Intramuscular immunoglobulin. Normal human immunoglobulin, solution for intravenous administration

The product is also used for:
- thrombocytopenic purpura of immune origin;
- heavy bacterial infections, such as sepsis (in combination with antibiotics);
- viral infections;
- prevention of various infectious diseases in premature infants;
- Guillain-Barre syndrome;
- Kawasaki syndrome (usually in combination with the standard diseases for this disease);
- neutropenia of autoimmune origin;
- chronic demyelinating polyneuropathy;
- hemolytic anemia autoimmune origin;
- erythrocyte aplasia;
- thrombocytopenia of immune origin;
- hemophilia caused by the synthesis of antibodies to factor P;
- treatment of myasthenia gravis;
- prevention of recurrent miscarriage.

Pharmachologic effect:
The drug is an immunomodulatory and immunostimulating agent. Contains a large number of neutralizing and opsonizing antibodies, thanks to which it effectively resists viruses, bacteria and other pathogens. The product also replenishes the number of missing IgG antibodies, thereby reducing the risk of infection in persons with primary and secondary immunodeficiency. Immunoglobulin effectively replaces and replenishes natural antibodies in the patient's serum.

When administered intravenously, the bioavailability of the drug is 100%. There is a gradual redistribution of the active substance of the product between the extravascular space and human plasma. Equilibrium between these environments is achieved in approximately 1 week.

Immunoglobulin method of administration and dosage:
Immunoglobulin is administered intravenously by drip and intramuscularly. The dosage is prescribed strictly individually, taking into account the type and severity of the disease, the individual tolerance of the patient and his condition. immune system.

Immunoglobulin contraindications:
The drug should not be used for:
- hypersensitivity to human immunoglobulins;
- IgA deficiency due to the presence of antibodies to it;
- renal failure;
- exacerbation of the allergic process;
- diabetes mellitus;
- anaphylactic shock to blood products.

The product should be used with caution for migraines, pregnancy and lactation, and decompensated chronic heart failure. Also, if there are diseases in the genesis of which immunopathological mechanisms are the main ones (nephritis, collagenosis, immune blood diseases), then the product should be prescribed with caution following the conclusion of a specialist.

Immunoglobulin side effects:
If all recommendations for administration, dosage and precautions are followed when using the product, then the presence of serious side effects is very rare. Symptoms may appear several hours or even days after administration. Almost always side effects disappear after stopping taking Immunoglobulin. Main part side effects associated with a high rate of product infusion. By reducing the speed and temporarily stopping the intake, you can achieve the disappearance of most of the effects. In other cases it is necessary to carry out symptomatic therapy.

Effects are most likely to occur when you first take the product: during the first hour. This may be a flu-like syndrome - malaise, chills, heat body, weakness, headache.

There are also following symptoms from the side:
- respiratory system(dry cough and shortness of breath);
- digestive system(nausea, diarrhea, vomiting, stomach pain and increased salivation);
cardiovascular system (cyanosis, tachycardia, pain in chest, flushed face);
- central nervous system(drowsiness, weakness, rarely symptoms of aseptic meningitis - nausea, vomiting, headache, light sensitivity, impaired consciousness, stiff neck);
- kidneys (not often acute necrosis tubules, worsening renal failure in patients with impaired renal function).

Allergic reactions (itching, bronchospasm, skin rash) and local (hyperemia in the area intramuscular injection) reactions. Other side effects include: myalgia, aching joints, back pain, hiccups and sweating.

In very rare cases, collapse, loss of consciousness and severe hypertension have been observed. In these severe cases, discontinuation of the product is necessary. It is also possible to administer antihistamine products, adrenaline and plasma replacement solutions.

Pregnancy:
No studies have been conducted on the effect of the product on pregnant women. There is no information about the dangers of Immunoglobulin during pregnancy and lactation. But during pregnancy, this product is administered in cases of extreme need, when the benefits of the drug significantly exceed possible risk for the baby.

The product should be used with caution during lactation: it is known to penetrate into mother's milk and promotes transmission protective antibodies infant.

Overdose:
Symptoms of overdose may appear with intravenous administration of the product - high blood viscosity and hypervolemia. This is especially true for people who are elderly or have impaired renal function.

