Immunoglobulin - instructions for use. Human immunoglobulin normal Immunoglobulin indications for use in children

Normal human immunoglobulin: instructions for use and reviews

Latin name: Immunoglobulinum humanum normale

ATX code: J06BA02

Active substance: human immunoglobulin normal (immunoglobulin human normal)

Manufacturer: NPO Federal State Unitary Enterprise of the Ministry of Health of the Russian Federation "Microgen" (Russia)

Updating the description and photo: 13.08.2019

Human normal immunoglobulin is an immunological agent.

Release form and composition

Dosage forms of normal human immunoglobulin:

• Solution for intramuscular (IM) administration (in ampoules: 1 ml/1 dose, in a cardboard box of 10 pcs.; 1.5 ml/1 dose, in a cardboard box of 10 pcs. or in a contour plastic package of 5 or 10 ampoules, 1 or 2 packs in a cardboard pack; 3 ml/2 doses, 10 pcs in a cardboard pack; 3 ml/1 dose, 10 pcs in a cardboard pack);
• Solution for intravenous (IV) administration (25 or 50 ml bottles, 1 bottle in a cardboard box);
• Solution for infusion (25, 50 or 100 ml bottles, 1 bottle in a cardboard box).

Active substance – normal human immunoglobulin:

• Solution for intramuscular administration: 1 ml – 100 mg;
• Solution for intravenous administration: 1 ml – 50 mg;
• Solution for infusion: 1 ml – 50 mg.

Pharmacological properties

Pharmacodynamics

The composition of normal human immunoglobulin includes approximately 90% monomeric IgG and a small amount of a fraction of decomposition products, dimeric and polymeric IgG and IgA, as well as IgM in trace concentrations. IgG subclasses are distributed into fractions in the same way as in human serum.

The drug contains a wide range of neutralizing and opsonizing antibodies that can fight viruses, bacteria and other pathogens. In patients with primary or secondary immunodeficiency, normal human immunoglobulin compensates for the deficiency of antibodies belonging to the IgG class, which reduces the risk of developing infectious diseases.

Pharmacokinetics

After intravenous infusion, normal human immunoglobulin is redistributed between the extravascular space and blood plasma, and an equilibrium state is achieved in approximately 7 days.

The substance penetrates the placental and blood-brain barriers and is also detected in breast milk. The half-life of immunoglobulin is 21 days. In patients with primary hypogammaglobulinemia (agammaglobulinemia), it increases to 32 days.

Indications for use

The use of normal human immunoglobulin is indicated:

• Solution for intramuscular administration: for the treatment of agamma- and hypoglobulinemia; for the prevention of: whooping cough, measles, hepatitis A, meningococcal infection, influenza, polio; to increase the body's resistance to infectious diseases during the period of convalescence;
• Solution for intravenous administration: treatment of severe forms of viral and bacterial infections; for postoperative complications in adults and children associated with septicemia;
• Solution for infusion: idiopathic thrombocytopenic purpura (especially in acute forms in children), treatment and prevention of infectious diseases, congenital immunodeficiency conditions (partial, complete or variable immunodeficiency, severe forms of combined immunodeficiency, Wiskott-Aldrich syndrome), as well as immunodeficiency acquired in as a result of bone marrow transplantation and other types of transplantations, for chronic lymphocytic leukemia, for AIDS in children, Kawasaki syndrome (as a concomitant therapy with acetylsalicylic acid).

Contraindications

According to the instructions, normal human immunoglobulin in the form of solutions for intramuscular and intravenous administration is contraindicated in the following cases:

• History of severe allergic reactions to the administration of blood products;
• Allergic diseases, including bronchial asthma, atopic dermatitis, recurrent urticaria, as well as a history of a tendency to allergic reactions (for patients in this category, administration of the drug is possible with the simultaneous use of antihistamines, which continue to be administered for 3 days with intramuscular injection and 8 days with intravenous /in the administration of immunoglobulin);
• Systemic immunopathological diseases, including nephritis, blood diseases, connective tissue (if it is necessary to use immunoglobulin, administration should be done only after consultation with an appropriate specialist and against the background of prescribing concomitant therapy).

