Human immunoglobulin instructions for use for children. Prevention of various ailments. Interaction with other drugs

Composition of the medicinal product Immunoglobulin

Active ingredient: Normal human immunoglobulin.

Dosage form

lyophilized powder for preparation injection solution

Pharmacotherapeutic group

Immunoglobulins

Pharmacological properties

Immunostimulating. Increases the level of antibodies in the body. With intravenous infusion, bioavailability is 100%. Redistribution of the drug occurs between the plasma and the extravascular space, and equilibrium is reached after approximately 7 days. In individuals with normal serum IgG levels, the biological half-life averages 21 days, while in patients with primary hypo- or agammaglobulinemia it is 32 days. Contains wide range opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replenishment of missing IgG antibodies, which reduces the risk of infection.

Indications for use Immunoglobulin

Replacement therapy to prevent infections in syndromes primary immunodeficiency: agammaglobulinemia, common variable immunodeficiencies associated with a- or hypogammaglobulinemia; deficiency of IgG subclasses, replacement therapy to prevent infections in secondary immunodeficiency syndrome due to chronic lymphocytic leukemia, pediatric AIDS or transplantation bone marrow, idiopathic thrombocytopenic purpura, Kawasaki syndrome (in addition to drug treatment acetylsalicylic acid), severe bacterial infections, including sepsis (in combination with antibiotics) and viral infections, prevention of infections in premature infants with low birth weight (less than 1500 g), Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy, autoimmune neutropenia, partial red cell aplasia of hematopoiesis, thrombocytopenia of immune origin, incl. post-transfusion purpura, isoimmune thrombocytopenia of newborns, hemophilia caused by the formation of antibodies to coagulation factors, myasthenia gravis, prevention and treatment of infections during therapy with cytostatics and immunosuppressants, prevention of recurrent miscarriage.

Contraindications

Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.

Cautions for use

Majority side effects is associated with a high infusion rate and can be managed by stopping or slowing the infusion. If severe side effects occur, administration should be discontinued (adrenaline, antihistamines, corticosteroids and plasma expanders may be indicated). If renal function is impaired, it is recommended to monitor the condition of patients during treatment (monitor creatinine within 3 days after infusion). After the administration of immunoglobulin, the content of antibodies in the blood increases (passively), which can lead to erroneous interpretation of the results of a serological test.

Interactions with drugs

May reduce the effectiveness of active immunization: live viral vaccines for parenteral use should not be used for at least within 30 days after administration of immunoglobulin.

Side effects

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

Immunoglobulin human normal contains an active ingredient - immunoglobulin fraction. It is initially isolated from human plasma, after which it is purified and concentrated. The drug does not contain human immunodeficiency viruses and hepatitis C, it does not contain . The protein concentration is 4.5% - 5.5%. Low anti-complementary activity of the drug is noted.

Release form

Immunoglobulin preparations are available in two forms. This is a solution for intramuscular injections and dry powder for infusion (Immunoglobulin IV). The solution is a clear or slightly opalescent liquid without color.

pharmachologic effect

This medicine has immunostimulating And immunomodulatory action . It contains many opsonizing and neutralizing antibodies. Their presence provides effective resistance to bacteria, viruses and a number of other pathogens.

Under the influence of this remedy, the amount of missing IgG antibodies. As a result, the risk of developing infection in people diagnosed with primary and secondary is reduced. Immunoglobulin replenishes and replaces natural antibodies in human serum.

To understand the essence of the effect of this drug on the body, you should understand how immunoglobulin works in the human body, what it is. Wikipedia indicates that immunoglobulins are unique immune molecules that are capable of neutralizing a number of toxins and many pathogens in the human body.

To neutralize certain type viruses or bacteria, the body produces unique types of immunoglobulins. There is a classification according to which classes of immunoglobulins are determined depending on antigenic characteristics, properties, and structure.

If necessary, a blood test is performed for immunoglobulin, general and specific. This examination allows us to determine the presence allergic diseases and appoint correct treatment. A specialist can decipher the results of the analysis in detail, determining whether immunoglobulin is elevated (the norm of its content depends on the person’s age). If a certain class is increased, a specialist will explain in detail what this means.

Pharmacokinetics and pharmacodynamics

When conducting intravenous infusion the level of bioavailability is 100%. The highest concentration of antibodies in human blood is observed during 14 days. The half-life of antibodies is 4-5 weeks. The drug penetrates the placenta and enters breast milk.

Indications for use

Human normal immunoglobulin is indicated as a replacement treatment if the patient needs to undergo replacement treatment for the purpose of replacing and replenishing natural antibodies.

