Human immunoglobulin. What threatens the uncontrolled use of immunomodulators. Method of application and dosage

Basically, people try to make an appointment with an immunologist who prescribes immunomodulators for them. According to doctors and pharmacists, this is the best way to improve the body's defense against diseases, especially in the autumn-winter period and the growth of SARS epidemics.

But is the action of immunomodulators as effective as they are trying to present it to us?

Debunking the Myths

Myth 1. Medicines, called immunomodulators, are divided into three groups according to the type of origin: exogenous, endogenous and chemical. Each of them is aimed at strengthening the protective properties of various organs. In fact, in order to help your body protect against pathological bacteria and viruses, you need to understand which area of ​​your body is susceptible to attack and whether it is worth spending money and time on immune stimulants.

Myth 2. In the cold season, many people are prone to colds. According to them, this is due to the deterioration of the immune system. And here they are deeply mistaken. Constantly blaming your defensive functions is stupid. To strengthen the immune system, it is worth eating properly and balanced, walking more often in the fresh air and going out into nature, normalizing sleep and relaxing during the day, tempering, leading an active lifestyle, and avoiding stressful situations. Then your immune system will have more strength to fight pathological microorganisms.

Myth 3. During the period of exacerbation of infectious diseases, it is necessary to get vaccinated to increase immunity. Unfortunately, its effectiveness will be less than that of a vaccine aimed at preventing a specific disease.

Myth 4. Many people believe that immunostimulants are devoid of side effects. Do not forget that with a large long-term use of such drugs, the body's immune system loses the ability to produce antigens. As a result, the body cannot independently resist diseases, hoping for the next portion of stimulants. Do not abuse even those drugs that seem to be aimed at improving the protective properties of the body.

Myth 5. Plant-based immunomodulators are harmless. Absolute delusion. After all, there are plants that can cause an allergic reaction in people, and in case of an overdose, other side effects.

Myth 6. There are two types of immunomodulating drugs for adults and children: immunostimulants, aimed at increasing immunity, and immunosuppressants, aimed at lowering immunity. Some may think that artificially lowering immunity is fraught with negative consequences.

Hyperactivity of the immune system, along with immunodeficiency, is dangerous for the human body. To take such drugs, you first need to consult an immunologist, otherwise you can greatly harm your health.

Myth 7. Prevention of colds can be effective only in the form of taking immunomodulators. Not at all. The best prevention against all diseases of the body is considered to be a proper balanced diet, walks in the fresh air and physical activity alternately with proper rest and sleep. No pills and potions will replace this.

What threatens the uncontrolled use of immunomodulators

The effectiveness of immunomodulators, as well as other medicines, does not increase with an independent excess of the dosage prescribed by the doctor or the duration of use. On the contrary, violating medical recommendations and the scheme of taking immunomodulatory drugs, one can provoke hyperactivity of the body's immune system - a condition in which, having eliminated foreign agents, protection does not stop and the function of recognizing "us" and "them" is impaired. The most common consequence of this is an acquired allergy to certain foods and drugs.

But there is a more severe version of the consequences of an overactive immune system: the joints, heart, skin are affected, and an infectious-toxic shock can also occur, leading to death.

Also, due to the uncontrolled use of immunomodulators, the anti-inflammatory system can fail when the body stops resisting infections and becomes defenseless against the attack of bacteria, microbes and viruses. Active reproduction of conditionally safe microorganisms that inhabit the human microflora (for example, yeast fungi of the genus Candida) may begin.

However, homeopathic immunomodulators, the use of which is longer due to the slow effect on the body (when compared with synthetic analogues), restore the immune system without having a pathological effect on its functions.

Natural protection - natural immunomodulators

Our distant ancestors stimulated their immunity by eating medicinal plants. These include anti-cold and tonic remedies known since childhood to every person: onion and garlic, pollen, propolis, honey, rosehip, ginseng, echinacea, lemongrass, cranberry, mummy and herbal preparations. By systematically adding at least some of these products to food or drinking infusions, you will be much less likely to be exposed to any ailments, and you will also significantly save your money.

