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. Further the immune system The human organism 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 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 case of interaction with maternal antibodies in premature infants and high risk 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 attached to the drug allow immunoglobulin to be administered to children in the form of injections 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 top part thighs or buttocks. Infusions with this solution are prohibited. The liquid from the ampoule is drawn with a sterile disposable syringe, whose needle lumen 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 - children preschool age 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.

ABOUTmain properties

The drug is an immunologically active protein fraction isolated from the blood plasma of donors examined for the absence of hepatitis B virus surface antigen (HBsAg), antibodies to the human immunodeficiency virus (HIV-1, HIV-2), antibodies to the hepatitis C virus, purified and concentrated by the fractionation with alcohol-water precipitants, and also went through the stage of viral inactivation using the solvent-detergent method.

Transparent or slightly opalescent, colorless or yellowish liquid. During storage, a slight sediment may appear, which disappears with shaking. The drug does not contain preservatives or antibiotics.

Qualitative and quantitative composition

1 ml of the drug contains:

active substance - immunoglobulins G - 100 mg;

Excipients - sodium chloride;

Excipients - glycine (glycocol, aminoacetic acid).

1 ampoule of 1.5 ml contains 150 mg of immunoglobulin G.

Distribution of IgG by subclasses: no data.

Pharmacotherapeutic group

Immunoglobulins.

ATC code: J06B A01.

Immunological and biological properties. The drug increases the body's nonspecific resistance. The active basis is immunoglobulins - antibodies of different specificities, the concentration of which in the blood when the drug is administered reaches a maximum after 24 hours. The half-life of antibodies from the body is 4-5 weeks. The drug contains from 9 to 11% protein.

Indications for use

1. Prevention of measles. Normal human immunoglobulin - Biopharma can prevent or modify measles in susceptible individuals (not vaccinated and not previously had measles) in contact with sick people

2. TreatmenthypO- Andagammaglobulinemia. For the purpose of replacement therapy for hypo- and agammaglobulinemia, the use of normal human immunoglobulin preparations for intramuscular administration is permitted only in exceptional cases when normal human immunoglobulin preparations for intravenous or subcutaneous administration are not available or cannot be used.

Directions for use and doses

Normal human immunoglobulin is administered exclusively intramuscularly.

Prevention of measles: the drug is prescribed once.

For children over 3 months of age who have not had measles, when no more than 6 days have passed from the moment of contact, the drug is administered at the rate of 0.25 ml/kg body weight for the intramuscular route of administration. In immunocompromised patients, the dose may be increased to 0.5 ml/kg body weight. The maximum dose of 15 ml should not be exceeded.

TreatmenthypO- Andagammaglobulinemia: in exceptional cases, when the drug can be used for subcutaneous or intravenous administration, low doses of normal human immunoglobulin - Biopharma can be administered intramuscularly. The intramuscular injection must be given by a doctor or nurse. Dose - 100-150 mg/kg (0.6-0.9 ml/kg). The drug cannot be used intramuscularly in cases of severe thrombocytopenia and other hemostasis disorders.

Side effects

As a rule, there are no reactions to the administration of immunoglobulin.

Often

Reactions at the injection site may occur: pain and sensitivity.

Rarely

Hypersensitivity; hypotension.

Very rarely:

Fever, chills, fatigue; artlargia, back pain; nausea, vomiting; headache, dizziness; anaphylactic shock.

In case of shock, use standard treatment. In this regard, patients should be under medical supervision for 30 minutes after administration of the drug.

Contraindications

Severe allergic reactions to the administration of human blood protein products.

Severe thrombocytopenia and other hemostatic disorders - the risk of bleeding and hemorrhage at the injection site.

Ig A deficiency, in patients with antibodies to Ig A.

Special warnings and precautions

Direct injection of immunoglobulin into a blood vessel can cause shock.

The patient should be monitored for adverse reactions throughout the entire administration procedure and for at least 20 minutes after its completion.