Use with other medications:
The drug is pharmaceutically incompatible with other drugs. It should not be mixed with other products; a separate dropper should always be used for infusion. At simultaneous use Immunoglobulin with active immunization preparations for such viral diseases, such as rubella, chickenpox, measles, and mumps may reduce the effectiveness of treatment. If parenteral use of live viral vaccines is necessary, they can be used after at least 1 month after taking Immunoglobulin. A more desirable waiting period is 3 months. If a large dose of Immunoglobulin is administered, its effect can last for a year. Also, this product should not be used in conjunction with calcium gluconate in infants. There are suspicions that this will lead to negative phenomena.

Release form:
The drug is available in two forms: lyophilized dry powder for infusion (IV administration), solution for IM injection.

Storage conditions:
The drug must be stored in a warm place, protected from light. The storage temperature should be 2-10°C; the medicine should not be frozen. The storage period will be indicated on the package. After this period, the product cannot be used.

Synonyms:
Immunoglobin, Imogam-RAZH, Intraglobin, Pentaglobin, Sandoglobin, Cytopect, Human normal immunoglobulin, Human antistaphylococcal immunoglobulin, Immunoglobulin against tick-borne encephalitis human liquid, Human tetanus immunoglobulin, Venoglobulin, Imbiogam, Imbioglobulin, Normal human immunoglobulin (Immunoglobulinum Humanum Normale), Sandoglobulin, Cytotect, Humaglobin, Octagam, Intraglobin, Endobulin S/D

Immunoglobulin composition:
Active substance product – immunoglobulin fraction. It was isolated from human plasma, and then purified and concentrated. Immunoglobulin does not contain antibodies to hepatitis C viruses and human immunodeficiency, it does not contain antibiotics.

Additionally:
The drug should be used only as prescribed by a doctor. Do not use Immunoglobulin in damaged containers. If the transparency of the solution changes, flakes and suspended particles appear, then such a solution is unsuitable for use. When opening the container, the contents must be used immediately, since the already dissolved product cannot be stored.

Protective action of this product begins to appear 24 hours after administration, its duration is 30 days. In patients with a tendency to migraine or with impaired renal function, increased caution must be exercised. You should also know that after using Immunoglobulin, there is a passive increase in the amount of antibodies in the blood. In serological testing, this may lead to false interpretation of the results.

The drug is dispensed from pharmacies according to a doctor's prescription.

Attention!
Before using the medication "Immunoglobulin" You should consult your doctor.
The instructions are provided for informational purposes only. Immunoglobulin».

Thank you

Immunoglobulins(antibodies, gamma globulins) are special compounds produced by cells of the immune system that protect humans from bacteria, viruses and other foreign substances (antigens).

Properties of immunoglobulins

The human immune system and its functions

Humoral immunity is that part of the immune system that carries out its function in liquid media human body. Those. Antibodies perform their work in the blood, interstitial fluids and on the surface of mucous membranes.

There is also cellular immunity carried out by a number of specialized cells (such as macrophages). However, it has nothing to do with immunoglobulins and is a separate element of protection.

The immune response may be:
1. Specific.
2. Non-specific.

Immunoglobulin carries out a specific immune response, finding and neutralizing foreign microorganisms and substances. Each bacteria, virus or other agent produces its own monoclonal antibodies (i.e., capable of interacting with only one antigen). For example, antistaphylococcal immunoglobulin will not help against diseases caused by other microorganisms.

Acquired immunity can be:
1. Active:

• is formed due to antibodies formed after an illness;
• occurs after preventive vaccination(introduction of weakened or killed microorganisms, or their modified toxins, in order to form an immune response).

• immunity in the fetus and newborn child, to whom maternal antibodies were transferred in utero, or during breastfeeding;
• occurs after ready-made immunoglobulins have been vaccinated against a specific disease.

Human immunoglobulin and its functions

• “recognizes” a foreign substance (microorganism or its toxin);
• binds to antigen, forming an immune complex;
• participates in the removal or destruction of formed immune complexes;
• immunoglobulin against past diseases remains in the body for a long time (sometimes for life), which protects a person from re-infection.

Antibodies are actively used in medicines. Currently, you can buy immunoglobulin in almost any pharmacy.