Lead the right lifestyle, take care of your health, and then you will not need the help of doctors!

medbooking.com

Immunoglobulin

If, when using the drug, all recommendations for administration, dosage and precautions are observed, then the presence of serious side effects is very rare. Symptoms may appear hours or even days after administration. Almost always, the side effects disappear after you stop taking Immunoglobulin. The main part of the side effects is associated with a high rate of infusion of the drug. By reducing the speed and temporarily suspending reception, you can achieve the disappearance of the bulk of the effects. In other cases, it is necessary to carry out symptomatic therapy.

The manifestation of effects is most likely at the first dose of the drug: during the first hour. It can be a flu-like syndrome - malaise, chills, high body temperature, weakness, headache.

The following symptoms also occur: - respiratory system (dry cough and shortness of breath); - digestive system (nausea, diarrhea, vomiting, stomach pain and increased salivation); cardiovascular system (cyanosis, tachycardia, chest pain, flushed face);

Central nervous system (drowsiness, weakness, rarely symptoms of aseptic meningitis - nausea, vomiting, headache, photosensitivity, impaired consciousness, stiff neck);

Kidneys (rarely acute tubular necrosis, exacerbation of renal failure in patients with impaired renal function).

Allergic (itching, bronchospasm, skin rash) and local (hyperemia at the site of intramuscular injection) reactions are also possible. Other side effects include myalgia, joint pain, back pain, hiccups, and sweating.

In very rare cases, collapse, loss of consciousness and severe hypertension have been observed. In these severe cases, drug withdrawal is necessary. It is also possible to administer antihistamines, epinephrine and solutions that replace plasma.

medhall.com

Is there any harm from anti-rhesus immunoglobulin -?

As much as possible all my life I try to avoid unnecessary vaccinations, but I don’t know what to do now. According to the testimony, I need to go to the TsPSiR the other day - to inject immunoglobulin (I am 32 weeks old, they inject until the 34th). I read here the description-tips from donnafugata (thank you!) - it became clear what you need for the trip (everything is there). I understand the need for a drug. But I want to understand the possibility of harm - is it there ??? Or is it ABSOLUTELY safe (for a woman, for a child?)

1) There is more harm from a domestic drug. But he is usually injected only after childbirth, within 72 hours. 2) The degree of harm of the imported drug is not yet clear, the side effects are the same for all three imported vaccines:

HyperRow SD HyperRHO S/D - USA http://www.women-medcenter.ru/index.phtml?id=591

Side effects of antirhesus immunoglobulin Hyper Row Possible: hyperemia, fever up to 37.5 ° C (during the first day after administration), dyspepsia. In some cases: patients with altered reactivity (including immunoglobulin A deficiency) may develop various types of allergic reactions (including anaphylactic shock). Rh-negative puerperas, sensitized to the Rh0(D) antigen (in whose blood serum Rh antibodies are found). - Hypersensitivity to the drug. - It is forbidden to administer the drug to newborns.

BayRoady - Bayer Corporation, USA

Side effects and contraindications are the same. More added:

Individual patients with altered reactivity may develop various types of allergic reactions, including anaphylactic shock, and therefore patients who have received the drug should be monitored for 30 minutes after drug administration.

For prophylaxis in the prenatal period, one dose of the drug (300 mcg) should be administered approximately at the 28th week of pregnancy. This should be followed by another dose (300 mcg), preferably within 72 hours after delivery, if the baby is born Rh-positive.

RhopHylac 300 - Germany

In Russia, it is not certified and is not for sale. As a result, I injected myself with HyperRow. Everything, thank God, is in order. Tags: blood type/rhesus

en-perinatal.livejournal.com

Immunoglobulin - instructions for use, reviews

Immunoglobulin is an immunostimulatory drug.

Release form

The drug is available as a solution for intramuscular and intravenous administration, as well as in the form of a powder for injection.

pharmachologic effect

Immunoglobulin is a globular protein that is produced by special cells in the human body. Globular protein takes an active part in the formation of the immune response.

There are various types of proteins, among which are immunoglobulin G, immunoglobulin E, human immunoglobulin, anti-rhesus immunoglobulin, immunoglobulins M and A. All these proteins differ in amino acid composition, structure and functions.