The solution for intramuscular administration should not be used in infants simultaneously with calcium gluconate.

The use of solution for infusion is contraindicated in patients with selective deficiency of immunoglobulin A (IgA) in the presence of antibodies against IgA and in case of hypersensitivity to the drug.

Caution should be exercised when prescribing the solution for infusion during pregnancy and breastfeeding.

Instructions for use of Normal Human Immunoglobulin: method and dosage

The solution for intramuscular injection is injected into the outer surface of the thigh or the upper outer quadrant of the gluteal muscle (intravenous administration of the drug is prohibited!) Do not store the drug in an opened ampoule, use ampoules with broken markings or seals, if the color of the solution changes or becomes cloudy or the presence of unbreakable flakes, if storage conditions are violated and the expiration date has expired. The ampoules with the drug should be kept at room temperature for 2 hours before administration. The procedure is carried out in compliance with the rules of antiseptics and asepsis. The solution is drawn into a syringe with a wide bore needle to prevent the formation of foam. The dose and frequency of immunoglobulin administration are prescribed by the doctor based on clinical indications.

• Hepatitis A: once, children from 1 to 6 years old at a dose of 0.75 ml, up to 10 years old - 1.5 ml, patients over 10 years old - 3 ml (if necessary, repeated administration is possible only after 2 months);
• Prevention of measles: once, the dose for children depends on the time elapsed since contact with the patient and the condition of the child, and can be 1.5 or 3 ml, in case of contact with mixed infections - 3 ml, adults - 3 ml (indicated for patients from the age of 3 months, who have not had measles and have not been vaccinated against it, no later than 6 days from the moment of contact with the patient);
• Prevention of whooping cough: for children who have not been sick and are not vaccinated or not fully vaccinated against whooping cough - 3 ml twice with a break of 24 hours for the shortest possible time, but no later than 3 days from the moment of contact with the patient;
• Prevention of meningococcal infection: once, for children from 6 months to 3 years in a dose of 1.5 ml, from 3 to 7 years - 3 ml, during the first 7 days after contact with a patient with generalized meningococcal infection;
• Prevention of poliomyelitis: once in doses of 3-6 ml, in children who are not fully or not vaccinated with polio vaccine, at an earlier time after contact with a patient with poliomyelitis;
• For the treatment and prevention of influenza, the solution is administered once: for children under 2 years of age in a dose of 1.5 ml, from 2 to 7 years of age - 3 ml, for patients over 7 years of age - 4.5-6 ml, for severe forms of the disease repeated doses are indicated (after 24 -48 hours) administration of the drug dose;
• When treating agamma- and hypoglobulinemia, the prescription is made in a dose of 1 ml per 1 kg of patient weight (it can be administered in 2-3 doses with a break of 24 hours). Subsequent prescriptions of the drug according to indications are possible only after 1 month;
• To increase the body's resistance in chronic pneumonia and during the period of convalescence during a protracted course of acute infectious diseases, a single dose of 0.15-0.2 ml per 1 kg of patient weight is indicated. The frequency of administration is prescribed by the doctor, but no more than 4 injections with an interval of 2-3 days.

The solution for intravenous administration is diluted immediately before use with 0.9% isotonic sodium chloride solution or 5% glucose solution in a ratio of 1:4. The prepared immunoglobulin solution is administered intravenously at a rate of 8-10 drops per minute, daily for 3-5 days. Without additional dilution, immunoglobulin can be administered intravenously at a rate of 30-40 drops per minute, the course of treatment is 3-10 transfusions, carried out at intervals of 24-72 hours. This method of administration may cause a collapsed state in the patient. Transfusion treatment can be carried out in combination with other drugs. A single dose for children is 3-4 ml per 1 kg of body weight (but not more than 25 ml), for adults - 25-50 ml. The use of the drug should be carried out only in hospital conditions in compliance with the rules of asepsis. Before administration, it is necessary to keep the bottles with the drug for 2 hours at room temperature. Solutions that contain sediment or are cloudy should not be used.