Immunity and immunoglobulins in children

• In utero, the child does not encounter microorganisms, so his own immune system is practically inactive;
• during pregnancy, only class G immunoglobulins can pass from mother to child, easily penetrating the placenta due to their small size;
• detection of class M immunoglobulins in the blood serum of a fetus or newborn child indicates an intrauterine infection. It is often caused by cytomegalovirus (symptoms of the disease: runny nose, fever, enlarged lymph nodes, damage to the liver and spleen, and others);
• immunoglobulins acquired from the mother in the blood of an infant remain for about 6 months, protecting him from various diseases, therefore, in the absence of pathology of the immune system at this time, children practically do not get sick.

The final formation of the child’s immune system is completed only by the age of 7 years. Distinctive Features children's immunity are:
1. Insufficient ability for phagocytosis (absorption and destruction of cells of pathogenic microorganisms by human phagocytes).
2. Low production of interferons (proteins that carry out nonspecific protection against viruses).
3. A decrease in the amount of immunoglobulins of all classes (for example, for immunoglobulin E, the norm in children is lower than in adults).

Therefore, it is natural that during the development of the body’s immune system, the child often gets sick. To help him properly form immunity, increasing it should be achieved by such means as hardening, swimming and other sports activities, and staying in the fresh air.

Immunoglobulins during pregnancy: Rh conflict

The mechanism of development of this pathology is due to the fact that when a pregnant woman is Rh negative, immunoglobulin can begin to be produced against the red blood cells of the fetus. This usually occurs in late pregnancy. The threat of Rh conflict increases with pregnancy pathologies: inflammatory processes, threat of interruption, increased tone uterus and others.

Rh conflict can lead to severe hemolysis (destruction of red blood cells) in the fetus and newborn child. The consequences of this condition may be:

• severe hypoxia (oxygen starvation) of the fetus;
• metabolic disorders, intrauterine growth retardation;
• the appearance of edema, fetal hydrops;
• miscarriages and premature births, fetal death.

Anti-Rhesus immunoglobulin during pregnancy

2. Prevention of the formation of “harmful” immunoglobulins during abortion or other manipulations that can lead to fetal serum entering the mother’s blood.

The price for anti-Rhesus immunoglobulin is quite high, but when we're talking about about the health of a pregnant woman and her child, you should not save. Lower cost distinguishes domestic analogues drugs. Therefore, you can buy anti-Rhesus immunoglobulin Russian production, especially since there are no differences in the mechanism of action of the agents.

Self-medication with medications containing antibodies is contraindicated. During pregnancy, other drugs, with the exception of anti-Rhesus immunoglobulin, are not used.

Determining the level of antibodies in the blood

Blood diseases and hypovitaminosis can also cause immunodeficiency. The most common of these is iron deficiency anemia, characterized by low content hemoglobin in red blood cells, and a decrease in the amount of iron in the blood serum. This condition leads to oxygen starvation tissues and, as a result, decreased immunity. Therefore, when hemoglobin is reduced, infectious diseases often occur. This is especially true for children, pregnant women or elderly patients.

Antibody affinity and avidity

The avidity of antibodies allows us to identify the severity of the disease. For example, acute or recent (1-1.5 months ago) cytomegalovirus infection in children is confirmed by identifying highly avid IgM antibodies, while small concentrations can persist for up to two years.

Affinity refers to the strength of interaction between antigens and antibodies. The higher the indicator, the better the antigens bind to antibodies. Therefore, high affinity indicates a good immune response when this disease occurs.

When is an immunoglobulin test prescribed?

• atopic dermatitis;
• food, drug allergies;
• some other conditions.

A blood test for immunoglobulin G is indicated in the following cases:

• diagnosis of immunodeficiency conditions;
• determining the presence of antibodies against a specific disease;
• monitoring the effectiveness of therapy with drugs containing immunoglobulin.

Analysis of fractions for the determination of class M antibodies is used to identify acute infectious diseases. It is often prescribed to determine cytomegalovirus infection, Epstein-Barr virus, Helicobacter pylori bacteria, which causes gastritis and stomach ulcers, and other infections. Fine total IgM – up to 10% of all immunoglobulins.

A blood test for immunoglobulin A is indicated for recurrent infectious diseases of the mucous membranes. Normal quantity IgA – 10-15% of total number immunoglobulins.