To prevent infections, it is prescribed in the following cases:

• during a bone marrow transplant;
• with agammaglobulinemia;
• in case of primary and secondary immunodeficiency, with variable immunodeficiency;
• at , which is chronic;
• in children;
• with thrombocytopenic purpura, which is of immune origin;
• for severe bacterial and viral infections;
• for Kawasaki Syndrome;
• for Guillain-Barre Syndrome;
• with erythrocyte aplasia;
• with neutropenia of autoimmune origin;
• with chronic demyelinating polyneuropathy;
• at hemolytic anemia and thrombocytopenia of autoimmune origin;
• at , provoked and caused by the synthesis of antibodies to factor P;
• during treatment of myasthenia gravis;
• in order to prevent habitual ;
• for the prevention of infectious diseases in premature newborns.

Contraindications

Determined the following contraindications to use this drug:

• to human immunoglobulins;
• IgA deficiency due to the presence of antibodies to it;
• V acute form;
• for blood products.

When prescribing a drug, one should take into account not only contraindications, but also those conditions and diseases for which treatment should be carried out with caution.

The remedy is prescribed very carefully to people suffering from decompensated heart failure chronic, and pregnant women , mothers during natural feeding . With caution and only after a doctor’s prescription, therapy is administered to people suffering from diseases whose origin is associated with immunopathological mechanisms ( collagenosis , nephritis , immune blood diseases ).

Side effects

If a patient is prescribed normal human immunoglobulin, and the correct scheme treatment, dosage and administration characteristics, then pronounced side effects rarely occur. However, it should be noted that side effects may occur several hours or even days after the drug has been administered. In most cases negative manifestations disappear completely after the drug is stopped.

Mostly, side effects are observed due to too high a rate of drug infusion. If you pause the injection for a while or reduce its speed, then most negative effects will disappear. If negative symptoms do not stop, it is necessary to practice symptomatic treatment.

More often side effects are observed when Immunoglobulin is administered to a person for the first time, and they develop during the first hour. These may be the following symptoms:

• flu-like syndrome ( increase in body temperature , chills , weakness );
• , ;
• vomit, heavy salivation, stomach pain;
• , cyanosis , flushing of the face, painful sensations in the chest;
• weakness , sensitivity to light, disturbances of consciousness, in in rare cases– signs of aseptic ;
• in rare cases, acute tubular necrosis occurs; the condition may worsen in people with renal failure;
• allergic manifestations ;
• local reactions.

In addition to the above symptoms, there may be a feeling of aching joints, myalgia , sweating , backache. Loss of consciousness is very rare, collapse , severe hypertension. If the reaction to therapy is very severe, treatment should be discontinued. If necessary, you can enter antihistamines, solutions that replace plasma.

Instructions for use of Immunoglobulin (Method and dosage)

The instructions for Immunoglobulin provide for the possibility of intravenous drip and intramuscular injection medicines. Typically, the dose of the drug is prescribed at individually, taking into account the severity of the disease, condition, etc.

Instructions for using the medicine for children include the administration of 3-4 ml of the drug per 1 kg of the child’s weight, and the dose should not exceed 25 ml. Before administration, Immunoglobulin must be diluted with 0.9% sodium chloride solution (sterile) or 5% glucose solution, respectively, 1 part of the drug and 4 parts of the solvent. It is administered intravenously, at a rate of 8–10 drops per minute. Infusions are given over 3–5 days.

Adult patients receive a single dose of 25–50 ml. There is no need to dilute the drug additionally; it is administered intravenously at a rate of 30–40 drops per minute. The course of treatment includes 3–10 transfusions, which are carried out every 24–72 hours.

If the question arises where to place an IV, it should be taken into account that the drug can be administered intravenously only in a hospital, and it is important to strictly observe the requirements of asepsis. Where you can get an Immunoglobulin injection, you can find out at your nearest medical institution. You can also obtain information under what conditions Immunoglobulin is administered to children free of charge.

Before administering the product, the bottle must be kept at a temperature of 18 to 22 °C for at least 2 hours. If the solution is cloudy or contains sediment, it should not be administered.

Overdose

Signs of an overdose of the drug may occur when administered intravenously. These symptoms are hypervolemia And high blood viscosity . Overdose symptoms are more likely to occur in older people and in patients with kidney disease.

Interaction

Pharmaceutical incompatibility of the drug with other medications is noted. It should not be mixed with other drugs; you should always use a separate dropper for Immunoglobulin.

The effectiveness of the drug may decrease if it is administered at the same time as immunization drugs at, at, at.

If there is a need to use parenteral live viral vaccines for chickenpox, etc., they can be used 1 month after treatment with Immunoglobulin, but it is advisable to take a break of 3 months.