Some side effects occur more often in patients receiving normal human immunoglobulin for the first time and less often in patients switched to this drug, as well as in patients after a break in treatment of more than 8 weeks.

Hypersensitivity reactions are rare and may occur in patients with IgA deficiency with the presence of anti-IgA antibodies. The drug should be prescribed to these patients with caution.

In rare cases, administration of immunoglobulin may cause a fall blood pressure with the development of an anaphylactic reaction. This complication can occur even in patients who were previously tolerant to normal human immunoglobulin. The following actions can help avoid the development of potential complications.

Make sure that:

The patient does not suffer from hypersensitivity to normal human immunoglobulin (introduce the product at a low speed for the first time);

The patient is monitored for symptoms of complications throughout the administration. In particular, this applies to patients receiving normal human immunoglobulin for the first time and patients who are transferred from alternative methods treatment, patients after a long break in treatment - such patients should be monitored during the entire period of the first injection and one hour after. Other patients should be observed for 20 minutes after drug administration.

If you suspect symptoms of adverse reactions, you should immediately stop administering the drug. If signs of shock appear, antishock therapy should be resorted to.

To control the quality of the drug, it is strongly recommended to record the name and series of the drug Normal Human Immunoglobulin - Biopharma when used in each patient - this will allow us to identify the connection between each patient and a particular series of the drug.

The drug Normal human immunoglobulin - Biopharma does not protect against hepatitis A. Normal human immunoglobulin is used with caution in renal failure: a transient increase in creatinine levels has been reported after administration of immunoglobulin to several patients with impaired renal function (in patients with diabetes mellitus and lupus erythematosus). In such patients, serum creatinine levels should be monitored for three days after administration.

There are no data on the use of the drug in elderly people.

Features of application

Intravenous administration of the drug is prohibited! After the expiration date, the use of the drug is unacceptable.

Use during pregnancy and lactation

It is not recommended to use the drug during pregnancy and lactation. For patients who have a history of allergic diseases not associated with the administration of protein preparations from donor blood, antihistamines are recommended on the day of immunoglobulin administration and for the next 3 days. For persons who suffer from immunopathological systemic diseases (diseases of the blood, connective tissue, nephritis, etc.), immunoglobulin is administered against the background of appropriate therapy.

Incompatibility

Incompatible with other medications in the same syringe. It is permissible to mix only with 0.9% sodium chloride solution.

Interaction with other drugs

In complex therapy, it is compatible with other groups of drugs. Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chickenpox (when administered in the first two weeks after vaccination against measles, mumps and rubella, vaccinations with these vaccines should be repeated no earlier than 3 months later). For measles, this period can last up to 1 year, so it is necessary to check the antibody titer before immunization. If it is necessary to use immunoglobulin earlier than this period, vaccination against measles or mumps must be repeated. Vaccinations against other infections can be carried out at any time before or after the administration of immunoglobulin. A temporary increase in the level of antibodies in the patient's blood after the administration of immunoglobulin may be the cause of false-positive serological tests. The drug should be mixed only with 0.9% sodium chloride solution. Other drugs cannot be added to the solution, since changes in electrolyte concentration or pH value can cause protein denaturation.

Dosage form:  solution for intramuscular administration Compound: Immunoglobulin, aminoacetic acid (glycine), sodium chloride, water for injection. Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow. A slight sediment may appear, which disappears when shaken.

Pharmacotherapeutic group: MIBP - ATX globulin:  

J.06.B.A.02 Normal human immunoglobulin for intravenous administration

Pharmacodynamics:

The drug is an immunologically active protein fraction containing a wide range of antibodies, isolated from human plasma or serum of donors tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and hepatitis B virus surface antigen. Active a component of the drug are immunoglobulins, which have antibody activity of various specificities.

Pharmacokinetics:

The maximum concentration of antibodies in the blood is reached after 24 hours; the half-life of antibodies from the body is 4-5 weeks. The drug also increases the body's nonspecific resistance.