Blood is also donated for immunoglobulin for various autoimmune diseases. Specific antibodies and their complexes with antigens are determined in pathologies such as systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroiditis, myasthenia gravis and others.

Human immunoglobulin: application

• immunodeficiency states;
• autoimmune diseases;
• severe viral, bacterial, fungal infections;
• prevention of diseases in people at risk (for example, in children born very prematurely).

For severe allergic diseases, your doctor may recommend purchasing antiallergic immunoglobulin. This drug is effective means from atopic reactions. Indications for use will be:

• allergic dermatitis, neurodermatitis, urticaria, Quincke's edema;
• atopic bronchial asthma;
• hay fever

The importance of antibodies in vaccinations

Antibodies obtained from animals or human immunoglobulin can be used to produce preparations for passive immunization.
Immunoglobulin is included in preventive vaccinations against the following diseases:

• mumps (mumps);
• other.

A separate variant of immunoglobulins is toxoid. It is an antibody whose action is directed not at the causative agent of the disease, but against toxic substances, produced by him. For example, toxoids are used against tetanus and diphtheria.

There are also emergency prophylaxis products containing human immunoglobulin. Their price will be an order of magnitude higher, but they are indispensable when there is a need to travel to another country that is an endemic zone of some kind. dangerous infection(eg yellow fever). Immunity after the introduction of these drugs will be shorter (up to 1 month), but is formed within a day.

However, it should be remembered that the administration of immunoglobulin is not an alternative to full preventive vaccination in accordance with the vaccination calendar, since the emerging immunity is shorter lasting and not as strong.

Immunoglobulin preparations

Human normal immunoglobulin is available in bottles containing powder for the preparation of a solution for injection or ready solution(Immunoglobulin 25 ml). It contains IgG antibodies obtained from the plasma of healthy donors, as well as small amounts of IgM and IgA.

Normal human immunoglobulin is contained in the following medications: Octagam, Pentaglobin, Antirotavirus immunoglobulin, Antistaphylococcal immunoglobulin, Normal human immunoglobulin, Complex immunoglobulin preparation (CIP), Antirhesus immunoglobulin, Antiallergic immunoglobulin, Cytotect and many others.

Immunoglobulin injections are prescribed intramuscularly or intravenously only by a qualified doctor. The dose of the drug and duration of treatment are selected individually, taking into account the patient’s age and weight, as well as the severity of the disease.

Treatment with immunoglobulins

• severe allergic reactions;
• flu-like symptoms (chills

  Where can I buy?

  You can purchase the drug at any large pharmacy or on the Internet. Medicines containing immunoglobulin must be accompanied by instructions. However, using them without a doctor’s prescription is strictly prohibited, since the drugs have a large number of contraindications. For example, during pregnancy and breastfeeding, immunoglobulin administration is prohibited.

  The price of immunoglobulin preparations can vary greatly and depends on the specificity of the antibodies, the manufacturer of the drug, the release form and other characteristics.

  Any medications containing normal human immunoglobulin must be stored in the refrigerator (at a temperature of +2 - +8 o C).

  Before use, you should consult a specialist.

Human immunoglobulin is an immunological drug. 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 temperatures below 0°C.

Everything has been created at the Yusupov Hospital the necessary conditions for treating patients. In the therapy clinic, comfortable rooms are equipped with forced-air ventilation and air conditioning. This allows for comfortable temperature regime. Professors and doctors highest category are leading immunologists.

Patients are examined using modern equipment. Immunoglobulins registered in the Russian Federation are used to treat patients. They have high efficiency and a minimal range of side effects. Patients are provided with individual personal hygiene products and dietary nutrition.

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

Instructions for use of human immunoglobulin

The active ingredients of normal human immunoglobulin are immunoglobulins, which 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 administration of the drug. The half-life of antibodies is 4-5 weeks.

Normal human immunoglobulin (instructions are in the box) is available in the form of a solution in 1.5 ml ampoules (1 dose). One package may contain 5, 10 or 20 ampoules of the drug. The kit includes an ampoule nail file. The drug is dispensed in pharmacies with a doctor's prescription. Immunoglobulin in ampoules is transported and stored at air temperatures from +2 to +8 o C.