Immunoglobulin G accounts for about 70% of all serum proteins. Its most important functions include the ability to penetrate the placental barrier in order to provide the body of the newborn with natural passive immunity. Immunoglobulin G is involved in the development of the immune response, is involved in complement activation, and enhances phagocytosis. The production of this type of protein requires the obligatory presence of T-lymphocytes. Reception of immunosuppressants and radiation contribute to the suppression of immunoglobulins G.

The share of Immunoglobulin M accounts for 5-10% of the total amount of proteins. This type of protein is the first to be synthesized in the newborn organism. Immunoglobulin M is an early antibody that fights viruses and Gram-negative bacteria. The protein is involved in complement activation, enhances phagocytosis. This group of proteins includes antibodies against streptococcus, cold agglutinins, blood group agglutinins, and rheumatoid factor. They help attract phagocytes to the site of infection, activate phagocytosis. Immunoglobulins M are weakly specific - they can simultaneously bind up to 5 antigen molecules. Thus, large immune complexes are formed, which leads to the rapid removal of antigens from the circulation and does not allow them to attach to cells.

The norm of immunoglobulin in children should be: at 1-3 months of a baby's life - 0-2 kU / l, at 3-6 months - 3-10 kU / l, at 1 year - 8-20 kU / l, at 5 years - 10-50 kU / l, at 15 years old - 16-60 kU / l. For adults, the norm is 20-100 kU / l.

The share of immunoglobulin A accounts for 10-15% of the total. It is found in tears, saliva, gastric secretions, intestinal secretions, lungs, vagina, urinary tract, bronchi. A large amount of protein is found in breast milk, thanks to which, with natural feeding, the baby is protected from the very first days. This type of protein helps to neutralize bacterial toxins and viruses, and also provides protection to the mucous membranes.

Human immunoglobulin is characterized by a high content of antibodies that fight against various pathogens. It helps to reduce the likelihood of infections in patients with immunodeficiency and replenish the lack of G-antibodies.

Anti-Rhesus immunoglobulin is injected into a woman's body during pregnancy when a Rh conflict is detected to prevent Rh sensitization. The protein contributes to the destruction of fetal RBCs with a positive Rh in the mother's bloodstream, preventing the production of anti-Rh maternal antibodies.

Indications

Immunoglobulin G is prescribed for liver cirrhosis, infectious diseases, viral and chronic autoimmune hepatitis, dermatomyositis, multiple myeloma, systemic lupus erythematosus, AIDS, rheumatoid arthritis, HIV infections, sepsis, meningitis, sinusitis, oncopathologies, otitis, pneumonia.

Immunoglobulin E is effective in such allergic diseases as food and drug allergies, hay fever, atopic dermatitis, eczema, bronchial asthma, and helminthiases. The drug is also used to evaluate the development of allergies in children.

Human immunoglobulin should be taken for congenital hypogammaglobulinemia, agammaglobulinemia, severe combined immunodeficiencies, deficiency of immunoglobulin G subclasses, for replacement therapy in myeloma, AIDS in children, chronic lymphocytic leukemia.

Rh immunoglobulin is prescribed to women who have a negative Rh, in which Rh antibodies are not produced. It is also taken if it is required to terminate a pregnancy artificially in women who are Rh negative.

Instructions for use (method and dosage)

The drug is administered intravenously or intramuscularly. The route of administration of the drug is determined by the doctor. The norm of immunoglobulin is set by a specialist individually in each case, depending on the diagnosis.

Side effects

When taking certain norms of immunoglobulin in each individual case, side effects occur extremely rarely. As a rule, after the end of the course, they disappear almost immediately.

As a result of taking the drug, the patient may develop a dry cough, tachycardia, shortness of breath, stomach pain, diarrhea, nausea, cyanosis, chest pain, vomiting, drowsiness, sweating, hiccups. Among the side effects, the occurrence of an allergic reaction, back pain, joint pain, necrosis of the renal tubules, and increased salivation are also noted.

Contraindications

The drug should not be taken in diabetes mellitus, renal failure, anaphylactic shock, acute stage of allergy. With caution, the drug is prescribed to pregnant women, during lactation, with chronic decompensated heart failure, migraines.

