Human immunoglobulin normal 25 ml instructions. Side effects of immunoglobulin. General characteristics. Compound

Composition of the medicinal product Immunoglobulin

Active ingredient: Normal human immunoglobulin.

Dosage form

lyophilized powder for the preparation of 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 persons with normal content IgG in serum has a biological half-life of 21 days on average, while in patients with primary hypo- or agammaglobulinemia it is 32 days. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replenishment of missing antibodies IgG class, which reduces the risk of infection.

Indications for use Immunoglobulin

Replacement therapy for the prevention of infections in primary immunodeficiency syndromes: 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, 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 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 associated with high speed infusion 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 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, fatigue, malaise, back pain, myalgia, numbness, hot flashes or a feeling of cold.

Immunoglobulin is an immunostimulating drug.

Release form

The drug is available in the form of a solution for intramuscular and intravenous administration, as well as in the form of a powder for injection.

pharmachologic effect

Immunoglobulin is a globular protein that is produced by special cells of the human body. Globular protein takes an active part in the formation of the immune response.

Exist different kinds proteins, including immunoglobulin G, immunoglobulin E, human immunoglobulin, anti-Rhesus immunoglobulin, immunoglobulins M and A. All these proteins differ in amino acid composition, structure and functions.

Immunoglobulin G accounts for about 70% of all serum proteins. Its most important functions include the ability to penetrate the placental barrier in order to provide the newborn with natural passive immunity. Immunoglobulin G takes part in the development of the immune response, participates in the activation of complement, and enhances phagocytosis. The production of this type of protein requires the presence of T lymphocytes. Taking immunosuppressants and radiation help suppress immunoglobulin G.

Immunoglobulin M accounts for 5-10% of total number proteins. This type protein is the first to be synthesized in the newborn body. Immunoglobulin M is an early antibody that fights viruses and gram-negative bacteria. The protein takes part in the activation of complement and enhances phagocytosis. This group of proteins includes antibodies against streptococcus, cold agglutinins, blood group agglutinins, rheumatoid factor. They help attract phagocytes to the site of infection and activate phagocytosis. Immunoglobulins M are weakly specific - they can simultaneously bind up to 5 antigen molecules. Thus, large immune complexes, which leads to the rapid removal of antigens from circulation and does not allow them to attach to cells.

The norm of immunoglobulin in children should be: at 1-3 months of a baby’s life - 0-2 kU/l, at 3-6 months - 3-10 kU/l, at 1 year - 8-20 kU/l, at 5 years - 10-50 kE/l, at 15 years old – 16-60 kE/l. For adults, the norm is 20-100 kE/l.

Immunoglobulin A accounts for 10-15% of the total. It is found in tears, saliva, gastric secretions, intestinal secretions, lungs, vagina, genitourinary tract, bronchi. A large amount of protein is contained in breast milk, thanks to this, during natural feeding, the baby is protected from the first days. This type of protein helps neutralize bacterial toxins and viruses, and also provides protection to mucous membranes.

Human immunoglobulin is different high content antibodies that fight various pathogens. It helps reduce the likelihood of contracting infections in patients with immunodeficiency and replenishes the lack of G-antibodies.

Anti-Rhesus immunoglobulin is introduced into a woman’s body during pregnancy when an Rh conflict is detected to prevent Rh sensitization. Protein promotes the destruction of fetal red blood cells with Rh positive in the mother's bloodstream, preventing the production of anti-Rhesus maternal antibodies.

Indications

Immunoglobulin G is prescribed for liver cirrhosis, infectious diseases, viral and chronic autoimmune hepatitis, dermatomyositis, myeloma, systemic lupus erythematosus, AIDS, rheumatoid arthritis, HIV infections, sepsis, meningitis, sinusitis, oncopathologies, otitis media, pneumonia.

Immunoglobulin E is effective for such allergic diseases as food drug allergy, hay fever, atopic dermatitis, eczema, bronchial asthma, helminthiases. The drug is also used to assess the development of allergies in children.

Human immunoglobulin should be taken for congenital hypogammaglobulinemia, agammaglobulinemia, severe combined immunodeficiency, deficiency of immunoglobulin G subclasses, for replacement therapy for myeloma, AIDS in children, chronic lymphocytic leukemia.

Anti-Rh immunoglobulin is prescribed to women who are Rh negative, in which Rh antibodies are not produced. It is also taken if it is necessary to terminate a pregnancy. artificially in women who are Rh negative.

Instructions for use (method and dosage)

The drug is administered intravenously or intramuscularly. The method of administration of the drug is determined by the doctor. The immunoglobulin level is determined by a specialist individually in each case, depending on the diagnosis.

Side effects

When taking certain levels of immunoglobulin in each special case Side effects are extremely rare. As a rule, after completing the course they disappear almost immediately.

