Immunoglobulin dropper indications. Human immunoglobulin is normal, solution for intravenous administration. How is intravenous immunoglobulin administered?

Human immunoglobulin is normal: instructions for use and reviews

Latin name: Immunoglobulinum humanum normale

ATX code: J06BA02

Active substance: immunoglobulin human normal

Producer: NPO FGUP MZ RF "Microgen" (Russia)

Description and photo update: 13.08.2019

Normal human immunoglobulin is an immunological agent.

Release form and composition

Dosage forms of normal human immunoglobulin:

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

The active substance is normal human immunoglobulin:

Solution for intramuscular injection: in 1 ml - 100 mg;
Solution for intravenous administration: in 1 ml - 50 mg;
Solution for infusion: 1 ml - 50 mg.

Pharmacological properties

Pharmacodynamics

Normal human immunoglobulin contains approximately 90% of monomeric IgG and a small amount of degradation products fraction, dimeric and polymeric IgG and IgA, as well as IgM in trace concentrations. IgG subclasses are fractionated 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 replenishes 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 the equilibrium state is reached in about 7 days.

The substance crosses the placental and blood-brain barriers, and is also determined 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 shown:

Solution for intramuscular injection: for the treatment of agamma and hypoglobulinemia; for the prevention of: whooping cough, measles, hepatitis A, meningococcal infection, influenza, poliomyelitis; to increase the body's resistance to infectious diseases during the period of convalescence;
Solution for intravenous administration: therapy of severe forms of viral and bacterial infections; with 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, immunodeficiency congenital conditions (partial, complete or variable immunodeficiency, severe forms of combined immunodeficiency, Wiskott-Aldrich syndrome), as well as acquired immunodeficiency as a result of bone marrow transplantation and other types of transplantation, with chronic lymphocytic leukemia, with AIDS in children, Kawasaki syndrome (as 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 allergic reactions (patients of this category may be administered the drug with the simultaneous use of antihistamines, which continue to be administered for 3 days with i / m and 8 with / in the introduction of immunoglobulin);
Systemic immunopathological diseases, including nephritis, blood diseases, connective tissue(if it is necessary to use immunoglobulin, the introduction should be made only after consultation with the appropriate specialist and against the background of the appointment of concomitant therapy).

Do not use a solution for intramuscular administration in infants at the same time as calcium gluconate.

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

Care should be taken to prescribe a solution for infusion during pregnancy and breastfeeding.

Instructions for use of normal human immunoglobulin: method and dosage

The solution for intramuscular injections is injected into the outer surface of the thigh or the upper outer quadrant of the gluteus muscle (intravenous administration of the drug is prohibited!) Do not store the drug in an opened ampoule, use ampoules with broken labeling or tightness, if the color of the solution changes, it becomes cloudy or the presence of unbreakable flakes, if the storage conditions are violated and the expiration date has expired. Within 2 hours before administration, ampoules with the drug should be kept at room temperature. The procedure is carried out in compliance with the rules of antisepsis 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 administration of immunoglobulin are prescribed by the doctor based on clinical indications.

Hepatitis A: once, for children from 1 to 6 years old at a dose of 0.75 ml, up to 10 years old - 1.5 ml, for 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 that has passed 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, for adults - 3 ml (shown to patients from the age of 3 months, not sick with measles and not vaccinated against it, no later than 6 days from the moment of contact with the patient);
Prevention of whooping cough: children who are not sick and not vaccinated or not fully vaccinated against whooping cough - 3 ml twice with a break of 24 hours for the shortest time, but not 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 at 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, children incompletely or not vaccinated with poliomyelitis vaccine, more early dates after contact with a polio patient;
For the treatment and prevention of influenza, the solution is administered once: children under 2 years old at a dose of 1.5 ml, from 2 to 7 years old - 3 ml, patients over 7 years old - 4.5-6 ml -48 hours) administration of a dose of the drug;
In the treatment of agamma and hypoglobulinemia, the appointment is made in a dose of 1 ml per 1 kg of the patient's weight (it can be administered in 2-3 doses with a break of 24 hours). Carrying out subsequent prescriptions of the drug according to indications is possible only after 1 month;
To increase the body's resistance in chronic pneumonia and during the period of convalescence with a protracted course of acute infectious diseases, the introduction of a single dose of 0.15-0.2 ml per 1 kg of the patient's 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% sodium chloride solution with isotonic or 5% glucose solution in a ratio of 1: 4. A ready-made solution of immunoglobulin is injected intravenously at a rate of 8-10 drops per minute, daily for 3-5 days. Without additional dilution, immunoglobulin can be injected intravenously at a rate of 30-40 drops per minute, the course of treatment is 3-10 transfusions, carried out with an interval of 24-72 hours. This method of administration can cause the patient to collapse. Transfusion treatment can be combined 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 stationary conditions in compliance with the rules of asepsis. Before the introduction, it is necessary to keep the bottles with the drug for 2 hours at room temperature. Solutions containing sediment or cloudy should not be used.