Indications:

The drug is used only as prescribed by a doctor for the prevention of hepatitis A, measles, influenza, whooping cough, meningococcal infection, polio, treatment of hypoagammaglobulinemia, to increase the body's resistance during the period of convalescence of infectious diseases.

Contraindications:

The administration of immunoglobulin is contraindicated in persons with a history of allergic reactions or severe systemic reactions to human blood products.

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

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

Carefully:

Severe heart failure, diabetes mellitus, renal failure, pregnancy, lactation.

Pregnancy and lactation:During pregnancy, it is administered only according to strict indications, when the expected benefit to the mother outweighs the potential risk to the fetus.

Immunoglobulin penetrates into breast milk and may facilitate the transfer of protective antibodies to the newborn.

Directions for use and dosage:

Immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteal muscle or the outer surface of the thigh. The drug should not be administered intravenously.

Before the injection, ampoules with the drug are kept for 2 hours at room temperature (20+2)°C. 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 dose of the drug 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; up to 10 years - 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.

Preventing measles

The drug is administered once from the age of 3 months to those who have not had measles and who have not been vaccinated against the infection no later than 6 days after contact with the patient. The dose of the drug for children (1.5 or 3.0 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 3.0 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 - 3.0 ml; over 7 years old and adults - 4.5-6.0 ml. When treating severe forms of influenza, repeated (after 24-48 hours) administration of immunoglobulin in the same dose is indicated.

Prevention of whooping cough

The drug is administered twice with an interval of 24 hours in a single dose of 3.0 ml to children who have not had whooping cough, as often as possible early dates contact with the patient.

Prevention of meningococcal infection

The drug is administered in single doses 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 for children under 3 years of age and 3.0 ml for children over 3 years of age.

Prevention of polio

The drug is administered once in doses of 3.0-6.0 ml to unvaccinated or incompletely vaccinated children with polio vaccine as early as possible after contact with a patient with the paralytic form of polio.

Treatment of hypo- and agamoglobulinemia

The drug is administered at a dose of 1.0 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 one month.

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

The drug is administered in a single dose of 0.15-0.2 ml per 1 kg of body weight. The frequency of administration (up to 4 injections) is determined by the doctor; the intervals between injections are 2-3 days.

Side effects:

In rare cases, reactions may develop in the form of hyperemia and an increase in temperature to 37.5 ° C during the first day after administration, as well as dyspeptic symptoms.

Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock.

Headache, dizziness, migraine pain, nausea, vomiting, abdominal pain, diarrhea, arterial hypo- or hypertension, tachycardia, cyanosis, chills, shortness of breath, feeling of constriction or pain in the chest, allergic reactions.

Interaction:

The introduction of immunoglobulins can weaken (for 1.5-3 months) the effect of live vaccines against such viral diseases, such as measles, rubella, mumps and chicken pox (vaccinations with these vaccines should be repeated no earlier than after 3 months). After the administration of large doses of immunoglobulin, its effect can last in some cases up to one year.

A temporary increase in the content of injected antibodies in the patient’s blood after the administration of immunoglobulin can cause false-positive results of serological tests.

Do not use simultaneously with calcium gluconate in infants.

Special instructions:

Administration of immunoglobulin and preventive vaccinations. Treatment with immunoglobulin preparations reduces the effectiveness of vaccination, so vaccinations are carried out no earlier than 2-3 months after the administration of immunoglobulin.

Persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions on the day of immunoglobulin administration and for the next 8 days, it is recommended to prescribe antihistamines. During the period of exacerbation of the allergic process, the drug is administered according to the conclusion of an allergist.

For persons suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis, etc.), the drug should be administered against the background of appropriate therapy.

A temporary increase in antibodies in the blood after administration leads to false-positive test data in a serological test (Coombs reaction).