The solution for infusion is administered intravenously; before use, it is recommended to warm the drug to body temperature or room temperature. Only a clear solution can be administered. The initial infusion rate is 30 drops per minute, after 10 minutes the rate is adjusted to 40 drops per minute. Apply:

• Replacement therapy for congenital and secondary immunodeficiency, including children with AIDS: 2-8 ml per 1 kg of patient weight once a month until the level of immunoglobulin increases (in the absence of sufficient dynamics of increase in the level or its very rapid decrease, the intervals between administration should be shortened or increase the dose to 16 ml per 1 kg of weight);
• For allogeneic bone marrow transplantation, the patient is prescribed 10 ml per 1 kg of weight for 7 days;
• For Kawasaki syndrome - 32-40 ml per 1 kg of weight for 2-5 days, or 40 ml per 1 kg - once;
• For idiopathic thrombocytopenic purpura - 16-20 ml per 1 kg of weight, once (if necessary, can be repeated after 2-3 days), or 8 ml per 1 kg of patient weight for 2-5 days (if necessary, the course can be repeated) ;
• For severe viral and bacterial infections, including sepsis – 8-10 ml per 1 kg of weight, daily for 1 to 4 days;
• For premature babies (with low birth weight), to prevent infections, the drug is prescribed with a break of 1-2 weeks, 10-20 ml per 1 kg of baby’s weight;
• For chronic inflammatory demyelinating neuropathy, Guillain-Barré syndrome: 8 ml per 1 kg of weight for 5 days (the course can be repeated with a break of 4 weeks);
• Patients with cerebral ischemia and coronary heart disease: 8 ml per 1 kg, daily.

Side effects

Reactions to intramuscular and intravenous administration of immunoglobulin are usually absent.

In some cases, allergic reactions of various types may develop, including anaphylactic shock. Therefore, patients after administration of the drug should be under the supervision of medical staff for 30 minutes; the room where the drug is administered must be provided with antishock therapy.

In rare cases, with intramuscular administration, local reactions may develop in the form of hyperemia and an increase in temperature during the first day to 37.5°C.

With infusion administration, side effects may develop in the form of chills, headache, nausea, fever, vomiting, back pain, aching joints, and allergic reactions. Rarely - a decrease in blood pressure, in isolated cases - symptoms of aseptic meningitis (nausea, severe headache, vomiting, stiff neck, increased body temperature, photosensitivity and impaired consciousness), anaphylactic shock, worsening existing renal dysfunction.

Overdose

Cases of overdose of normal human immunoglobulin have not been described at the moment. When too high doses are introduced into the body, symptomatic therapy is recommended.

special instructions

Human normal immunoglobulin should be used only as prescribed by a doctor.

Each procedure is registered in established accounting forms indicating the date of issue, batch number, manufacturer, expiration date, date of administration and dose, and the nature of the patient’s reaction to the administration of the drug.

After administration of immunoglobulin, vaccinations against mumps and measles should be carried out no earlier than 3 months later. After vaccination against these diseases, immunoglobulin can be administered no earlier than 2 weeks later. If it is necessary to use immunoglobulin earlier than the specified period, vaccination should be repeated. All other vaccinations are permitted at any time, regardless of the time of administration of the drug.

Normal human immunoglobulin can cause false-positive results in serological tests.

Drug interactions

No clinically significant drug interactions have been established with the solution for IM or IV administration.

The solution for infusion reduces the activity of attenuated live vaccines against rubella, measles, chickenpox, and mumps. If it is necessary to administer immunoglobulin during the first 2 weeks after vaccination against mumps, measles or rubella, vaccination against these diseases must be repeated after 3 months. The solution for infusion can only be mixed with 0.9% sodium chloride solution.

Analogs

Analogues of normal human Immunoglobulin are: Intratect, Intraglobin, Gamimun N, Gamunex, Immunovenin, Pentaglobin, Gabriglobin, Endobulin.

Terms and conditions of storage

Store at 2 to 8 °C, do not freeze. Keep away from children.

Shelf life: solution for intramuscular administration – 2 years, solution for intravenous administration – 1 year.

Or gamma globulins are special proteins distributed in the human blood that are produced by the immune system to specifically protect the body from the effects of various viruses, bacteria and foreign substances.