The product should not be used simultaneously with when treating children infancy.

Terms of sale

IN pharmacy chains Sold by prescription.

Storage conditions

It is necessary to transport and store the drug in accordance with SP 3.3.2.038–95, temperature regime— 2-8 °C. Cannot be frozen.

Best before date

Shelf life: 1 year. Cannot be used after this period has expired.

special instructions

Patients who have been diagnosed with diseases whose origin is associated with immunological mechanisms can use Immunoglobulin only after consultation with a doctor involved in the treatment of such diseases.

The administration of the medicine must be registered in the appropriate accounting form, in which the series, number, date of manufacture, expiration date, date of administration, dosage and reaction to receiving the drug must be indicated.

The use of the drug is not allowed if the container with it has been damaged. After opening the container, the medicine is used as a cut; it cannot be stored open.

The protective effect of the drug is observed after 24 hours and continues for 30 days.

After using Immunoglobulin, a passive increase in the amount of antibodies in the blood is observed. Therefore, when blood is donated for analysis, the interpretation of the blood test for immunoglobulin may subsequently be incorrect.

Patients who are diagnosed allergic diseases or celebrated penchant for allergic manifestations , should receive antihistamines on the day of administration of the solution and for eight days after receiving it.

After the drug has been administered to the patient, it is necessary to monitor him for another half hour. The specialist must have access to anti-shock therapy.

For children

The drug can be prescribed to children if indicated, but it is important to strictly adhere to the dosage described in the instructions.

With alcohol

Immunoglobulin and alcohol are incompatible, since alcohol is an immunosuppressant and impairs the functioning of immune system person. When drinking alcohol during treatment with this drug, the likelihood of developing side effects. In addition, diseases and conditions that require the use of Immunoglobulin require a categorical ban on alcohol consumption.

Immunoglobulin during pregnancy and lactation

Information about harm caused by prescribing the drug for pregnant absent. However, intravenous administration or injection of Immunoglobulin during pregnancy is carried out only if there are clear indications.

When discussing the effectiveness of Immunoglobulin, women leave different reviews, noting that the drug can alleviate the condition of many diseases, in particular, etc. When using the medicine, it is practiced with caution, since it passes into breast milk and ensures the transfer of antibodies to the baby. For women after childbirth, the drug is administered if indicated.

Human immunoglobulin contains the main active ingredient- immunoglobulin fraction. Initially, it is isolated from human plasma, and then it is purified and concentrated. The drug does not contain antibodies to human immunodeficiency viruses and hepatitis C. It also does not contain antibiotics. The protein concentration level reaches 5.5%. The medicine has low anti-complementary activity. It is an immunological agent.

Pharmacological forms

Immunoglobulin-based medications 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 exerting immunomodulatory and immunostimulating effects. It contains a large number of neutralizing and opsonizing antibodies. Thanks to them, effective resistance to various bacteria and viruses is ensured.

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

Pharmacodynamics and pharmacokinetics

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

Indications for use

Human normal immunoglobulin is used when carrying out replacement therapy, if the patient requires treatment aimed at replenishing and replacing natural antibodies.

The medicine can be used with for preventive purposes when:

1. The need to prevent diseases of infectious etymology in newborns born prematurely.
2. The need to prevent miscarriage.
3. Hemophilia, which was provoked by the process of synthesis of antibodies to factor P.
4. Thrombocytopenia and hemolytic anemia, the origin of which is autoimmune.
5. Chronic demyelinating polyneuropathy.
6. Neutropenia of autoimmune origin.
7. Erythrocyte aplasia.
8. Guillain-Barre syndrome.
9. Kawasaki syndrome.
10. Infections of viral and bacterial etymology with a severe course.
11. Thrombocytopenic purpura of immune origin.
12. AIDS in childhood.
13. Lymphocytic leukemia, which is chronic.
14. Variable immunodeficiency.
15. Primary and secondary immunodeficiency.
16. Agammaglobulinemia.
17. The need for bone marrow transplantation.

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

Contraindications for use

Given medicine should not be used if the patient has:

1. Anaphylactic reaction to blood products.
2. Diabetes.
3. Insufficient kidney function.
4. Hypersensitivity to human immunoglobulins.
5. Acute forms of allergic reactions.
6. 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, chronic form, pregnant women, breastfeeding women. 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 instructions side effects rarely develop. However, it is important to take into account that the development unwanted effects may occur several hours or days after the drug was administered to the patient. Most often, all side effects completely disappear after stopping immunoglobulin therapy.