Immunoglobulins for intramuscular administration are strictly prohibited from being administered intravenously. After administration of the drug, the patient's condition should be monitored for at least 30 minutes. Antishock therapy must be available in the room where the drug is administered. When anaphylactoid reactions develop, antihistamines, glucocorticosteroids and adrenergic agonists are used.

Name: Immunoglobulin (Immunoglobulinum)

Pharmacological effects:
The drug is considered an immunomodulatory and immunostimulating agent. Contains a large number of neutralizing and opsonizing antibodies, thanks to which it is well resistant to viruses, bacteria and other pathogens. The drug also replenishes the number of missing IgG antibodies, thereby reducing the risk of infection in people with primary and secondary immunodeficiency. Immunoglobulin well 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 drug between the extravascular space and human plasma. Equilibrium between these environments is achieved on average within 1 week.

Immunoglobulin - 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 when:
- 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 (mainly 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.

Immunoglobulin - method 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.

Immunoglobulin - side effects:

If all recommendations for administration, dosage and precautions are followed when using the medicine, then the presence of serious side effects is very rare. Symptoms are likely to 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 speed of drug infusion. By reducing the speed and temporarily stopping the intake, it is possible to achieve the disappearance of the bulk of the effects. In other cases, symptomatic therapy should be carried out.

Effects are most likely to occur when you first take the medicine: within the first hour. This may be a flu-like syndrome - malaise, chills, heat body, 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 data severe cases discontinuation of the medication is necessary. Administration of antihistamines, epinephrine, and plasma replacement solutions is also likely.

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 drug 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 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.

Immunoglobulin - 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. However, during pregnancy, this drug is administered in case of emergency, when the benefit of the drug significantly exceeds possible risk for a 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.

Interaction with other drugs:
The drug is considered pharmaceutically incompatible with other drugs. It should not be mixed with other medications; you should always use a separate dropper 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 dosage of Immunoglobulin is administered, its effects can last for a year. It is also prohibited to use this drug together with calcium gluconate in infants. There are suspicions that this will lead to negative phenomena.

Immunoglobulin - 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.

Immunoglobulin - release form:

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

Immunoglobulin - storage conditions:

The drug should 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.

Immunoglobulin - 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 (Immunoglo bulinum Humanum Normale), Sandoglobulin, Cytotect, Humaglobin, Octagam, Intraglobin, Endobulin S/D

Immunoglobulin - composition:

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.

Immunoglobulin - additionally:

The drug should be used only as prescribed by a doctor. It is prohibited to 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 urgently, since the already dissolved drug cannot be stored.

The protective effect of this medicine 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.

It is strictly forbidden to administer Immunoglobulin intravenously for intramuscular use. It is forbidden to exceed the rate of intravenous administration; this threatens the development of collaptoid reactions.

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

Important!
Before using the medicine Immunoglobulin you should consult your doctor. This instruction is intended for informational purposes only.

The protein fraction isolated from blood plasma - Human Immunoglobulin - is a medicine that helps increase the body's resistance to infections. Has a pronounced anti-inflammatory effect.

Release form and composition

Human immunoglobulin is an injection solution available in two forms - for intramuscular and intravenous administration.

Indications for use

According to the instructions, Human immunoglobulin in the form of a solution intended for intramuscular administration is used as a means of emergency prevention of infections such as:

• Meningococcal;
• Hepatitis A;
• Whooping cough;
• Measles;
• Polio.

Indications for intravenous administration of Human Immunoglobulin:

• Severe forms of infections, including sepsis;
• Chronic lymphocytic leukemia;
• Primary immunodeficiency;
• Thrombocytopenic purpura;
• Multiple sclerosis;
• Kawasaki disease;
• HIV infection;
• Dermatomyositis.

Contraindications

The use of Human Immunoglobulin is limited by the following contraindications:

• History of hypersensitivity reactions to injections of blood products;
• Maltose and sucrose intolerance;
• IgA immunodeficiency.

Human immunoglobulin should be used with caution in diseases and conditions such as:

• Chronic cardiac failure in the stage of decompensation;
• Diabetes;
• Severe renal impairment;
• Pregnancy;
• Lactation period.