The drug "Normal human immunoglobulin"

Human immunoglobulin is a medicinal composition created on the basis of blood components from healthy donors - plasma. Donors must be clinically examined. The blood they donate must undergo laboratory testing. It will show that this material does not show signs of infectious diseases that can be transmitted by its components.

It is an immunomodulatory and immunostimulating substance. Due to the content of neutralizing antibodies in its composition, it actively resists various attacks of viruses and bacteria. In its properties, the drug “Normal Human Immunoglobulin” is practically no different from the type G present in tissue fluids, in the secretions produced by human mucous membranes, etc. This comprehensive protection of the body, which has the name - It carries out its work in the liquid media of the human body.

There is also cellular immunity, which is carried out by specialized cells, but this is a completely different defense, and it has nothing to do with immunoglobulins. In addition to the above properties, “Normal Human Immunoglobulin” has a general strengthening and anti-inflammatory effect.

In what cases of diseases is immunoglobulin prescribed?

This medicine is prescribed to replace or replenish a person's natural antibodies. The main indications for its administration are various conditions of the human body, when its own defense is extremely weakened. Such pathologies include:

1. Bone marrow transplantation.
2. Primary and secondary immunodeficiencies.
3. Severe viral and bacterial diseases, etc.

The medicine "Normal human immunoglobulin" has a positive effect. Reviews about it are numerous and contradictory for a variety of infections, inflammatory and chronic diseases. In addition, this drug helps to increase depressed immunity under the influence of medications taken.

Use of intravenous immunoglobulin

Injections of a drug that enhances immunity can be given either intramuscularly or intravenously. It is prescribed for various complications after operations accompanied by sepsis, multiple sclerosis, as well as for preventive actions and treatment of infectious complications in newborns, etc. It is in these cases that the drug “Human Immunoglobulin Normal” is administered. The intravenous method of administering the drug in these cases is the most effective. Instructions for use of the drug describe the basic principles on which the treatment prescribed by the attending physician is carried out, taking into account all indications, the severity of the disease, the state of the patient’s immune system and individual intolerance. To administer the medicine, you need an IV and saline solution. The concentration of human immunoglobulin can be from 3 to 12 percent.

Immunoglobulin injection intramuscularly

Before use, ampoules must be kept at room temperature for 2 hours. Their opening and direct administration of the medicine must be carried out in strict compliance with antiseptic rules.

There are other ways to administer the medicine “Normal Immunoglobulin” to a patient. A person can be injected intramuscularly with this medicine for emergency prevention of measles and hepatitis A, whooping cough, polio, etc. The drug is injected into the upper outer quadrant of the gluteal muscle or into the outer surface of the thigh. The medicine should not be stored in an open ampoule; it must be destroyed.

Also, you cannot use immunoglobulin in ampoules whose integrity is compromised and the markings are not visible. Under no circumstances should the intramuscular version of the drug be injected into a patient’s vein, and vice versa. Treatment and dosage are prescribed by the doctor strictly individually. Specialists take into account the type and severity of the disease, and only then make prescriptions.

Immunoglobulins are used for the manufacture of preventive vaccination compositions. There is no need to confuse them with the vaccine; they are different components.

Side effects of the drug "Normal human immunoglobulin"

When this drug is used properly, side effects are extremely rare. Sometimes these symptoms may occur several hours or even days after the medication is administered. And all side effects disappear after normal human immunoglobulin is no longer introduced into the body. 25 ml intravenously is the dose for an adult patient by drip. Sometimes the amount can reach 50 ml. Basically, the occurrence of all side factors is associated with a high rate of drug infusion. With a low rate of administration and complete cessation of immunoglobulin use, all signs of side effects decrease and disappear. During the first hour, the following conditions may appear:

1. Chills.
2. Malaise.
3. Headache.
4. Heat.
5. Aches in the joints, weakness.

In addition, some symptoms may occur:

1. cough and shortness of breath.
2. Digestive: pain in the gastrointestinal tract, diarrhea, nausea.
3. Cardiovascular system: flushing, tachycardia.
4. Central nervous system: photosensitivity, drowsiness.

