiency syndrome;
  • Infections caused by parvovirus B19;
  • Chronic inflammatory demyelination in polyneuropathy;
  • Dermatomyositis;
  • Severe forms of viral and bacterial-toxic infections, including postoperative complications accompanied by sepsis or bacteremia.

As part of complex treatment, human immunoglobulin is prescribed for long-term diseases that are difficult to respond to antibiotic therapy.

For the prevention of infections, the drug can be used during bone marrow transplantation, as well as in newborns, children with low birth weight and premature babies.

Contraindications

Immunoglobulin is contraindicated in:

  • Hypersensitivity to human immunoglobulins;
  • Allergic and / or severe systemic reactions to human blood products in history;
  • exacerbation of allergies;
  • IgA immunodeficiency.

With caution, the drug is used in diabetes mellitus, renal and severe heart failure, during lactation and pregnancy.

In cases of severe sepsis, the only contraindication to human immunoglobulin is a history of anaphylactic shock due to the administration of blood products.

Method of application and dosage

The drug is used only in a hospital setting.

  • Intramuscular use of human immunoglobulin.

For the prevention of measles, no later than 4 days after contact with a sick person: for children from 3 months old who have not had measles and are not vaccinated, 1.5 or 3 ml is administered once, adults - once 3 ml.

For the prevention of poliomyelitis in unvaccinated or not fully vaccinated children, 3-6 ml is prescribed once as soon as possible after contact with a patient with a paralytic form of the disease.

For the prevention of hepatitis A, children over 10 years old and adults are administered 3 ml, children 7-10 years old - 1.5 ml, children 1-6 years old - 0.75 ml once. If necessary, re-introduction is possible, but not earlier than after 2 months.

For the prevention and treatment of influenza, a single administration of Immunoglobulin is indicated: for children over 7 years old and adults - 4.5-6 ml, for children 2-7 years old - 3 ml, for children under 2 years old - 1.5 ml. In severe forms of influenza, a second injection is made after 24-48 hours.

For the prevention of whooping cough in healthy children, a double injection of 3 ml with an interval of 24 hours is shown.

For the prevention of meningococcal infection, no later than 7 days after contact with a patient with a generalized form of infection, children from 6 months to 3 years old are administered 1 ml, children from 4 years old - 3 ml.

  • Intravenous use of human immunoglobulin.

A single dose for adults is 25-50 ml. For children, the dosage is calculated based on weight - 3-4 ml / kg, but not more than 25 ml.

The vials are kept at room temperature for at least 2 hours. Immediately before administration, Immunoglobulin is diluted with 5% glucose solution or 0.9% NaCl solution in a ratio of 1:4.

The diluted drug is administered intravenously at a rate of 8-10 drops/minute. The course of treatment is 3-10 infusions at intervals of 1-3 days. It is possible to use the solution in its pure form, but in this case it is administered at a rate of not more than 40 drops / min.

Children are allowed only intravenous drip infusions. The duration of treatment is 3-5 days.

Specific doses, frequency of administration and duration of treatment are determined by the doctor individually for each patient, taking into account indications.

Side effects

In general, the drug is well tolerated; on the first day, a slight increase in body temperature (up to 37.5 ºC) is possible.

In some cases (no more than 1 patient out of 100) are noted:

  • Dizziness and headache, incl. migraine;
  • Abdominal pain, nausea and/or vomiting, diarrhea;
  • Fluctuations in blood pressure, tachycardia and cyanosis;
  • shortness of breath, tightness or chest pain;
  • Hyperemia at the injection site.

In individual cases, the following are possible: back pain, fever or a feeling of cold, malaise, increased sweating, a pronounced decrease in blood pressure, chills, myalgia, acute necrosis of the renal tubules, aseptic meningitis, allergic reactions, up to anaphylactic shock.

Too rapid intravenous administration of the drug is fraught with the development of a collaptoid reaction.

special instructions

For at least 30 minutes after the IV infusion, the patient should be under the supervision of a physician. Anti-shock therapy must be provided in the room.

Human immunoglobulin solution for intramuscular injection is strictly forbidden to be administered intravenously.

A temporary increase in antibodies in the blood after injection leads to false-positive serological results.

Immunoglobulin can weaken the effect of live vaccines against rubella, measles, chicken pox and mumps. For this reason, vaccinations against these diseases are given no earlier than 3 months after Ig treatment.

In some cases, after the introduction of large doses of the drug, its effect can last up to a year.

Infants should not be given Human Immunoglobulin in combination with calcium gluconate.

Analogues

  • Synonyms: Gamimun N, Gabriglobin, Gabriglobin-IgG, I.G. Vienna N.I.V., Gamunex, Intraglobin, Immunovenin, Intratekt, Imbioglobulin, Octagam, Phlebogamma 5%, Privigen;
  • Analogs: Immunoglobulin complex preparation, Histaseroglobulin, Pentaglobin and Immunoglobulin enriched with human IgM.

Terms and conditions of storage

Store Human Immunoglobulin at a temperature of 2-8 ºC. Do not freeze! Shelf life - 1 year.

