Treatment of severe forms of bacterial and viral infections. Treatment postoperative complications accompanied by bacteremia and septicopyemic conditions. Primary antibody deficiency syndrome is agamma- and hypogammaglobulinemia (congenital form, period of physiological deficiency in newborns). Secondary antibody deficiency syndrome. Blood diseases, consequences of immunosuppressive therapy, acquired immunodeficiency syndrome (AIDS), especially when children are infected with the human immunodeficiency virus.
Contraindications Human immunoglobulin normal solution for intravenous injection 50 mg/ml 25 ml
History of allergic reactions or severe systemic reactions to human blood products. In cases of severe sepsis, the only contraindication is a history of anaphylactic shock to human blood products. IgA immunodeficiency.
Directions for use and dosage Human immunoglobulin normal solution for intravenous injection 50 mg/ml 25 ml
Immunoglobulin for infusion is used only in a hospital setting. Before administration, the bottles are kept at a temperature of (20±2)°C for at least 2 hours. Solutions that are cloudy or contain sediment should not be used. The dose and frequency of administration of the drug depend on the indications for use. For children single dose the drug is 3-4 ml per 1 kg of weight, but not more than 25 ml. The infusion rate and duration of therapy are selected by the doctor individually. Immediately before administration, the drug is diluted with 0.9% sodium chloride solution or 5% glucose solution at the rate of 1 part of the drug and 4 parts of the diluent. Diluted immunoglobulin is administered intravenously at a rate of 8-10 drops per minute. Infusions are carried out daily for 3-5 days. For adults, a single dose of the drug is 25-50 ml. Immunoglobulin (without additional dilution) is administered intravenously at a rate of 30-40 drops per minute. The course of treatment consists of 3-10 transfusions, carried out every 24-72 hours (depending on the severity of the disease).
Immunoglobulins are a special type of glycoproteins found on the surface of B cells in the form of receptors. They can also be in the blood serum or tissue fluid of a person, but already have the appearance soluble molecules. Immunoglobulins are one of the most important components of humoral immunity. Immunoglobulin E is responsible for allergies immediate type and actively participates 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 the 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
Intramuscularly this drug used 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. In case 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 3-4 ml/kg (but not more than 25 ml) is administered every day for intravenous infusion, it is necessary to use a separate dropper.
Symptoms of overdose are possible, which appear when intravenous administration increased blood viscosity and hypervolemia. People should be especially careful old age and having impaired renal function.
Immunoglobulin: price and sale
You can buy immunoglobulin today without any 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 purchasing medications 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 amount side effects, although, in general, it has received positive reviews, it 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.
Biaven V.I.; Venoglobulin; Wigam (Wigam-liquid, Wigam-S); Gabriglobin; Gabriglobin-IgG; Gamma Globulin; Gamimun N; Gamunex; I.G. Vienna N.I.V.; Imbiogam; Imbioglobulin; Immun Inject; Immunovenin; Immunoglobulin; Immunoglobulin G; Antirotavirus immunoglobulin; Antistaphylococcal immunoglobulin; ; Human immunoglobulin normal; Intraglobin; Intratect; Octagam; Pentaglobin; Sandoglobulin; Humaglobin; Endobulin.
Normal human immunoglobulin- immunostimulating and immunomodulating agent. Effectively opsonizes microorganisms and neutralizes toxins. Replenishes missing IgG antibodies, which reduces the risk of infection in patients with primary and secondary immunodeficiencies. It is used to replace and replenish natural antibodies in the patient’s serum: agammaglobulinemia and hypogammaglobulinemia, deficiency of IgG subclasses, severe combined immunodeficiencies, chronic lymphocytic leukemia, multiple myeloma, AIDS. As a means for immunomodulation and suppression of inflammation: idiopathic thrombocytopenic purpura, Kawasaki syndrome. Used in combination treatment for severe infections of bacterial and viral origin, sepsis, iatrogenic immunodeficiency, bacterial meningitis, Guillain-Barre syndrome, demyelinating polyneuropathy, autoimmune neutropenia, anemia, thrombocytopenia, hemophilia, myasthenia gravis; for the prevention of opportunistic infections, infections in premature infants and children with low birth weight.
Active ingredient:
Human immunoglobulin normal / Immunoglobulin human normal / Immunoglobulin human normal / Immunoglobulinum humanum normale.
Dosage forms:
Solution for intravenous infusion (lyophilisate for solution preparation).
Solution for intramuscular injection.
Normal human immunoglobulin
Properties / Action:
Normal human immunoglobulin is a polyvalent human immunoglobulin. Has all the properties of immunoglobulin G found in healthy populations. Prepared from the plasma of healthy donors, who, according to clinical examination and laboratory blood tests, as well as according to anamnesis, do not show signs of infections transmitted by blood transfusion or drugs obtained from blood (in particular, tests for hepatitis B surface antigen, HIV-1, HIV-2, antibodies against hepatitis C virus etc.).
The main component of normal human immunoglobulin preparations is the immunologically active fraction of human serum protein. About 95-96% total protein represented by immunoglobulin G (IgG). According to the distribution of IgG subclasses, normal human immunoglobulin is close to the plasma of a healthy person. In small quantities, normal human immunoglobulin contains immunoglobulin M (IgM) and immunoglobulin A (IgA). Immunoglobulin solution is a colorless or light yellow, transparent or slightly opalescent solution; lyophilisate - a white porous hygroscopic mass.
Normal human immunoglobulin is an immunostimulating agent. Immunoglobulin has a wide range of opsonizing and neutralizing properties of antibodies against bacteria, viruses and other pathogens infectious diseases. In patients suffering from primary or secondary immunodeficiency syndromes, Immunoglobulin ensures the replenishment of missing IgG antibodies, which reduces the risk of infection. When used in adequate doses, it is possible to restore pathologically low IgG levels to normal.