As a result of taking the drug, the patient may experience a dry cough, tachycardia, shortness of breath, stomach pain, diarrhea, nausea, cyanosis, chest pain, vomiting, drowsiness, sweating, hiccups. Side effects also include the occurrence of an allergic reaction, back pain, joint pain, necrosis of the renal tubules, and increased salivation.

Contraindications

The drug should not be taken if you have diabetes mellitus. renal failure, anaphylactic shock, acute stage allergies. The drug is prescribed with caution to pregnant women, during lactation, for chronic decompensated cardiac failure, and migraines.

Name:

Immunoglobulin (Immunoglobulinum)

Pharmacological
action:

The drug is 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 drug 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.

At intravenous administration the bioavailability of the drug is 100%. A gradual redistribution of the active substance of the drug occurs between the extravascular space and human plasma. Equilibrium between these environments is achieved on average within 1 week.

Additionally:

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

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

Indications for
application:

The drug is prescribed for replacement therapy if there is a need to replenish and replace natural antibodies.

Immunoglobulin is used for the prevention of infections at:
- agammaglobulinemia;
- bone marrow transplantation;
- primary and secondary immunodeficiency syndrome;
- chronic lymphocytic leukemia;
- variable immunodeficiency associated with agammaglobulinemia;
- AIDS in children.

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

Mode of application:

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

Side effects:

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

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

There are also following symptoms from the side:
- respiratory system (dry cough and shortness of breath);
- digestive system (nausea, diarrhea, vomiting, stomach pain and increased salivation);
of cardio-vascular 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);
- kidney(rarely acute tubular necrosis, worsening renal failure in patients with impaired renal function).

Also possible allergic(itching, bronchospasm, skin rash) And local(hyperemia in place intramuscular injection) reactions. Other side effects include: myalgia, aching joints, back pain, hiccups and sweating.

Very in rare cases collapse, loss of consciousness and severe hypertension were observed. In data severe cases discontinuation of the drug is necessary. It is also possible to introduce antihistamines, adrenaline and plasma replacement solutions.

Contraindications:

The drug should not be used when:
- 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 migraine, pregnancy and lactation, 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 drug should be prescribed with caution after the conclusion of a specialist.

Interaction
other medicinal
by other means:

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

Immunobiological agent, highly purified polyvalent human immunoglobulin. Immunoglobulin contains about 90% monomeric IgG and a small fraction of decomposition products, dimeric and polymeric IgG and IgA, IgM in trace concentrations. The distribution of IgG subclasses in it corresponds to their fractional distribution in human serum. Possesses wide range opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients with primary or secondary immunodeficiency syndromes, it provides replenishment of missing IgG class antibodies, which reduces the risk of developing infection. In some other immune disorders, such as idiopathic (immune origin) thrombocytopenic purpura and Kawasaki syndrome, the mechanism clinical effectiveness immunoglobulin is not entirely clear.
After IV infusion, a redistribution of immunoglobulin occurs between the blood plasma and the extravascular space, and equilibrium is achieved after approximately 7 days. Antibodies present in exogenous immunoglobulin have the same pharmacokinetic characteristics as antibodies in endogenous IgG. In individuals with normal serum IgG levels, the biological half-life of immunoglobulin averages 21 days, while in patients with primary hypogammaglobulinemia or agammaglobulinemia, the half-life of total IgG averages 32 days (however, there is significant individual variation that may be important when establishing a dosage regimen for a particular patient).

Indications for use of the drug Human immunoglobulin

Replacement therapy for the prevention of infections in primary immunodeficiency syndrome: agammaglobulinemia, common variable immunodeficiencies caused by agammaglobulinemia or hypogammaglobulinemia, deficiency of IgG subclasses;
replacement therapy to prevent infections in secondary immunodeficiency syndrome caused by chronic lymphocytic leukemia, AIDS in children, bone marrow transplantation;
idiopathic (immune origin) thrombocytopenic purpura;
Kawasaki syndrome (usually as an adjunct to standard treatment with acetylsalicylic acid);
heavy 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;
neutropenia of autoimmune origin and autoimmune hemolytic anemia;
antibody-mediated true red cell aplasia;
thrombocytopenia of immune origin, for example post-infusion purpura or isoimmune thrombocytopenia of newborns;
hemophilia caused by the formation of antibodies to factor P;
treatment of myasthenia gravis;
prevention and treatment of infections during therapy with cytostatics and immunosuppressants;
prevention of recurrent miscarriage.