Immunoglobulin human normal (Immunoglobulin human normal)
Por.liof.d/inf. 500mg/10ml; 1 g/20ml; 2.5 g/50 ml; 5 g/100 ml
Pore.lyof.d / solution in / in 2.5 g; 5 g

Mechanism of action

Human immunoglobulin contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. Replenishes missing IgG antibodies, reduces the risk of infections in patients with primary and secondary immunodeficiency. In high doses, when administered intravenously, it has an immunomodulatory effect.

Pharmacokinetics

After i / m administration, the maximum content of antibodies in the blood occurs after 24-48 hours and lasts up to 14 days. Penetrates through the placenta. T1 / 2 - 4-6 weeks.

With intravenous infusion, bioavailability is 100%. It is redistributed between plasma and extravascular space, equilibrium is reached after approximately 7 days. In individuals with a normal IgG content in the blood serum, the biological half-life is on average 21 days, while in patients with primary hypo- or agammaglobulinemia - 32 days.

Indications

For intramuscular injection
■ Emergency prevention of measles, hepatitis A, whooping cough, poliomyelitis, meningococcal infection, increase in nonspecific resistance of the organism.

For intravenous administration
■ Inflammatory myositis
■ Kawasaki disease.
■ Primary immunodeficiency.
■ Idiopathic thrombocytopenic purpura, chronic lymphocytic leukemia.
■ HIV infection.
■ Severe forms of bacterial-toxic and viral infections (including postoperative complications accompanied by sepsis).
■ Guillain-Barré syndrome, multiple sclerosis, chronic inflammatory demilienization in polyneuropathy.
■ Syndrome of hyperimmunoglobulinemia E.
■ Eaton-Lambert syndrome.
■ Infections caused by parvovirus B19.
■ Prevention and treatment of infections in newborn premature babies, babies with low birth weight.

Contraindications

■ Hypersensitivity (including to maltose and sucrose).
■ IgA immunodeficiency.

Cautions

For the manufacture of human normal immunoglobulin, plasma of healthy donors is used, in which antibodies to HIV type 1 and 2, hepatitis C virus (HCV) were not detected, and the surface antigen of hepatitis B virus (HbsAg), transamine activity does not exceed the normal value.

Immunoglobulins for intramuscular administration, it is strictly forbidden to administer intravenously.

During treatment, you should:
■ after the introduction of drugs to observe the patient's condition for at least 30 minutes;
■ be aware that immunoglobulin passes into breast milk and may contribute to the transfer of protective antibodies to the newborn;
■ remember that when conducting serological studies (Coombs reaction), it is possible to obtain false positive data due to a temporary increase in antibodies in the blood;
■ persons suffering from systemic diseases (diseases of the blood, connective tissue, glomerulonephritis, etc.), and diseases of the immune system, immunoglobulins should be administered against the background of appropriate therapy and control of the function of the relevant systems;
■ do not exceed the rate of intravenous injection due to the possibility of developing collaptoid reactions;
■ when administered in the first 2 weeks after vaccination against measles, mumps and rubella, vaccinations with these vaccines should be repeated no earlier than 3 months later;
■ take into account that after the introduction of large doses of immunoglobulin, its effect may last in some cases up to one year;
■ Do not use simultaneously with calcium gluconate in infants.

Prescribe with caution:
■ in severe heart failure;
■ with diabetes;
■ with renal failure;
■ during pregnancy (according to strict indications, when the intended benefit to the mother outweighs the potential risk to the fetus);
■ when breastfeeding.

Interactions

Side effects

■ Gastrointestinal tract - nausea, vomiting, abdominal pain, diarrhea.
■ CNS - headache, dizziness, migraine pain; rarely - loss of consciousness, fatigue, malaise, numbness, aseptic meningitis.
■ Cardiovascular system - a feeling of pressure or pain in the chest, arterial hypo- or hypertension, tachycardia, cyanosis.
■ Urinary system - acute necrosis of the renal tubules (rare).
■ Other reactions - chills, shortness of breath, allergic reactions; rarely - a pronounced decrease in blood pressure, collapse, loss of consciousness, hyperthermia, chills, increased sweating, back pain, myalgia, fever or a feeling of cold.
■ Local reactions - hyperemia of the skin at the injection site (rarely).

Dosage and administration

In / in 25-50 ml 1 r / day.
An undiluted drug is administered intravenously by drip, at a rate of up to 40 drops / min.
The course of treatment consists of 3-10 infusions performed every 1-3 days.

Synonyms

Biaven V.I., Normal human immunoglobulin, Normal human immunoglobulin for intravenous administration, Normal human immunoglobulin for intravenous administration, Vigam-S, Vigam-liquid, Humaglobin, Intraglobin, Octagam, Sandoglobulin, Immunovenin, Gabriglobin (Human normal immunoglobulin for intravenous administration dry), I.G. Vena N.I.V., Imbiogam.

Normal human immunoglobulin- This is a medicinal and prophylactic drug that belongs to the group of immunostimulating and immunomodulating agents. It is produced from the blood of healthy donors who have undergone special clinical examinations and laboratory tests and do not have signs of blood-borne infections (in particular, HIV infections, hepatitis C and B).