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

To prevent foam from forming in the syringe, the drug is drawn into the syringe with a wide-bore needle. It is injected by changing the needle. The drug in an opened ampoule cannot be stored. At the Yusupov Hospital, patients are not administered immunoglobulin if the integrity or labeling of the ampoules is damaged. The drug is unsuitable for use if the solution becomes cloudy, changes color, has flakes that do not break, as well as immunoglobulin that was stored in improper conditions or has 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;
• polio.

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 for patients suffering from systemic immunopathological diseases - diseases connective tissue, blood pathology, nephritis. The use of 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. 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 re-introduce immunoglobulin if it is necessary to prevent hepatitis A no earlier than 2 months after the first injection.

To prevent measles, human immunoglobulin is administered once to children from three years of age. one month old and adults who have not had measles and have not been vaccinated against this infection. The injection is given 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 health status. If adults or children have been in contact with mixed infections, they are administered 3 ml of the drug.

To prevent and treat mild forms of influenza, a single injection of human immunoglobulin is sufficient. Children under 2 years old are administered 1.5 ml of the drug, from 2 to 7 years old - 3 ml, over 7 years old and adults - 4.5-6 ml. Sick severe form influenza, after 24-48 hours the same dose of immunoglobulin is re-administered. 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 early 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 administered intramuscularly with 1.5 ml or 3 ml of the drug. To prevent polio in unvaccinated or incompletely vaccinated children with polio vaccine, take a single dose of 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 administrations of immunoglobulin, if indicated, are carried out no earlier than 1 month later. During the period of convalescence (recovery) of acute infectious diseases with a protracted course and during chronic pneumonia the drug is administered to increase the body's resistance. Per 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 an immunologist at 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 day after administration of the drug, body temperature may rise to 37.5°C or skin redness may appear at the injection site. Patients with altered reactivity rarely develop allergic reactions various types, and in extremely rare cases - anaphylactic shock. In this regard, after the administration of simple immunoglobulin, patients are under the supervision of a doctor at the Yusupov Hospital for 30 minutes. The manipulation room is equipped with anti-shock therapy.

Call the clinic and make an appointment with an immunologist. The doctor will determine the indications and contraindications for the use of human immunoglobulin and draw up an individual prevention or treatment plan.

Bibliography

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

Prices for diagnostic tests

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

Normal human immunoglobulin

Instructions for use

Human immunoglobulin normal, solution for intramuscular administration.

R N001544/01 dated 07/08/2008

The drug is a concentrated solution of an immunologically active protein fraction, isolated by fractionation with ethyl alcohol at temperatures below 0°C from the blood plasma of healthy donors. To produce a series of immunoglobulins, plasma obtained from at least 1000 healthy donors is used, individually tested for the absence of hepatitis B virus surface antigen (HBsAg), antibodies to the hepatitis C virus and the human immunodeficiency viruses HIV-1 and HIV-2.

The protein concentration in immunoglobulin ranges from 9.5 to 10.5%.

Stabilizer glycine at a concentration of (2.25±0.75)%. The drug does not contain preservatives or antibiotics.

Transparent or slightly opalescent liquid, colorless or slightly yellow. During storage, a slight sediment may appear, which disappears after lightly shaking the drug at a temperature of (20±2)°C.

Immunological properties.

The active principle is immunoglobulins, which have antibody activity of various specificities.

The maximum concentration of antibodies in the blood is achieved after 24 - 48 hours; The half-life of antibodies from the body is 3 to 4 weeks. The drug also has nonspecific activity, increasing the body's resistance.

Purpose.

Prevention of hepatitis A, measles, whooping cough, meningococcal infection, polio, influenza, treatment of hypo- and agammaglobulinemia; increasing the body's resistance during the period of convalescence of infectious diseases.

Directions for use and dosage.

Immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteal muscle or into outer surface hips. The drug should not be administered intravenously. Before injection, ampoules with the drug are kept for 2 hours at room temperature.

The opening of the ampoules and the administration procedure are carried out in strict compliance with the rules of asepsis and antiseptics. To avoid foam formation, the drug is drawn into a syringe with a wide bore needle.

The drug cannot be stored in an opened ampoule. The drug is unsuitable for use in ampoules with damaged integrity or labeling, if the physical properties(change in color, cloudiness of the solution, presence of flakes that do not break), if the expiration date has expired and storage conditions have not been observed.