If a pregnant woman has an Rh-negative blood type, and the father of the unborn child is positive, and the fetus inherits his Rh factor, an Rh conflict may occur. To exclude the development of complications against this background, a woman is given immunoglobulin during pregnancy.

This measure reduces the risk of hemolytic disease of the newborn. In addition, it gives the necessary protection in subsequent pregnancies and reduces the risk of Rhesus conflict between mother and fetus.

During the first pregnancy, conflict rarely occurs, since antibodies work like allergens when they first start to be produced. Further, their accumulation occurs and with each subsequent pregnancy, the titer of the content of antibodies increases, which leads to the destruction of erythrocytes in the fetus. All this leads to hemolytic disease, which is accompanied.

In order to prevent Rh conflict during pregnancy, anti-Rhesus immunoglobulin is used.

Anti-D-immunoglobulin is an active protein fraction of human plasma. Contains IgG with incomplete anti-Rho(D) antibodies. The maximum concentration of the drug reaches a day after administration.

If the mother has negative blood and the father has positive blood, it is necessary to register with the antenatal clinic before 12 weeks of pregnancy, when the first tests are done, so you need to ask the doctor about the need to administer immunoglobulin even when planning pregnancy.

Subsequently, the antibody titer is determined once every 28 days with a negative content. After the 30th week of pregnancy, antibodies are determined once every 14 days, and after the 36th week - once every 7 days.

The introduction of the drug after childbirth is necessary to reduce the formation of antibodies during repeated pregnancies.

It is not necessary to administer immunoglobulin G during pregnancy and after childbirth if the father of the child has an Rh-negative blood type.

Indications and contraindications for the use of immunoglobulin during pregnancy

The circulatory systems of the mother and fetus work offline: their blood does not mix with each other. Rhesus conflict can occur when the placental barrier is damaged.

Human immunoglobulin during pregnancy is used to prevent isoimmunization of a woman with:

• amniocentesis;
• cordacentese;
• injuries of the abdominal organs;
• the birth of a Rh-positive child;
• positive blood of the father of the child;
• prevention of Rhesus conflict during the first pregnancy in the absence of sensitization of the woman;
• premature;
• severe form;
• a number of infectious lesions;
• diabetes.

Among the contraindications to the use of immunoglobulin during pregnancy are:

• allergic reactions;
• negative blood type in women who are sensitized with the presence of antibodies;
• a positive Rh factor in a woman.

Application methods

Normal human immunoglobulin during pregnancy is administered intramuscularly once. One dose of the drug is 300 μg of anti-D immunoglobulin if the antibody titer is within 1:2000, or 600 μg if the antibody titer is 1:1000.

It is forbidden to give an intravenous injection of immunoglobulin G during pregnancy.

Before use, it is necessary to leave the drug at a temperature of 18-22 ° C for 2 hours. To avoid foam, the immunoglobulin is drawn into the syringe with a wide lumen needle. The opened ampoule should be used immediately. Keeping it open is unacceptable.

The introduction of the drug is carried out according to the following scheme:

• a woman receives an injection within 48-72 hours after the birth of a child;
• an injection of immunoglobulin during abortion is performed after an abortion for a period of more than 8 weeks.

If there are no antibodies in blood tests, immunoglobulin is administered at the 28th week of pregnancy for prophylactic purposes. Further, the drug is injected after childbirth within 48 hours in the case when the Rh factor of the child is positive. If the child has negative blood, then repeated administration of immunoglobulin is not required.

If an Rh-negative woman is at risk of miscarriage, 1 dose of anti-D-immunoglobulin should be administered during pregnancy.

For prophylactic purposes, an additional injection is prescribed during the bearing of a child, if an amniocentesis is performed, or a woman has an abdominal injury. Further, the drug is administered at the specified time.

Effects

The introduction of human normal immunoglobulin during pregnancy may be accompanied by a number of side effects, among which the most important are:

• redness of the injection site;
• an increase in body temperature up to 37.5 ° C in the first 24 hours after the injection;
• dyspeptic disorders;
• allergic reactions, including anaphylactic shock.