Use of the drug Human immunoglobulin

IV drip. The regimen of use is determined individually, taking into account the indications, severity of the disease, the state of the patient’s immune system and individual tolerance. The dosage regimens given below are advisory in nature.
For primary immunodeficiency syndromes single dose is 200-800 mg/kg (average 400 mg/kg). Administered at intervals of 3-4 weeks to achieve and maintain a minimum level of IgG in the blood plasma of at least 5 g/l.
For secondary immunodeficiency syndromes, a single dose is 200-400 mg/kg. Administer at intervals of 3-4 weeks.
For the prevention of infections in patients undergoing bone marrow allotransplantation , the recommended dose is 500 mg/kg. It can be administered once 7 days before transplantation and then repeated once a week for the first 3 months after transplantation and once a month for the next 9 months.
For idiopathic thrombocytopenic purpura, an initial single dose of 400 mg/kg is prescribed, administered for 5 consecutive days. It is possible to prescribe a total dose of 0.4-1 g/kg once or over 2 consecutive days. If necessary, further doses of 400 mg/kg can be administered at intervals of 1-4 weeks to maintain a sufficient platelet count.
For Kawasaki syndrome, 0.6-2 g/kg is administered in several doses over 2-4 days.
For bacterial infections (including sepsis) and viral infections, 0.4-1 g/kg is administered daily for 1-4 days.
To prevent infection in premature infants with low birth weight, 0.5-1 g/kg is administered at intervals of 1-2 weeks.
For Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy, 0.4 g/kg is administered for 5 consecutive days.
If necessary, 5-day courses of treatment are repeated at intervals of 4 weeks.
Depending on the specific situation lyophilized powder can be dissolved in 0.9% sodium chloride solution, water for injection or 5% glucose solution. The concentration of immunoglobulin in any of these solutions can vary from 3 to 12% depending on the volume used.
For patients receiving immunoglobulin for the first time, it is recommended to administer it in the form of a 3% solution, and the initial infusion rate should be from 0.5 to 1 ml/min. If there are no side effects during the first 15 minutes, the infusion rate can be gradually increased to 2.5 ml/min. For patients who regularly receive immunoglobulin and tolerate it well, it can be administered at a more high concentration(up to 12%), however, the initial infusion rate should be low. If there are no side effects, the infusion rate can be gradually increased.

Contraindications to the use of the drug Human immunoglobulin

Increased sensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the presence of antibodies to IgA.

Side effects of the drug Human immunoglobulin

more likely during the first infusion; occur soon after the start of the infusion or during the first 30-60 minutes.
From the side of the central nervous system: possible headache, nausea; less often - dizziness.
From the outside digestive tract: in rare cases - vomiting, abdominal pain, diarrhea.
From the cardiovascular system: rarely arterial hypotension or AG ( arterial hypertension), tachycardia, chest tightness or pain, cyanosis, shortness of breath.
Allergic reactions: Severe hypotension, collapse and loss of consciousness have been reported very rarely.
Other: possible hyperthermia, chills, increased sweating and fatigue, malaise; rarely - back pain, myalgia; numbness, hot flashes, or cold sensation.

Special instructions for the use of the drug Human immunoglobulin

Immunoglobulin is obtained from the blood plasma of healthy donors, who, according to clinical examination, And laboratory research blood and medical history, have no evidence of transfusion-transmitted infections or blood-derived drugs.
In case of severe side effects (severe arterial hypotension, collapse), the infusion should be stopped; IV administration of adrenaline, corticosteroids, antihistamines and plasma expanders may be indicated. In patients with agammaglobulinemia or severe hypogammaglobulinemia who have never received replacement therapy immunoglobulins or who received such therapy more than 8 weeks ago, there is an increased risk of developing hypersensitivity reactions (including anaphylactic shock) when administered by rapid intravenous infusion. Therefore, rapid infusion is not recommended for these patients and should be closely monitored throughout the infusion period. A transient increase in creatinine levels has been reported after the administration of immunoglobulin to patients with impaired renal function caused by an underlying disease ( diabetes, systemic lupus erythematosus). In such patients, serum creatinine levels should be monitored for 3 days after infusion.
After the administration of immunoglobulin, a passive increase in the level of antibodies in the patient’s blood may be observed, which can lead to an erroneous false-positive interpretation of the results of serological testing.
Although there are no reports of adverse effects on the fetus or reproductive capacity, immunoglobulin should be used in pregnant women only when clearly needed.

Drug interactions Human immunoglobulin

Concomitant use of immunoglobulin may reduce the effectiveness of active immunization against measles, rubella, mumps And chickenpox. In this regard, live viral vaccines for parenteral use should not be used for 6 weeks to 3 months after the use of immunoglobulin. In case of repeated administration in doses from 400 mg to 1 g/kg in children with idiopathic thrombocytopenic purpura or other pathology, vaccination against epidemic hepatitis should be postponed for 8 months. Immunoglobulin should not be mixed in the same volume with any other medications.