Among other things, the drug "Normal Human Immunoglobulin" can cause various allergic reactions - itching, burning, skin rash. The most dangerous, but very rare phenomenon is necrosis of the renal tubules - necrosis. Severe hypertension and loss of consciousness require complete discontinuation of the drug. It is also necessary to remember that any injection of human immunoglobulin can cause allergic reactions, even if all previous injections went without complications.

Immunoglobulin during pregnancy

This medicine is used with caution during lactation, since it is known that immunoglobulin penetrates into mother's milk and can contribute to the transfer of protective antibodies to the breastfeeding baby. Normal human immunoglobulin is prescribed during pregnancy only when there is a threat of miscarriage in the expectant mother or premature birth. Sometimes the drug is prescribed when an infection occurs that threatens the life of the mother or fetus. Each question about the administration of this medicine is resolved with an individual approach and based on numerous tests. Although there is no data on the negative effects of immunoglobulin on the fetus or reproductive ability, this drug is used for pregnant women only when absolutely necessary.

Contraindications for immunoglobulin administration

Immunoglobulin preparations reduce the effect of the administration of live vaccines, such as measles, rubella, chickenpox, if they were given within 1.5-3 months. Therefore, it is very important to repeat the vaccination after using immunoglobulin. The medicine "Human Immunoglobulin Normal", the price of which ranges from 2200 to 2600 rubles, cannot be administered to patients with intolerance to blood components. It is prescribed only after consultation with doctors for heart dysfunction, diabetes, kidney disease, migraine, during pregnancy and lactation. Overdose of this medication may cause increased side effects. There is also an increase in blood viscosity and volume.

Where can I buy it?

The drug can be produced in two forms: in the form of a dry powder and a solution contained in bottles. This medicine, that is, “Normal Human Immunoglobulin,” the price of which varies greatly and depends on the manufacturer, form of release and many other factors, is purchased only in pharmacy stores. Instructions for use must be attached to it. It is prohibited to use the medicine without a doctor’s prescription, as there is a high risk of various side effects.

Storage conditions

The drug must be stored in a dry, dark place, out of reach of children, possibly even in the refrigerator. Storage temperature is 2-10 degrees Celsius. Freezing this medication is not recommended. must be indicated on the packaging. When the drug expires, it is no longer suitable for use. Before using human immunoglobulin, you should definitely consult your doctor.

Children's immunity begins to develop long before birth. Passed from mother to fetus, protective particles prepare to protect the newborn during the first months of life. In the future, the human immune system is built in the process of encountering pathogens of various diseases. If the body is unable to cope with the assigned tasks, then it can be helped through. Use is a common practice in pediatrics. Depending on the condition of the child’s body, age, and environmental conditions, the doctor selects an individual remedy. Immunoglobulin is prescribed to children in the form of injections in particularly difficult situations.

Medical statistics show that most often, products containing immunoglobulin are used by parents of children starting to attend educational institutions. When entering places with large crowds of people, the baby encounters infectious particles. It often happens that the body weakens from the colossal pressure of disease. For this reason, children are prescribed immunity tests, the results of which may become an indication for the administration of a drug that stimulates protective properties.

Release form and composition

For human immunoglobulin, there is only one dosage form - a solution. The injection method is established in accordance with the indications, age and condition of the little patient’s body. You can buy the following stimulant options at the pharmacy:

• solution for intramuscular use (dose of the drug in one ampoule 1, 1.5, 3 ml, available in packages of 5 or 10 units);
• solution for intravenous jet administration (dose of the drug in a bottle of 25 or 50 ml, available in one unit per package);
• solution for placing droppers (medicine dose 25, 50, 100 ml, available in one unit per package).

The medicinal solution contains human normal immunoglobulin. Its quantitative concentration is variable and depends on the method of administration of the drug:

• 1 ml of solution for intramuscular use contains 100 mg;
• 1 ml of the drug for intravenous jet administration includes 50 mg;
• 1 ml of intravenous solution administered by drip contains 50 mg.

You can buy immunoglobulin injections for your child only with a doctor’s prescription. The stimulant is available from pharmacies with a prescription. The medication is not suitable for independent use. Before purchasing the medicine, parents will have to contact their pediatrician, take a test, or confirm the need to use the immunomodulator for other indications.