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 old - 0.75 ml: 7-10 years old - 1.5 ml; over 10 years old and adults - 3 ml.

Repeated administration of immunoglobulin if necessary to prevent hepatitis A is indicated no earlier than after 2 months.

Prevention of measles.

The drug is administered once from the age of 3 months to those who have not had measles and have not been vaccinated against this infection, no later than 6 days after contact with the patient. The dose of the drug for children (1.5 or 3 ml) is determined depending on the state of health and the time that has passed since contact. For adults, as well as children in contact with mixed infections, the drug is administered in a dose of 3 ml.

Prevention and treatment of influenza.

The drug is administered once in doses: children under 2 years old - 1.5 ml, from 2 to 7 years old - 3 ml, over 7 years old and adults - 4.5-6 ml. During treatment severe forms influenza, repeated (after 24-48 hours) administration of immunoglobulin in the same dosage is indicated.

Prevention of whooping cough.

The drug is administered twice with an interval of 24 hours in a single dose of 3 ml to children who have not had whooping cough and have not been vaccinated (not fully vaccinated) against whooping cough, as early as possible 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 no later than 7 days after contact with a patient with a generalized form of meningococcal infection in doses of 1.5 ml (children under 3 years old) and 3 ml (children over 3 years old).

Prevention of polio.

The drug is administered once in a dose of 3 - 6 ml to children who have not been vaccinated or who have been incompletely vaccinated with the polio vaccine as early as possible after contact with a patient with polio.

Treatment of hypo- and agammaglobulinemia in children.

The drug is administered at a dose of 1 ml per kg of body weight: the calculated dose can be administered in 2-3 doses with an interval of 24 hours. Subsequent administrations of immunoglobulin are carried out according to indications no earlier than after 1 month.

Increasing the body's resistance during the period of convalescence of acute infectious diseases with a protracted course and in chronic pneumonia.

The drug is administered in a single dose of 0.15-0.2 ml per kg of body weight. The frequency of administration (up to 4 injections) is determined by the attending physician, the intervals between injections are 2 - 3 days.

Side effects.

As a rule, there are no reactions to the administration of immunoglobulin. In rare cases, they may develop local reactions in the form of hyperemia and an increase in temperature to 37.5 ° C during the first day after administration of the drug. U individuals with altered reactivity, allergic reactions of various types may develop, and in extremely rare cases, anaphylactic shock; therefore, persons who have been administered the drug should be under medical supervision for 30 minutes after its administration. Vaccination sites must be provided with anti-shock therapy.

Interactions with other drugs.

Not installed.

Contraindications.

The use of immunoglobulin is contraindicated for persons with a history of severe allergic reactions to the administration of human blood products.

Persons suffering allergic diseases or those who have a history of severe allergic reactions, it is recommended to prescribe antihistamines on the day of immunoglobulin administration and for the next 3 days.

Persons suffering from systemic immunopathological diseases, blood diseases, connective tissue, nephritis, etc., immunoglobulin should be administered against the background of appropriate therapy.

Immunoglobulin is used only as prescribed by a doctor. The administration of immunoglobulin is recorded in established accounting forms indicating the batch number, date of manufacture, expiration date, manufacturer, date of administration, dose, nature of the reaction to the administration of the drug.

Administration of immunoglobulin and preventive vaccinations.

After administration of immunoglobulin vaccination against measles and mumps carried out no earlier than after 3 months. After vaccination against these infections, immunoglobulin should be administered no earlier than 2 weeks later; If it is necessary to use immunoglobulin earlier than this period, vaccination against measles or mumps should be repeated. Vaccinations against other infections can be carried out at any time before or after the administration of immunoglobulin.

Release form.

In ampoules of 1.5 ml (1 dose) and 3 ml (2 doses). A) 10 ampoules in a cardboard pack with instructions for use. B) 5 or 10 ampoules in blister packs, 1 or 2 blister packs in a cardboard pack with instructions for use, an ampoule knife or an ampoule scarifier.