The solution for infusion is administered by intravenous drip, it is recommended to warm the drug to body temperature or room temperature before use. You can enter only a clear solution. 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 1 time per month until the level of immunoglobulin increases or increase the dose to 16 ml per 1 kg of body weight);
With allogeneic bone marrow transplantation, the patient is prescribed 10 ml per 1 kg of body weight for 7 days;
With Kawasaki syndrome - 32-40 ml per 1 kg of body weight for 2-5 days, or 40 ml per 1 kg - once;
With idiopathic thrombocytopenic purpura - 16-20 ml per 1 kg of body weight, once (if necessary, it can be repeated after 2-3 days), or 8 ml per 1 kg of patient's 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 body weight, daily for 1 to 4 days;
For premature babies (with low birth weight), for the prevention of infections, the administration of the drug is prescribed with a break of 1-2 weeks, 10-20 ml per 1 kg of the infant's weight;
For chronic inflammatory demyelinating neuropathy, Guillain-Barré syndrome: 8 ml per 1 kg of body weight for 5 days (the course may be repeated with an interval of 4 weeks);
Patients with cerebral ischemia and ischemic disease hearts: 8 ml per 1 kg, daily.

Side effects

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

In some cases, the development of allergic reactions is possible. different types up to anaphylactic shock. Therefore, after administration of the drug, patients should be under the supervision of medical personnel for 30 minutes; the room where the drug is administered must be provided with anti-shock therapy means.

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

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

Overdose

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

special instructions

Normal human immunoglobulin should be used only as directed by a physician.

Each procedure is registered in the established registration 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 drug administration.

After the introduction 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, the vaccination should be repeated. All other vaccinations are allowed at any time, regardless of the time of drug administration.

Normal human immunoglobulin can cause false positive serological test results.

Drug interactions

A clinically significant drug interaction of a solution for intramuscular or intravenous administration has not been established.

Solution for infusion reduces the activity of attenuated live vaccines against rubella, measles, chickenpox, mumps. If it is necessary to administer immunoglobulin during the first 2 weeks after vaccination against mumps, measles or rubella, the vaccination against these diseases must be repeated after 3 months. The infusion solution 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 out of the reach of children.

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

Human immunoglobulin contains the main active component - the immunoglobulin fraction. Initially, it is released from human plasma, and then it is purified and concentrated. The drug does not contain antibodies to human immunodeficiency viruses and hepatitis C. Also, antibiotics are not present in its composition. The protein concentration level reaches 5.5%. The drug has low anti-complementary activity. It is an immunological agent.

Pharmacological forms

Immunoglobulin-based medicines are produced by the manufacturer in two pharmacological forms... This is a solution intended for intramuscular administration, and a powder from which a solution intended for intravenous infusion is prepared. The solution is a clear or slightly opalescent liquid.

Pharmacological effects

Human immunoglobulin is capable of having an immunomodulatory and immunostimulating effect. It contains a large amount of neutralizing and opsonizing antibodies. Thanks to them, an effective resistance to various bacteria and viruses is ensured.

Against the background of the action of this agent, the amount of deficient IgG antibodies is replenished. As a result, the likelihood of developing infectious diseases in patients with primary or secondary immunodeficiency decreases. Immunoglobulin is able to replace and replenish natural antibodies in the blood serum.