Indications for use

Human immunoglobulin is indicated for children when their own immunity cannot cope with the initial tasks:

• recognize the causative agent of infection or a foreign organism that has penetrated from the outside;
• come into contact with detected antigens, forming a unique immune complex;
• take a direct part in the elimination of formed immune processes that the body no longer needs;
• have the ability to maintain an immune response over a certain period of time, in some cases for life.

It is impossible to visually assess that immunoglobulin should be administered when treating children. Parents can only suspect that the child’s body cannot cope with antigens. This is expressed in frequent illnesses that occur with complications, the acquisition of immunodeficiency status, frequent relapses of chronic diseases, serious allergic reactions, and changes in the performance of body systems. When studying the instructions for using human immunoglobulin, you can find out that it is prescribed according to the following indications:

• intramuscularly - with excessively low levels of immunoglobulin in the blood and plasma;
• intravenously - for severe forms of bacterial and viral infections, postoperative complications, and viral pneumonia in children;
• drip-immunodeficiency states, after organ transplantation, lymphocytic leukemia, AIDS, idiopathic thrombocytopenic purpura.

To boost the child’s immunity for prophylactic purposes, immunoglobulin is administered for autoimmune disorders and variable immunodeficiency. The medication is used in children who have low body resistance and have come into contact with dangerous infectious diseases. Administration of immunoglobulin to a newborn is indicated in cases of interaction with maternal antibodies in premature infants and a high risk of infectious diseases.

The question of the need for maintenance therapy is raised in the following cases:

• bronchial asthma;
• suspicion of thrombocytopenia in the baby;
• skin manifestations of allergic pathology;
• intolerance to many foods;
• the completion of a cold by intoxication of the body and the frequent need for treatment with antibiotics.

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Contraindications

Despite the fact that the drug is used to enhance immunity and provides benefits to the body, it has its contraindications. It is not recommended to drip, administer the solution intravenously or intramuscularly under the following conditions:

• increased sensitivity of the child to the active component;
• immunoglobulin A deficiency caused by the presence of antibodies in the body;
• exacerbation of chronic allergic reactions;
• renal failure;
• diabetes;
• the likelihood of developing anaphylactic shock due to blood products.

Before using the medication, it is important to take into account not only contraindications for use, but also the patient’s conditions in which the solution should be administered with extreme caution: recurrent migraines, heart failure. If therapy is necessary for a nursing woman, the baby should be temporarily weaned to prevent the medicine from entering his body without indications for this. For diseases caused by immunopathological processes, the solution is used only under the supervision of a physician.

Parents often have questions about the age at which immunoglobulin injections can be given. The manufacturer of the drug does not indicate any age restrictions. Injections, if indicated, are prescribed both to a child in the first days of life and at an older age. It is important to choose the appropriate dosage of the medication.

Directions for use and dosage

The instructions for use included with the drug allow immunoglobulin to be administered to children by injection in three different ways. The method of use is selected in accordance with the indications, general condition of the body, concomitant diseases, the baby’s age and medical history.

Unlike adults, children are more sensitive to various types of medical procedures. Therefore, when a stimulant is administered, children often experience an increase in body temperature. Depending on the characteristics of the child, the thermometer readings can vary from 37 to 39 degrees or more. Therefore, all injections should be done exclusively in a medical facility so that, if necessary, the little patient can receive timely, qualified assistance.

Before using the medication, it is necessary to keep the solution in the ampoule at room temperature. If it contains cloudiness and foreign impurities, then such an injection cannot be used. When giving an injection, it is important to follow the rules of asepsis.

Intramuscularly

Intramuscular administration of the drug to children is carried out in the upper thigh or buttock. Infusions with this solution are prohibited. The liquid is drawn from the ampoule with a sterile disposable syringe, the needle lumen of which is wide. This is necessary in order to avoid the formation of foam in the medicine. The dosage, administration regimen and frequency of use are determined individually for the child:

• hepatitis A - for preschool children 0.75 ml, at 10 years old 1.5 ml, for children over 3 ml (the second administration is carried out no earlier than 60 days after the previous one);
• measles – from 1.5 to 3 ml (depending on the time that has passed since contact with the infection);
• whooping cough - 3 ml twice with a break a day (no more than 3 days should pass from the moment of contact);
• meningococcal infection - 1.5 ml for infants, 3 ml for kindergarten children (no later than 7 days after contact);
• influenza – once for children under 2 years old 1.5 ml, for children of kindergarten age 3 ml, for schoolchildren up to 6 ml (in case of severe cases, the procedure can be repeated after 1 or 2 days);
• polio – from 3 to 6 ml for children who do not have artificial immunity or are not fully vaccinated;
• with reduced resistance, in order to increase immunity, the dose is calculated by weight 0.15 ml per kilogram, up to 4 injections with a break of 48-72 hours.