Due to the fact that the drug is highly allergenic, after its use, a half-hour monitoring of the woman's condition is established. If an anaphylactic or allergic reaction develops, first aid drugs are administered.

Measures to prevent Rh conflict

To prevent the development of Rh-conflict during pregnancy, it is necessary:

• register for pregnancy up to 12 weeks;
• if the mother has Rh-negative blood, take an analysis to determine the Rh factor from the father of the child;
• with a Rh-positive father, administer immunoglobulin in time;
• with a Rh-negative father - do not vaccinate;
• administer immunoglobulin during the second pregnancy and subsequent, if the mother is not sensitized;
• administer the drug for any termination of pregnancy.

If an Rh-negative woman and an Rh-positive man are planning a pregnancy, it is necessary to undergo a series of medical examinations to prevent Rh conflict. To reduce the risk of developing hemolytic disease of the newborn, immunoglobulin is given to the mother at 28 weeks' gestation. Further - according to indications in the postpartum period, if the child has inherited a positive Rh factor.

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.

Human normal 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 soon 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.

Formula, chemical name: no data.
Pharmacological group: immunotropic agents / immunoglobulins.
Pharmachologic effect: immunomodulatory.

Pharmacological properties

The drug mainly consists of class G immunoglobulins (antibodies to various pathogens of infectious diseases). The subclasses of immunoglobulin G in the preparation have the same distribution as in normal blood plasma and have all the properties that are characteristic of a healthy person. The drug restores the low level of immunoglobulin G to its normal value. Immunoglobulin G molecules do not change due to enzymatic or chemical action, the activity of antibodies is fully preserved. When administered intravenously, the drug immediately enters the systemic circulation, quickly distributed between the extravascular space and blood serum. After 3-5 days, an equilibrium state is reached. The half-life is approximately 24-36 days, may vary in different patients, especially in patients with primary immunodeficiency. The drug is destroyed by cells of the reticuloendothelial system.

Indications

Primary immunodeficiency (unclassified variable immunodeficiency, congenital agammaglobulinemia and hypogammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies); chronic lymphoid leukemia or multiple myeloma with recurrent infections and severe secondary hypogammaglobulinemia; children with congenital HIV infection with recurrent infections; Guillain-Barré syndrome; bone marrow transplantation; Kawasaki disease; idiopathic thrombocytopenic purpura in adults and children before surgery or with a high risk of bleeding to adjust the platelet count.

Method of application of human normal immunoglobulin and dose

Doses, route of administration, duration of treatment are set individually, depending on the indications and pharmacokinetic parameters in a particular patient.
During and after the administration of the drug, careful monitoring of the patient's condition is necessary.
All patients receiving intravenous immunoglobulins need adequate hydration before administration of the drug, exclude the use of loop diuretics, control diuresis, serum creatinine concentration.
High doses of immunoglobulin may increase plasma viscosity and increase the risk of thromboembolic complications and ischemia.
More often, side effects develop with a high rate of administration, a- and hypogammaglobulinemia, administration of the drug for the first time, transfer to the administration of another immunoglobulin, after a long period of time after the last administration of the drug.
During treatment, false-positive results of serological tests are possible due to a transient increase in various passively transferred antibodies in the patient's blood.
Passive transfer of antibodies to erythrocyte antigens can affect some serological tests with erythrocyte allo-antibodies (Coombs test), haptoglobin and reticulocyte counts.
When using medicines that are made from human blood and plasma, infectious diseases due to transmission from pathogens cannot be completely excluded.

Contraindications for use

Hypersensitivity or intolerance to homologous immunoglobulins, especially in immunoglobulin A deficiency, when patients have antibodies to immunoglobulin A.

Application restrictions

No data.

Use during pregnancy and lactation

Clinical trials on the safety of using the drug during pregnancy have not been conducted (therefore, the drug must be used with caution), but clinical experience with the use of immunoglobulins shows that their administration does not have any negative effects on the course of pregnancy, fetus, newborn. Immunoglobulins pass into breast milk, and antibodies may have a protective effect in the baby.