Pharmacodynamics and pharmacokinetics

The bioavailability of the active substance with intravenous infusion reaches 100%. Over the next 14 days, the highest saturation of antibodies is noted in human blood. The drug is excreted for up to 5 weeks. The drug is able to penetrate the placenta and enter breast milk.

Indications for use

Normal human immunoglobulin is used when carrying out substitution therapy if the patient requires treatment aimed at replenishing and replacing natural antibodies.

The drug can be used for prophylactic purposes in case of:

The need to prevent diseases of infectious etymology in newborns born prematurely.
The need to prevent miscarriage.
Hemophilia, which was triggered by the synthesis of antibodies to factor P.
Thrombocytopenia and hemolytic anemia, the origin of which is autoimmune.
Chronic demyelinating polyneuropathy.
Neutropenia of autoimmune origin.
Erythrocyte aplasia.
Guillain-Barré syndrome.
Kawasaki Syndrome.
Infections of viral and bacterial etymology with a severe course.
Thrombocytopenic purpura of immune origin.
AIDS in childhood.
Chronic lymphocytic leukemia.
Variable immunodeficiency.
Primary as well as secondary immunodeficiency.
Agammaglobulinemia.
The need for bone marrow transplantation.

This is confirmed by the instructions for use for human immunoglobulin.

Contraindications to use

This medicine should not be used if the patient has:

Anaphylactic reaction to blood products.
Diabetes.
Lack of kidney functionality.
Hypersensitivity to human immunoglobulins.
Acute forms of allergic reactions.
IgA deficiency in the presence of antibodies to it.

When prescribing therapy using human normal immunoglobulin, it is important to take into account not only the presence of contraindications, but also conditions and diseases for which treatment should be carried out with caution.

The drug should be prescribed under close supervision to patients suffering from migraines, decompensated heart failure in chronic form, pregnant women, women who are breastfeeding. Caution should be exercised when using immunoglobulins for immune blood diseases, nephritis, collagenosis and other diseases associated with immunopathological mechanisms.

Side effects

When using human immunoglobulin with strict adherence to the instructions, side effects are rare. However, it is important to take into account that the development of undesirable effects can occur several hours, days after the drug was administered to the patient. Most often, all side effects completely disappear after stopping immunoglobulin therapy.

The main reason for developing negative impacts, - high speed of drug administration. Reducing the rate of introduction or suspension of its introduction allows you to get rid of negative factors. If they do not disappear, then it is recommended to stop therapy completely.

Side effects from injections of human immunoglobulin are most often observed with the first administration. The symptoms are as follows:

Local skin reactions.
Allergic reactions.
Aseptic meningitis, impaired consciousness, photosensitivity, drowsiness and weakness.
Chest pains, hot flashes, cyanosis, tachycardia.
Stomach pain, increased saliva production, diarrhea, vomiting.
Shortness of breath, dry cough.
Flu-like syndrome: body temperature rises, chills, weakness develop, headaches occur.

In addition, the patient may feel aching joints, back pain, hiccups, sweating, myalgia. In rare cases, loss of consciousness, severe hypertension, collapse may occur. In case of a serious reaction to therapy with this drug, its use should be discontinued. If necessary, the patient is injected with plasma replacement solutions, adrenaline, and antihistamines are provided.

Dosage and administration

According to the instructions for use, human immunoglobulin can be used for intramuscular administration or intravenous infusion. The dosage should be selected by the physician based on the severity of the disease and the patient's immunity.

Children are shown the introduction of 3-4 ml of solution for each kilogram of body weight. The total dosage cannot be more than 25 ml. Human immunoglobulin, before being administered, should be diluted with sterile sodium chloride (0.9%) or glucose solution (5%) in a ratio of 1: 4. The introduction is carried out intravenously, and the rate of administration should not exceed 10 drops per minute. The duration of the course of infusion is up to 5 days. For children, human immunoglobulin should be used with particular caution, since there is a high risk of developing allergies.