Country of origin

Product group

Medical immunobiological drug(MIBP) - globulin

Release forms

• 2 ml (2 doses) - ampoules (10) - cardboard packs. 1 ml (1 dose) - ampoules (10) - cardboard packs. 1.5 ml - ampoules (10) - cardboard packs 25 ml - bottles (1) - cardboard packs. 300 mg - bottles (5) - cardboard packs. 5 bottles. Bottles with a capacity of 25 ml (1) - cardboard packs. Lyophilisate for preparing a solution for oral administration - 5 bottles. Solution for intramuscular administration - 10 ampoules per pack. solution for intramuscular administration 300 mcg/ml - 1 ml - 1 ampoule Vials (5) - cardboard packs.

Description of the dosage form

• Amorphous mass of white or bluish color. Lyophilisate for the preparation of solution for oral administration. Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, slight sediment may appear, which disappears after gentle shaking. Transparent or slightly opalescent liquid, colorless or slightly yellow in color. A slight sediment may appear, which disappears when shaken. Solution for intravenous administration Solution for intravenous administration is transparent or slightly opalescent, colorless Solution for intramuscular administration Solution for intramuscular administration is transparent or slightly opalescent, colorless or slightly yellow in color; During storage, a slight sediment may appear, which disappears with gentle shaking.

pharmachologic effect

Pharmacokinetics

Special conditions

Compound

• 1 dose of normal human immunoglobulin 1.5 ml 1 dose of human immunoglobulin G, which has antiallergic activity, of the total protein mass of at least 97% Excipients: glycine (stabilizer) 22.5 ± 7.5 mg. 1 dose (ampoule): Active substance: -antialphastaphylolysin - not less than 100 IU. Excipient: - stabilizer - glycine (aminoacetic acid) - (2.25±0.75)%; The drug does not contain preservatives or antibiotics. Immunoglobulin (protein) 10%, aminoacetic acid 2%, water for injection. normal human immunoglobulin 300 mg, including IgG 50-70% IgM 15-25% IgA 15-25% lyophilized powder for the preparation of a solution for enteral use, stabilizer - glycine at a concentration of 3% COMPOSITION PER DOSE Active substance Immunoglobulin complex preparation (immunoglobulins G, A, M) - 300 mg Excipient Glycine - 100 mg

Immunoglobulin indications for use

• The drug is used only as prescribed by a doctor. Human immunoglobulin anti-Rhesus Rh o (D) is used in Rh-negative women who are not sensitized to the Rh o (D) antigen (i.e., have not developed Rh antibodies) under the condition of the first pregnancy and the birth of a Rh-positive child whose blood is compatible with mother's blood according to ABO blood groups. The drug is used for artificial termination of pregnancy in Rhesus -negative women, also not sensitized to Rh o (D) antibody, in the case Rh positive belongings of the husband's blood.

Immunoglobulin contraindications

• - Immunoglobulin is not administered to persons with a history of allergic reactions to blood products. (In cases of severe sepsis, the only contraindication for administration is a history of anaphylactic shock to blood products); - For persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, the drug is administered against the background antihistamines. It is recommended to continue their administration for 8 days after the end of the course of treatment. During the period of exacerbation of the allergic process, the drug is administered according to the conclusion of an allergist for health reasons. - Persons suffering from diseases in the genesis of which immunopathological mechanisms are leading ( systemic diseases connective tissue, immune blood diseases, glomerulonephritis), the drug is prescribed after consultation with an appropriate specialist.

Immunoglobulin dosage

• 300 mg 300 mcg/dose

Immunoglobulin side effects

• During treatment, some patients may experience a slight and short-term exacerbation of the underlying disease; in rare cases, during the first day after administration, local reactions in the form of hyperemia may develop, as well as an increase in temperature to 37°C, which is not a reason to stop administering the drug. When pronounced general reactions(low blood pressure, weakness, nausea, dizziness), as well as severe exacerbation of the underlying disease, treatment with the drug is stopped. Immunoglobulin treatment is discontinued in the event of the development of intercurrent diseases (influenza, acute respiratory diseases). The patient should be warned about the need to inform the attending physician about all cases of adverse reactions that develop during the course of treatment with the drug.

Drug interactions

Overdose

Storage conditions

• store in a dry place
• store in a cool place 5-15 degrees
• Store refrigerated (t 2 - 5)
• store at room temperature 15-25 degrees
• keep away from children
• store in a place protected from light