The main component of this drug is an immunologically active blood protein fraction, which is mainly represented by immunoglobulin G and contains immunoglobulin M and immunoglobulin A in small concentrations. The drug is subjected to thorough purification, concentration and viral inactivation during manufacture. Normal human immunoglobulin does not contain preservatives and antibiotics; it contains glycine as a stabilizer.

Form of release and method of application of normal human immunoglobulin

The drug can be produced in the form of a solution packaged in ampoules, or in the form of a lyophilisate for the manufacture of a solution packaged in bottles. In liquid form, it is colorless or yellowish, transparent. The lyophilisate of normal human immunoglobulin is a porous hygroscopic white mass. Normal human immunoglobulin is used for intramuscular (injections) and intravenous (droppers) administration.

Properties of normal human immunoglobulin

The drug has the properties of immunoglobulin G, which is present in healthy people. With its introduction, the following effects are achieved:

  • replenishment of the missing IgG antibodies, which helps to reduce the risk of developing various infections;
  • resumption of low IgG levels to normal values;
  • increase in nonspecific resistance of the human body;
  • suppression and neutralization of a wide range of bacteria, viruses and other infectious agents.

Indications for the use of normal human immunoglobulin:

  • congenital antibody deficiency syndrome;
  • common variable immunodeficiency;
  • iatrogenic immunodeficiency;
  • chronic lymphocytic leukemia;
  • myeloma;
  • thrombocytopenic purpura of immune origin with an increased risk of bleeding;
  • Kawasaki disease;
  • bone marrow transplant;
  • severe infections of various origins;
  • bacterial meningitis;
  • Guillain-Barré syndrome;
  • demyelinating polyneuropathy of an inflammatory nature in a chronic form;
  • hemolytic anemia;
  • thrombocytopenia of immune origin;
  • autoimmune neutropenia;
  • partial red cell aplasia of hematopoiesis;
  • recurrent spontaneous miscarriage;
  • hepatitis A;
  • measles;
  • polio;
  • flu;
  • whooping cough;
  • meningococcal infections, etc.

Immunoglobulin Therapy (Intravenous Immunoglobulin)

Description

Immunoglobulins are special blood proteins that help the body fight infections. Immunoglobulins produce white blood cells (leukocytes), also known as antibodies. Antibodies are essential to the immune system. In immunoglobulin therapy (IVIG), additional donor immunoglobulins are injected into the patient's blood.

Reasons for Intravenous Immunoglobulin

Immunoglobulin is used to treat diseases and disorders of the immune system, such as:

  • Autoimmune diseases, when the body begins to attack its own cells;
  • Immunodeficiency - low functionality of the immune system;
  • Inflammatory diseases;
  • Other diseases that weaken the immune system.

An injection of immunoglobulin can also reduce inflammation in the body. Some diseases, including acute infections, require the administration of immunoglobulin to restore antibodies and strengthen the immune system.

Possible complications of intravenous immunoglobulin administration

Complications are rare, but no procedure is guaranteed to be risk-free. Before performing IVIG, you need to be aware of possible complications, which may include:

  • Headache;
  • Infection;
  • Fluid in the lungs;
  • kidney damage;
  • blood clots;
  • Allergic reaction to IVIG.

How is intravenous immunoglobulin administered?

Preparation for the procedure

No special preparation is required before the procedure. Before the injection is carried out, a survey is carried out for the presence of viruses, diseases and infections.

Description of IVIG procedure

Concentrated immunoglobulin antibodies will be selected from a healthy person. These antibodies are added with a sterile solution.

A needle is inserted into a vein in the arm. The solution is injected into a vein through a dropper.

How long will intravenous immunoglobulin take?

About 5-6 hours.

Intravenous immunoglobulin - will it hurt?

This procedure is not painful. There may be some when the needle is inserted into the skin.

Care procedures after IVIG

There may be irritation at the site where the needle was inserted. If this happens, you should consult your doctor.

You may see an improvement in the symptoms of the disease 24-48 hours after the procedure. In some patients, improvement occurs only after 3-4 weeks.

Immunoglobulin therapy is usually carried out in several cycles. For infections or other signs of immunodeficiency, immunoglobulin administration is usually recommended every 3-4 weeks. If you have a neurological or autoimmune disease, treatment is carried out five days a month for 3-6 months. After initial therapy, maintenance therapy is given every 3-4 weeks.

Communication with the doctor after intravenous administration of immunoglobulin

With the introduction of any foreign or chemical substance into the body, there is the possibility of an allergic reaction. If you experience any of the following symptoms of anaphylactic shock (severe allergic reaction), call your doctor immediately:

  • shortness of breath and/or difficulty breathing;
  • Confusion;
  • slurred or abnormal speech;
  • fast and palpitations, weakness or rapid heart rate;
  • Blue tint to skin, lips, or nails;
  • dizziness, weakness;
  • hives, rash or itching;
  • Anxiety;
  • Nausea, vomiting, diarrhea, abdominal cramps;
  • cough or nasal congestion;
  • Redness of the skin.