Adults are shown to use a dosage of 25-50 ml per application. Additional dilution of the drug is not required. The infusion is carried out intravenously, and the infusion rate should not exceed 40 drops per minute. The duration of the course of therapy can be from 3 to 10 infusions, which should be carried out once a day or every three days.

Before the introduction, it is imperative to keep the solution at room temperature for up to 2 hours. If a precipitate appears or the solution becomes cloudy, it is necessary to abandon its use.

Prevention of various ailments

The medication is also used for preventive purposes:

With hepatitis A: at the age of 1-6 years - 0.75 ml, up to 10 years - 1.5 ml, from 10 years and older - 3 ml once.
For the prevention of meningitis: 6 months-3 years - 1.5 ml, 3-7 years - 3 ml once.
For the prevention of whooping cough: 3 ml twice, at least 24 hours should pass between doses, but no later than three days from the moment of contact with the patient.
For the prevention of measles: 1.5-3 ml once.
The solution is administered once for the flu and for its prevention: up to 2 years - 1.5 ml, from 2-7 years - 3 ml, from 7 years - 4.5-6 ml.
For the prevention of poliomyelitis: 3-6 ml once.

Overdose

Human immunoglobulin intramuscularly is usually well tolerated. With intravenous administration of the medication, the occurrence of symptoms of an overdose is possible. They are expressed in hypervolemia and increased blood viscosity. Most often, an overdose is manifested in elderly patients and in those who suffer from kidney disease.

Interaction with other medications

Pharmaceutical drug is incompatible with any other medications. Mixing it with other products is strictly prohibited.

The effectiveness of immunoglobulin is reduced if it is used in conjunction with immunizing drugs against measles, chickenpox and rubella.

Parenteral administration of live viral vaccines should be carried out at least one month after completion of immunoglobulin therapy. The optimal break is three months.

The simultaneous use of the drug in infants with calcium gluconate is prohibited.

Does human immunoglobulin have analogs for intravenous administration, as well as for intramuscular administration?

Analogs

Currently, there are a number of drugs similar in their action. These include: "Endobulin", "Gabriglobin", "Intratect", "Pentaglobin", "Intraglobin", "Immunovenin", "Gamunex".

The selection of an analogue should be carried out in conjunction with a doctor.

Also, analogues of the drug include:

"Immunovenin";
"Intratect";
"Immunoglobulin Sigardis";
"Wigham-S";
"Gabriglobin - IgG";
"Venoglobulin";
"Gamimun N".

All of them have the same composition of active ingredients, with the same therapeutic effect.

This group of funds is dispensed only with a doctor's prescription. The doctor chooses an individual dosage for each patient.

The cost of the drug

The cost of the drug intended for intramuscular administration is on average 900 rubles per package containing 10 ampoules. The average cost of a drug intended for intravenous infusion will be about 2600 rubles per 25 ml bottle.

Or gamma globulins are special proteins distributed in 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 "Human immunoglobulin normal"

Human immunoglobulin is a drug composition based on blood components of healthy donors - plasma. Donors should be clinically evaluated. The blood donated by them must undergo laboratory testing. It will show that this material has no signs of infectious diseases that can be transmitted by and 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. By its properties, the drug "Normal human immunoglobulin" practically does not differ from the type G, which is present in tissue fluids, in secretions produced by human mucous membranes, etc. This all-round protection of the body, which has the name - It performs 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 tonic and anti-inflammatory effect.

In what cases of diseases is immunoglobulin prescribed?

This medication is prescribed to replace or replenish natural human antibodies. The main indications for its introduction are various states of the human body, when its own defense is extremely weakened. Such pathologies include:

Bone marrow transplantation.
Primary and secondary immunodeficiencies.
Severe viral and bacterial diseases and etc.

The drug "Human immunoglobulin normal" has a positive effect. Reviews about him are numerous and contradictory for a variety of infections, inflammatory and chronic diseases. In addition, this drug helps to increase the suppressed immunity under the influence of the drugs taken.