Side effects of normal human immunoglobulin

The cardiovascular system: hypotension, myocardial infarction, palpitations, tachycardia, cyanosis, peripheral circulatory failure, thrombosis, hypertension.
The immune system: hypersensitivity reactions, anaphylactic and anaphylactoid reactions (including anaphylactic shock), facial edema, angioedema.
Blood and lymphatic system: transient hemolytic anemia, leukopenia, hemolysis.
Nervous system: headache, agitation, aseptic meningitis, cerebrovascular accident (including stroke), migraine, paresthesia, dizziness.
Digestive system: nausea, diarrhea, vomiting, abdominal pain, elevated liver enzymes.
Respiratory system: respiratory failure, pulmonary edema, pulmonary embolism, shortness of breath, bronchospasm, cough.
Musculoskeletal system: back pain, myalgia, arthralgia.
Skin covers: eczema, urticaria, dermatitis, itching, rash (including erythematous), alopecia.
Urinary system: increased concentration of creatinine in the blood, acute renal failure.
Others: fatigue, fever, injection site reactions, chest pain, chills, flushing, hyperhidrosis, pyrexia, malaise, false-positive elevation of blood glucose.

Interaction of normal human immunoglobulin with other substances

Do not use the drug in conjunction with calcium gluconate in infants. The drug must not be mixed with other agents and a separate intravenous system must be used for its administration. The drug may reduce the effectiveness of live attenuated viral vaccines (against smallpox, measles, rubella, chicken pox, mumps). Therefore, after using the drug, at least 3 months must pass before vaccination with live attenuated vaccines. For measles, this effect can last up to 1 year.

Overdose

With an overdose of the drug, water retention in the body develops, an increase in blood viscosity (especially in patients with impaired renal function and in elderly patients). Symptomatic treatment is necessary.

• Gabriglobin
• Gabriglobin-IgG
• Gamimun N
• Gamunex
• Imbioglobulin
• Immunovenin
• normal human immunoglobulin
• intraglobin

Indications for use

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.

Dosage and administration

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 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.

Contraindications

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, dyspepsia, arterial hypo- or hypertension, tachycardia, shortness of breath. In extremely rare cases, with individual intolerance, anaphylactic reactions may develop. Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.

Side effects

Headache, nausea, dizziness, vomiting, abdominal pain, diarrhea, arterial hypo- or hypertension, tachycardia, cyanosis, shortness of breath, feeling of pressure or pain in the chest, allergic reactions; rarely - severe hypotension, collapse, loss of consciousness, hyperthermia, chills, increased sweating, fatigue, malaise, back pain, myalgia, numbness, hot flashes or a feeling of cold.

Pharmacological group

Immunoglobulins

pharmachologic effect

Immunostimulating. Increases the content of antibodies in the body. With intravenous infusion, bioavailability is 100%. A redistribution of the drug occurs between the plasma and the extravascular space, and 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. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replenishment of the missing IgG antibodies, which reduces the risk of infection.

Compound

The active ingredient is normal human immunoglobulin.

Interaction

Transfusion therapy with intravenous immunoglobulin can be combined with other drugs, in particular antibiotics. The introduction of immunoglobulins can weaken (for 1.5-3 months) the effect of live vaccines against viral diseases such as measles, rubella, mumps and chicken pox (vaccinations with these vaccines should be carried out no earlier than 3 months later). After the introduction of large doses of immunoglobulin, its effect can last up to one year in some cases. Do not use simultaneously with calcium gluconate in infants.

special instructions

For persons suffering from autoimmune diseases (diseases of the blood, connective tissue, nephritis), the drug should be administered against the background of appropriate therapy. Immunoglobulin passes into breast milk and may facilitate the transfer of protective antibodies to the newborn. After the administration of the drug, the patient's condition should be observed for at least 30 minutes. In the room where the drug is administered, anti-shock therapy must be available. With the development of anaphylactoid reactions, antihistamines, glucocorticosteroids and adrenomimetics are used. A temporary increase in the level of antibodies in the patient's blood after the introduction of immunoglobulin can cause false positive results of serological tests. Do not exceed the rate of intravenous administration due to the possibility of developing collaptoid reactions.

Storage conditions

At a temperature of 2-8 °C. Refrigerate (do not freeze).