Overdose of the drug Human immunoglobulin, symptoms and treatment

Not described.

List of pharmacies where you can buy Human Immunoglobulin:

  • Saint Petersburg

Immunoglobulins are called special type glycoproteins located on the surface of B cells in the form of receptors. They can also be in blood serum or tissue fluid, human, but already have the form of soluble molecules. Immunoglobulins are one of the most important links humoral immunity. Immunoglobulin E is responsible for immediate type allergies and is actively involved in anthelmintic immunity. Human anti-Rhesus immunoglobulin is produced on the basis of glycoproteins, and its main purpose is to prevent hemolytic disease in newborns.

Immunoglobulin: composition and release form

The drug is produced in the form of a lyophilized dry powder for infusion (for intravenous administration) and in the form of a solution for intramuscular injection.

The immunoglobulin fraction, a concentrate purified and isolated from human plasma, is active substance of this drug. Immunoglobulin does not contain antibiotics and antibodies to hepatitis C viruses and human immunodeficiency.

Human immunoglobulin

The drug immunoglobulin is used intramuscularly and intravenously. It is indicated for use in patients with the following diseases:
Used intramuscularly for measles, whooping cough, polio, meningococcal infection and for the prevention of hepatitis A. Intravenously - for Kawasaki disease, primary immunodeficiency, chronic lymphocytic leukemia, HIV infection, Guillain-Barré syndrome, dermatomyositis, multiple sclerosis, hyperimmunoglobulinemia E syndrome, as well as chronic form inflammatory demyelination. Widely known application this tool as a prophylaxis to prevent infectious diseases in newborns and premature infants.

Human immunoglobulin: contraindications

Human immunoglobulin is prohibited for use when:
- renal failure;
- diabetes mellitus;
- decompensated CHF;
- increased sensitivity;
- IgA immunodeficiency;
- pregnancy and lactation.

Human immunoglobulin: instructions for use

This drug is used intramuscularly for children and adults. To prevent measles, children are prescribed a dose of 1.5 - 3 ml, for adults - 3 ml once. As a prophylaxis against polio for unvaccinated children - 3-6 ml once. For the prevention of influenza, children under 2 years old - 1.5 ml., from 2 to 7 years old - 3 ml., over 7 years old - 4.5 6 ml once. When severe course illness, after 24-48 hours you can repeat the procedure. For the prevention of hepatitis A, children aged 1-6 years - 0.75 ml, from 7 to 10 years - 1.5 ml, children from 10 years and adults - 3 ml once. If it is necessary to prevent whooping cough in children who have not previously been ill, the drug is administered 3 ml twice, with a 24-hour break.

The drug for children is diluted intravenously with a 0.9% NaCl solution or a 5% dextrose solution, then administered 3-4 ml/kg (but not more than 25 ml) every day per day intravenous infusion it is necessary to use a separate dropper.

Symptoms of overdose are possible, which manifest themselves during intravenous administration as increased blood viscosity and hypervolemia. People who are elderly and have impaired kidney function should be especially careful.

Immunoglobulin: price and sale

You can buy immunoglobulin today, without special problems. It is enough to go to the nearest pharmacy or place an order on the Internet, which is becoming more common every day. When purchasing a drug, it is worth remembering that the purchase medicines from hand or in places that do not belong to specialized institutions, there is always a risk of purchasing a low-quality drug. Therefore, before you buy Immunoglobulin or any other product, you must ask the seller for a certificate confirming the quality of the product.

Immunoglobulin E price is 3000 rubles per 25 ml. is the same both in the pharmacy and when ordering online. This drug is sold in pharmacies only with a doctor's prescription.

Due to the fact that the drug has a sufficient number of side effects, although, in general, I received positive reviews, requires mandatory consultation with your doctor and familiarization with the manufacturer’s annotation directly. This instruction is presented for product information purposes only and is provided in free translation.

Immunoglobulin and Transfer factor

Immunoglobulin, the average price of which is
about 3,000 rubles per 25 ml, required for 1 day of injections, which should be carried out in a course of 3-4 days, implies that treatment with this drug will cost from 12,000 rubles, and may require repeated repetitions, and accordingly, even greater costs. The drug Transfer factor, which performs the same functions, that is, is a serious immunomodulator, immunostimulator and immunosuppressor in one bottle, costs approximately 2000 rubles. This price is indicated for a package containing 90 capsules. Transfer factor is a drug that has no contraindications and can be used both to stop the disease and to prevent its occurrence. It has no contraindications and cannot cause an overdose. It has a more dramatic effect on the human body than other drugs known today, since it has the unique ability to activate all three factions of the immune system and eliminate damage in the DNA structure, that is, eliminate the cause of the disease. It is taken orally, which is important for many, and can counteract the side effects and increase the effectiveness of other medications.



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