Intravenous immunoglobulin use

Injections of a drug that increases immunity can be done both intramuscularly and intravenously. It is prescribed for various complications after operations accompanied by sepsis, multiple sclerosis, as well as for prophylactic actions and treatment of infectious complications in newborns, etc. It is in these cases that the drug "Normal human immunoglobulin" is administered. The intravenous method of drug administration in these cases is the most effective. Instructions for use of the drug describe the basic principles by which the treatment is carried out directly, prescribed by the attending physician, taking into account all indications, the severity of the disease, the condition immune system patient and individual intolerance. To administer the medication, you need a dropper and saline solution. The concentration of human immunoglobulin can be from 3 to 12 percent.

Intramuscular injection of immunoglobulin

Ampoules before use should be kept at room temperature for 2 hours. Their opening and direct administration of the drug should be carried out with strict adherence to the rules of antiseptics.

There are other ways how to administer the drug "Immunoglobulin normal" to a patient. A person can be injected intramuscularly with this drug for emergency prevention of measles and hepatitis A, whooping cough, poliomyelitis, etc. The drug is injected into the upper outer square of the gluteus muscle or into the outer surface of the thigh. The medicine is not stored in an open ampoule, it must be destroyed.

Also, you can not use immunoglobulin in ampoules, in which the integrity is broken and the marking is not visible. In no case should an 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. Experts take into account the type and severity of the disease, only after that they make appointments.

Immunoglobulins are used to make preventive vaccine formulations. There is no need to confuse them with the vaccine, these are different components.

Side effects of the drug "Human immunoglobulin normal"

Side effects are extremely rare with proper use of this drug. Sometimes, these symptoms may appear several hours or even days after the medication is given. And all the side effects disappear after the normal human immunoglobulin ceases to be introduced into the body. 25 ml intravenous - the dose of an adult patient by drip method. Sometimes the amount can reach 50 ml. Basically, the occurrence of all side factors is associated with the high rate of infusion of the medication. At a low rate of administration and with a complete cessation of the use of immunoglobulin, all signs of side effects decrease and disappear. During the first hour, the following conditions may appear:

Chills.
Malaise.
Headache.
Heat.
Joint aches, weakness.

In addition, there may be some symptoms from the side:

cough and shortness of breath.
Digestive: pain in gastrointestinal tract, diarrhea, nausea.
Cardiovascular system: flushed face, tachycardia.
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 - necrosis of the renal tubules - necrosis. Severe hypertension and loss of consciousness require complete withdrawal of the drug. It must also be remembered that any injection of human immunoglobulin can cause allergic reactions, even if all previous injections have passed without complications.

Immunoglobulin during pregnancy

This medication is used with caution during lactation, since it is known that immunoglobulin penetrates into breast milk and can contribute to the transfer of protective antibodies to the infant. Normal human immunoglobulin is prescribed during pregnancy only with the 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 introduction of this medication is solved with an individual approach and on the basis of numerous analyzes. Although there is no evidence of a negative effect of immunoglobulin on the fetus or reproductive capacity, this drug is used in pregnant women only if absolutely necessary.

Contraindications for the administration of immunoglobulin

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 the immunoglobulin. The medicine "Normal human immunoglobulin", the price of which ranges from 2,200 to 2,600 rubles, cannot be administered to patients with intolerance to blood components. It is prescribed only after consultation with doctors for heart dysfunctions, diabetes mellitus, kidney disease, migraine, during pregnancy and lactation. In case of an overdose of this medication, the side effects may worsen. An increase in the level of blood viscosity and its volume is also observed.

Where can you buy?

The drug can be produced in two forms: in the form of a dry powder and a solution, which is contained in vials. This medicine, that is, "Normal human immunoglobulin", the price of which is very different and depends on the manufacturer, the form of release and many other factors, is purchased only in pharmacy stores. Instructions for use must be attached to it. It is forbidden to use the medicine without a doctor's prescription, as there is a high risk of various side effects.

Storage conditions

It is necessary to store the drug in a dry, dark place out of the reach of children, perhaps even in the refrigerator. The storage temperature is 2-10 degrees Celsius. It is not recommended to freeze this medication. must be indicated on the package. When the drug expires, it is not suitable for use. Before using human immunoglobulin, it is imperative to consult with your doctor.