The main reason why they develop negative impacts, – high speed administration of medication. Reducing the rate of administration or stopping its administration allows you to get rid of negative factors. If they do not disappear, then it is recommended to stop therapy completely.

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

1. Local skin reactions.
2. Allergic reactions.
3. Aseptic meningitis, impaired consciousness, photosensitivity, drowsiness and weakness.
4. Chest pain, hot flashes, cyanosis, tachycardia.
5. Stomach pain elevated department saliva, diarrhea, vomiting.
6. Shortness of breath, dry cough.
7. Flu-like syndrome: body temperature rises, chills, weakness develop, and headaches occur.

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

Dosage and Application

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

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

Adults are advised to use a dosage of 25-50 ml per application. Additional dilution of the drug is not required. The infusion is performed 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 administration, be sure to keep the solution at room temperature for up to 2 hours. If a precipitate appears or the solution becomes cloudy, stop using it.

Prevention of various ailments

The medication is also used for preventive purposes:

• For 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.
• To prevent 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 influenza 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 polio: 3-6 ml once.

Overdose

Human immunoglobulin intramuscularly is usually well tolerated. At intravenous administration medication, it is possible that symptoms of overdose may occur. They are expressed in hypervolemia and increased blood viscosity. Most often, overdose occurs in elderly patients and those who suffer from kidney disease.

Interaction with other drugs

Pharmaceutically, the 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 parallel 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 product in infants with calcium gluconate is prohibited.

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

Analogues

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

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

Also analogues of the drug include:

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

They all have the same composition active ingredients, with the same therapeutic effect.

This group of drugs is available only with a doctor's prescription. The doctor selects an individual dosage for each patient.

Cost of the drug

The cost of a drug intended for intramuscular administration averages 900 rubles per package containing 10 ampoules. average cost a drug intended for intravenous infusion will be about 2,600 rubles per 25 ml bottle.

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 product is also used for:
- thrombocytopenic purpura of immune origin;
- heavy bacterial infections, such as sepsis (in combination with antibiotics);
- viral infections;
- prevention of various infectious diseases in premature infants;
- Guillain-Barre syndrome;
- Kawasaki syndrome (usually in combination with the standard diseases for this disease);
- neutropenia of autoimmune origin;
- chronic demyelinating polyneuropathy;
- hemolytic anemia 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.

Pharmachologic effect:
The drug is an immunomodulatory and immunostimulating agent. Contains a large number of neutralizing and opsonizing antibodies, thanks to which it effectively resists viruses, bacteria and other pathogens. The product also replenishes the number of missing IgG antibodies, thereby reducing the risk of infection in 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%. There is a gradual redistribution of the active substance of the product between the extravascular space and human plasma. Equilibrium between these environments is achieved in approximately 1 week.

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

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

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

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

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

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, light sensitivity, impaired consciousness, stiff neck);
- kidneys (not often acute tubular necrosis, worsening renal failure in patients with impaired renal function).

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

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

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

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

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

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

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

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

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

Immunoglobulin composition:
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 viruses and human immunodeficiency, it does not contain antibiotics.

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

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

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

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

Normal human immunoglobulin

Instructions for use

Human immunoglobulin normal, solution for intramuscular administration.

R N001544/01 dated 07/08/2008

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

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

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

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

Immunological properties.

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

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

Purpose.

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

Directions for use and dosage.

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

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

The drug cannot be stored in an opened ampoule. The drug is unsuitable for use in ampoules with damaged integrity or labeling, if the physical properties(change in color, cloudiness of the solution, presence of flakes that do not break), when expired suitability and non-compliance with storage conditions.

The dose of immunoglobulin and the frequency of its administration depend on the indications for use.

Prevention of hepatitis A.

The drug is administered once in doses: children from 1 to 6 years old - 0.75 ml: 7-10 years old - 1.5 ml; over 10 years old and adults - 3 ml.

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

Prevention of measles.

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

Prevention and treatment of influenza.

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

Prevention of whooping cough.

The drug is administered twice with an interval of 24 hours in a single dose of 3 ml to children who have not had whooping cough and who have not been vaccinated (not fully vaccinated) against whooping cough, as much as possible early dates after contact with the patient, but not later than 3 days.

Prevention of meningococcal infection.

The drug is administered once to children aged 6 months to 7 years no later than 7 days after contact with a patient with a generalized form of meningococcal infection in doses of 1.5 ml (children under 3 years old) and 3 ml (children over 3 years old).

Prevention of polio.

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

Treatment of hypo- and agammaglobulinemia in children.

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

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

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

Side effects.

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

Interactions with other drugs.

Not installed.

Contraindications.

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

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

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

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

Administration of immunoglobulin and preventive vaccinations.

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

Release form.

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