In case of sepsis development, only anaphylactic shock caused by previous administration of blood products is considered a contraindication to the use of Human Immunoglobulin.

Directions for use and dosage

According to the attached instructions, Human immunoglobulin is administered intramuscularly for prophylactic purposes.

Dosage depending on the patient’s age and type of infection:

• Measles. The drug is administered once, for children from 3 months - 1.5-3 ml, for adults - 3 ml. If more than 4 days have passed after contact with the patient, the injection is not given, since the preventive effect of it is sharply reduced;
• Polio. Unvaccinated or not received full course vaccination, children are given a single dose of 3-6 ml of immunoglobulin immediately after contact with a person affected by the paralytic form of the infectious disease is detected;
• Hepatitis A. Children from 1 year to 10 years are prescribed 0.75-1.5 ml of solution, over 10 years and adults - 3 ml, if indicated, after 2 months Human immunoglobulin is re-administered in the same age-specific doses;
• Flu. The drug is prescribed as both prophylactic and remedy, children under 7 years old - 1.5-3 ml of the drug, over 7 years old and adults - 4.5-6 ml. In case of severe disease, repeated administration is indicated after 1-2 days;
• Whooping cough. Unvaccinated children or those who have not received the full course of vaccination are administered 3 ml of solution twice with an interval of 1 day;
• Meningococcal infection. Immunoglobulin is indicated for use if no more than 7 days have passed after contact with a person suffering from a generalized form of the disease. The amount of solution administered to children from 6 months to 3 years is 1 ml, to patients over 3 years old - 3 ml.

Human immunoglobulin, used as a therapeutic agent, is administered intravenously.

In pediatric practice medicinal product pre-dilute with dextrose or physiological solution. The pediatric dosage of immunoglobulin is 3-4 ml/kg, but not more than 25 ml. The procedures are carried out once a day for 3-5 days, the recommended rate of administration of the drug is 8-10 drops per minute.

For adult patients, the intravenous solution is used undiluted in 25-50 ml, at a rate of up to 40 drops per minute. A total of 3 to 10 drip infusions are prescribed per course, performed at intervals of 1-3 days.

Side effects

TO side effects caused by the use of Human Immunoglobulin include:

• Hypersensitivity reactions, including anaphylactic shock, redness of the skin at the injection site, low-grade fever;
• Dizziness, headache;
• Dyspeptic disorders, abdominal pain;
• Significant decrease in pressure, tachycardia, collapse, chills, loss of consciousness.

special instructions

After the administration of Human Immunoglobulin, a medical withdrawal of up to 2-3 months from routine vaccinations is indicated, since the drug significantly reduces the effectiveness of the vaccination.

If there are concomitant diseases of an allergic nature or a tendency to hypersensitivity reactions, the solution is administered to the patient only against the background of antihistamine therapy.

Human immunoglobulin passes into mother's milk and can contribute to the transfer of protective antibodies to the newborn.

After administering the medicinal solution, the patient’s condition should be monitored for 30 minutes so that if a shock develops, the necessary medical care can be provided to the patient in a timely manner.

When administering intravenous infusions of Human Immunoglobulin, it is recommended to follow the instructions on the optimal rate of administration of the drug, exceeding which can provoke the development of collapse.

Analogs

Synonyms for Human Immunoglobulin are the following drugs:

• Gabriglobin;
• Gamimun N;
• Gamunex;
• Imbioglobulin;
• Immunovenin;
• Intraglobin;
• Intratect;
• Octagam;
• Privigen;
• Phlebogamma.

Similar pharmacological action have the drugs Histaseroglobulin and Pentaglobin.

Terms and conditions of storage

According to the information specified in the instructions, Human immunoglobulin must be stored at a temperature of 2 ° C to 8 ° C in a dry place, protected from exposure to light.

The shelf life of the solution is 1 year.