Children's immunity begins to form long before birth. Passing from the mother to the fetus, the 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 collision with pathogens of various diseases. If the body is unable to cope with the tasks set, then it can be helped with the help. Use is a common practice in the field of pediatrics. Depending on the state of the child's body, age, environmental conditions, the doctor selects an individual remedy. Immunoglobulin for children is prescribed in the form of injections in especially difficult situations.

Medical statistics show that the most common means containing immunoglobulin are used by parents of children starting to attend educational institutions. Getting into places of large crowds of people, the baby is faced with 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 the protective properties.

Release form and composition

For human immunoglobulin, a single dosage form is provided - a solution. The method of injection is set in accordance with the indications, age and condition of the little patient's body. The following stimulant options are available at the pharmacy:

solution for intramuscular use (the dose of the drug in one ampoule is 1, 1.5, 3 ml, available in packs of 5 or 10 units);
solution for intravenous jet injection (dose of the drug in a bottle of 25 or 50 ml, produced one unit per package);
solution for setting droppers (drug dose 25, 50, 100 ml, produced one unit in a 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 preparation for intravenous jet injection includes 50 mg;
1 ml of intravenous solution, administered by drop, contains 50 mg.

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

Indications for use

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

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

It is impossible to assess visually 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 with complications, acquisition of immunodeficiency status, frequent relapses chronic diseases, serious allergic reactions, changes in the performance of body systems. When you study the instructions for using human immunoglobulin, you can find out that it is prescribed according to the indications:

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

To raise the immunity of a child in order to prevent immunoglobulin is administered in case of autoimmune disorders, variable immunodeficiency. A medication is used in children who have low body resistance and have come into contact with dangerous infectious diseases. The introduction of immunoglobulin to a newborn is indicated when interacting 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 a 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 antibiotic treatment.

Contraindications

Despite the fact that the drug is used to increase immunity and has benefits for the body, it has its own contraindications. It is not recommended to drip, inject intravenously and intramuscularly the solution under the following conditions:

increased sensitivity of the child to the active ingredient;
deficiency of immunoglobulins A caused by the presence of antibodies in the body;
exacerbation of chronic allergic reactions;
failure of kidney function;
diabetes;
the likelihood of developing anaphylactic shock on 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, then the baby should be temporarily weaned to prevent the drug from entering his body without an indication for this. For diseases provoked by immunopathological processes, the solution is used only under the supervision of a physician.

Often, parents have a question about the age at which an injection of immunoglobulin can be given. The manufacturer of the drug does not indicate age restrictions. Injections, if indicated, are prescribed both for a child in the first days of life and at an older age. It is important to find the appropriate dosage for the medication.

Method of administration and dosage

The instructions for use attached to the drug allow the administration of immunoglobulin to children in the form of injections by three different ways... The method of use is selected according to the indications, general condition organism, concomitant diseases, the age of the baby and anamnesis.

Unlike an adult, children are more sensitive to various kinds of medical manipulations. Therefore, in babies, often with the introduction of a stimulating substance, the body temperature rises. 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 institution, so that, if necessary, a small patient is provided with timely qualified assistance.

Before using the medication, it is necessary to keep the solution in an ampoule at room temperature. If turbidity and impurities are present in it, then such an injection cannot be used. During the injection, it is important to follow the rules of asepsis.

Intramuscularly

Intramuscular administration of the drug to children is carried out in upper part thighs or buttocks. Infusion with this solution is prohibited. The liquid from the ampoule is drawn 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 set individually for the child:

hepatitis A - for children preschool age 0.75 ml, at 10 years old 1.5 ml, for children over 3 ml (the second injection 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 per day (no more than 3 days should pass from the moment of contact);
meningococcal infection - for infants 1.5 ml, for kindergarten children 3 ml (no later than 7 days from contact);
flu - once for babies up to 2 years old 1.5 ml, for kindergarten children 3 ml, for schoolchildren up to 6 ml (in severe cases, the procedure may be repeated after 1 or 2 days);
poliomyelitis - 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 of 0.15 ml per kilogram, up to 4 injections with a break of 48-72 hours.