If blood levels indicate a decrease in immunoglobulins, the child is administered the drug in a volume equal to his body weight (1 ml per kilogram). Repeated use of the medication is permissible no earlier than after 30 days.

Immunoglobulin (Immunoglobulinum)

Compound

The active substance of the drug is the 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.

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 drug also replenishes the number of missing IgG antibodies, thereby reducing the risk of infection in individuals 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%. A gradual redistribution of the active substance of the drug occurs between the extravascular space and human plasma. Equilibrium between these environments is achieved on average within 1 week.

Indications for use

The drug is prescribed for replacement therapy if there is a need to replenish and replace natural antibodies.
Immunoglobulin is used to prevent infections in:
- agammaglobulinemia;
- bone marrow transplantation;
- primary and secondary immunodeficiency syndrome;
- chronic lymphocytic leukemia;
- variable immunodeficiency associated with agammaglobulinemia;
- AIDS in children.

The drug is also used for:
- thrombocytopenic purpura of immune origin;
- severe 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 of 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.

Mode of application

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 the state of his immune system.

Side effects

If all recommendations for administration, dosage and precautions are followed when using the drug, then the presence of serious side effects is very rare. Symptoms may appear several hours or even days after administration. Side effects almost always disappear after stopping taking Immunoglobulin. The majority of side effects are associated with the high rate of drug infusion. By reducing the speed and temporarily stopping the intake, you can achieve the disappearance of most of the effects. In other cases, symptomatic therapy is necessary.

The effects are most likely to occur when you first take the drug: during the first hour. This could 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, flushing of the face);
- central nervous system (drowsiness, weakness, rarely symptoms of aseptic meningitis - nausea, vomiting, headache, photosensitivity, impaired consciousness, stiff neck);
- kidneys (rarely acute tubular necrosis, worsening 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, 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 drug is necessary. It is also possible to administer antihistamines, adrenaline and plasma replacement solutions.

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

Pregnancy

There have been no studies on the effect of the drug on pregnant women. There is no information about the dangers of Immunoglobulin during pregnancy and lactation. But during pregnancy, this drug is administered in case of emergency, when the benefit of the drug significantly outweighs the possible risk to the child.

The drug should be used with caution during lactation: it is known that it penetrates into mother's milk and promotes the transfer of protective antibodies to the infant.

Drug interactions

The drug is pharmaceutically incompatible with other drugs. It should not be mixed with other drugs; a separate dropper should always be used for infusion. When using Immunoglobulin simultaneously with active immunization agents for viral diseases such as rubella, chicken pox, measles, and mumps, the effectiveness of treatment may decrease. If parenteral use of live viral vaccines is necessary, they can be used 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. This drug should also not be used together with calcium gluconate in infants. There are suspicions that this will lead to negative phenomena.

Overdose

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

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 drug should not be frozen. The shelf life will be indicated on the packaging. After this period, the drug cannot be used.

Synonyms

Immunoglobin, Imogam-RAJ, Intraglobin, Pentaglobin, Sandoglobin, Cytopect, Human normal immunoglobulin, Human antistaphylococcal immunoglobulin, Human tick-borne encephalitis immunoglobulin liquid, Human tetanus immunoglobulin, Venoglobulin, Imbiogam, Imbioglobulin, Human normal immunoglobulin (Immun oglobulinum Humanum Normale), Sandoglobulin, Cytotect, Humaglobin, Octagam, Intraglobin, Endobulin S/D

Active substance:

immunoglobulin

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 drug cannot be stored.