With blood counts indicating a decrease in immunoglobulins, the child is injected with the drug in a volume equal to his body weight (1 ml per kilogram). Re-use of the medication is permissible no earlier than after 30 days.

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 with:
- agammaglobulinemia;
- bone marrow transplant;
- syndrome of primary and secondary immunodeficiency;
- chronic lymphocytic leukemia;
- variable immunodeficiency associated with agammaglobulinemia;
- AIDS in babies.

Also, the product is 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 babies;
- Guillain-Barré Syndrome;
- Kawasaki syndrome (as a rule, in combination with the standard l / s for this disease);
- neutropenia of autoimmune origin;
- chronic demyelinating polyneupropathy;
- hemolytic anemia of autoimmune origin;
- erythrocyte aplasia;
- thrombocytopenia of immune origin;
- hemophilia caused by the synthesis of antibodies to factor P;
- treatment of myastenia gravis;
- prevention of habitual 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. Also, the product 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%. A gradual redistribution of the active substance of the product takes place between the extravascular space and human plasma. Equilibrium between these media is achieved in about 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 the state of his immune system.

Immunoglobulin contraindications:
The drug should not be used when:
- hypersensitivity to human immunoglobulins;
- deficiency in IgA 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 in migraine, pregnancy and lactation, decompensated chronic heart failure. Also, if there are diseases in the genesis of which immunopathological mechanisms are the main ones (nephritis, collagenosis, immune diseases of the blood), then the product should be prescribed with caution after the conclusion of a specialist.

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

The manifestation of effects is most likely when the product is taken for the first time: within the first hour. It can be a flu-like syndrome - malaise, chills, high body temperature, weakness, headache.

The following symptoms from the outside 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, not often symptoms of aseptic meningitis - nausea, vomiting, headache, light sensitivity, impaired consciousness, stiff neck);
- kidney (not often acute tubular necrosis, worsening of renal failure in patients with impaired renal function).

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

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

Pregnancy:
There have been no studies on the effects 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 case of extreme need, when the benefits of the drug significantly outweigh the possible risk to the baby.

The product should be used with caution during lactation: it is known that it penetrates into breast milk and promotes the transmission of protective antibodies infant.

Overdose:
Overdose symptoms may appear with intravenous administration of the product - these are high blood viscosity and hypervolemia. It is especially important for people in old age or with impaired renal function.

Use with others drugs:
The drug is pharmaceutically incompatible with other drugs. It should not be mixed with other products, always use a separate dropper for infusion. With the simultaneous use of Immunoglobulin with active immunization drugs for viral diseases such as rubella, chickenpox, measles, mumps, the effectiveness of treatment may decrease. If you need parenteral administration of live viral vaccines, 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 injected, then its effect can last for a year. Also, you cannot use this product 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 (intravenous injection), solution for intramuscular injections.

Storage conditions:
The drug must be stored in a warm, dark place. The storage temperature must be 2-10 ° C, the drug should not be frozen. The storage period will be indicated on the package. After this period, use of the product is prohibited.

Synonyms:
Immunoglobin, Imogam-RAZH, Intraglobin, Pentaglobin, Sandoglobin, Cytopect, Immunoglobulin human normal, Immunoglobulin antistaphylococcal human, Immunoglobulin against human tick-borne encephalitis liquid, Immunoglobulin anti-tetanus encephalitis, Human Immunoglobulin, Human Immunoglobulin, Immunoglobulin Cytotect, Humaglobin, Octagam, Intraglobin, Endobulin S / D

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

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

The protective effect of this product begins to manifest itself 24 hours after ingestion, its duration is 30 days. In patients with a tendency to migraine or with impaired renal function, increased caution should be exercised. You should also know that after the use of Immunoglobulin, a passive increase in the amount of antibodies in the blood is observed. With serological testing, this can lead to misinterpretation of the results.

From pharmacies, the drug is dispensed with a doctor's prescription.

Attention!
Before using the medication "Immunoglobulin" it is necessary to consult a doctor.
The instruction is provided solely for acquaintance with " Immunoglobulin».