The protective effect of this drug begins to appear 24 hours after administration, its duration is 30 days. In patients prone to migraines or with impaired renal function, increased caution should 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.

Attention!
Description of the drug " Immunoglobulin"on this page is a simplified and expanded version of the official instructions for use. Before purchasing or using the drug, you should consult your doctor and read the instructions approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Immunoglobulin is an antimicrobial drug for systemic use.

Pharmacological action of Immunoglobulin

The active ingredient of the drug of the same name, immunoglobulin, is an immunologically active protein fraction that is isolated from the plasma or serum of those donors whose blood has been tested for the absence of antibodies to the hepatitis B and C virus, as well as HIV infections.

In medicine, there are several types of protein fractions, differing in the composition of amino acids, their structure and functions, namely:

• Immunoglobulin E;
• Immunoglobulin G;
• Human anti-Rhesus immunoglobulin.

Immunoglobulin E is found in small quantities in human serum, secretions and blood. Testing for its content is often necessary to detect allergic atopic diseases. The rate of Immunoglobulin E depends on the age of the person, namely (in kE/l):

• 1-3 month old children – 0-2;
• 3-6 month old children – 3-10;
• One-year-old child – 8-20;
• Five-year-old children – 10-50;
• Teenagers – 16-60;
• Adults – 20-100.

Immunoglobulin G protects the body from bacteria and infections. Analysis data for the detection of this type of protein help to identify the disease if the Immunoglobulin norm is exceeded - the human immune system is actively fighting pathological antigens.

Release form

Immunoglobulin is produced in the form of a solution for intramuscular administration, as well as in the form of a dry powder, from which a solution for infusion is prepared.

Immunoglobulin analogues

Analogues of the drug based on the main active ingredient are such drugs as:

• HyperROU S/D;
• Immunoro Kedrion;
• KamROU;
• Partobulin SDF;
• Resoclone;
• Resonant.

Analogs of anti-Rhesus Immunoglobulin, E and G, similar in their mechanism of action, and also belonging to the same pharmaceutical group, include:

• Antihep;
• Histaglobulin;
• Neohepatect;
• NeoCytotect;
• Rebinolin;
• Synagis;
• Cytotect.

Indications for use of Immunoglobulin

• For the prevention of Rh conflict in women with a negative Rh factor who do not show increased sensitivity to the Rho(D) antigen, during the first pregnancy and the birth of a child with a positive Rh factor (provided that his blood is compatible with the mother’s);
• If artificial termination of pregnancy is necessary in women with a negative Rh factor who do not show increased sensitivity to Rho(D), due to a positive Rh factor in the husband.

Mode of application

In accordance with the instructions, human anti-Rhesus immunoglobulin, E or G in the form of a solution for intramuscular administration is kept for two hours at room temperature from 18 to 22 ° C before use. It is important to draw the product into syringes using needles with a wide bore to avoid the formation of foam.

The dosage of the drug is prescribed by the doctor individually depending on the indications, age, condition and response of the patient to treatment. When calculating the dose of the drug for a patient, the doctor should pay special attention to data on deviations from the norm of immunoglobulin.

Contraindications

According to the instructions, Human Immunoglobulin is contraindicated in the following cases:

• In case of hypersensitivity to the drug;
• Women in labor whose blood serum contains Rh antibodies, as well as those who exhibit increased sensitivity to the Rh0(D) antigen;
• Newborns;
• Rh-positive women in labor.

Immunoglobulin E and G are contraindicated in cases of renal failure, anaphylactic shock, diabetes mellitus and allergies in the acute stage. Immunoglobulin is prescribed with caution in the following cases:

• For migraines and cardiac decompensated chronic failure;
• During pregnancy and lactation;
• For diseases caused by immunopathological mechanisms.

Side effects of Immunoglobulin

According to reviews, human immunoglobulin during the first day after administration can cause hyperthermia and flushing, as well as dyspepsia and a number of allergic reactions, which include anaphylactic shock.

Storage conditions for Immunoglobulin

According to the instructions, it is recommended to store the drug in a dry and dark room, at room temperature from 2 to 10 ° C. The product should not be frozen. Opened vials of Immunoglobulin G, E or human anti-Rhesus drugs cannot be stored.