Normal human immunoglobulin also has nonspecific and immunoregulatory activity, manifested in increasing the body's resistance and anti-inflammatory effect. In some immune disorders, such as idiopathic thrombocytopenic purpura (ITP) and Kawasaki syndrome, the mechanism of action that provides the beneficial effects of immunoglobulin G remains unclear.
The administration of Immunoglobulin G to pregnant women is at risk premature birth reduces child mortality and the threat of infection.
Pharmacokinetics:
With intravenous infusion, the bioavailability of normal human immunoglobulin is 100%. Immunoglobulin G is distributed relatively quickly between plasma and extravascular fluid. After 3-7 days, equilibrium is achieved between the vascular and extravascular systems. The biological half-life of Immunoglobulin G averages 21-34 days. There are significant individual variations in T1/2 values, which may be important when determining the dose regimen for a particular patient. In individuals with normal serum IgG levels, the biological half-life is shorter; in patients with primary hypoglobulinemia or agammaglobulinemia - longer. Immunoglobulins and immunoglobulin complexes are utilized by cells of the reticuloendothelial system.
Indications:
The indication for the use of normal human Immunoglobulin is the clinical feasibility of replacing/replenishing natural antibodies in the patient's serum. Application tested in the following cases:
For replacement therapy for the purpose of preventing infections in patients with primary immunodeficiency syndromes:
As replacement therapy for the prevention of infections in patients with secondary immunodeficiency syndrome with hypogammaglobulinemia and recurrent infections:
As a means for immunomodulation and suppression of inflammation:
As a result of the studies, the positive effects of normal human immunoglobulin were found in the following conditions:
Directions for use and dosage:
Normal human immunoglobulin is used only as prescribed by a doctor and only under conditions of compliance with all aseptic rules. Immunoglobulins for intramuscular administration are strictly prohibited from being administered intravenously.
Immunoglobulin for intravenous administration (for infusion):
Normal human immunoglobulin is administered by slow intravenous drip infusion (over 15-30 minutes). The concentration in the intravenous solution can vary from 3 to 12% depending on the volume used. The lyophilized drug can be dissolved in the supplied solvent or 0.9% sodium chloride solution (isotonic solution). Avoid shaking the bottle, which leads to foaming. The drug should completely dissolve within 10-12 minutes. Before administration, the solution must be warmed to body temperature. The drug should be inspected for the presence of particles; You can only use a clear solution. After preparing the solution, the infusion should be carried out immediately. The Immunoglobulin solution should be administered through a filter system; A separate IV should always be used for administration. Partially used vials should be thrown away.
Dosage regimens used for various indications, depend on the state immune system the patient, the severity of the disease and individual tolerance.
A single dose of Immunoglobulin is 0.05-0.2 g/kg body weight (2.5-10 g). In some cases, in severe septic-toxemic conditions, daily dose Immunoglobulin may be increased to 1 g/kg body weight. The course of treatment consists of 3-10 transfusions, performed every 24 hours (depending on the severity of the disease).
For patients receiving immunoglobulin treatment for the first time, it should be administered as a 3% solution, with an initial infusion rate of 0.5 to 1.0 mL/min (approximately 10 to 20 drops/min). If there are no side effects within the first 15 minutes, the infusion rate can be gradually increased to 2.5 ml/min (approximately 50 drops/min). Faster administration may cause the development of a collaptoid reaction.
Patients who regularly receive immunoglobulin and tolerate it well can be administered the drug at more high concentrations(up to a maximum of 12%), however, the infusion should always be started at a low speed and the patient’s condition should be carefully monitored, increasing the concentration gradually.
There are no universal rules for the use of immunoglobulin, and the following are only advisory:
Primary immunodeficiency syndromes: 0.2 to 0.8 g/kg body weight (most commonly 0.4 g/kg) at intervals of 2 to 4 weeks to achieve maintenance of minimum plasma IgG levels of at least 5 g/L ( achieved within 3-6 months from the start of treatment). Courses of treatment are repeated after 2-3 months.
Secondary immunodeficiency syndromes: from 0.2 to 0.8 g/kg body weight at intervals of 2 to 4 weeks.
At prevention of infections in patients undergoing bone marrow allotransplantation, the recommended dose is 0.5 g/kg. It can be administered once 7 days before transplant and then repeated once a week for the first three months after transplant and once a month for the next 9 months.
Idiopathic (immune origin) thrombocytopenic purpura (ITP): For initial treatment, a dose of 0.4 g/kg administered over 5 consecutive days, or 0.4 to 1 g/kg as a single dose or over two consecutive days, is used. If necessary, further doses of 0.4 g/kg may be administered at intervals of 1 to 4 weeks to maintain adequate platelet levels.
Kawasaki syndrome: from 0.6 to 2.0 g/kg in several doses over 2-5 days, usually as an addition to standard treatment with acetylsalicylic acid.
Severe infections of bacterial origin (including sepsis) and viral infections: from 0.4 to 1.0 g/kg daily for 1-4 days.
Prevention of infections in low birth weight preterm infants: from 0.5 to 1.0 g/kg at intervals of 1 to 2 weeks.
Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy: 0.4 g/kg for 5 consecutive days, repeated at 4-week intervals as needed.
At systemic diseases connective tissue(systemic lupus erythematosus, vasculitis, etc.) the drug is administered in doses of 0.2-0.4 g/kg body weight per day daily for 3-10 days.
Transfusion therapy with immunoglobulin for intravenous administration can be combined with other drugs, antibiotics, cytokines, and bacteriophages.
Immunoglobulin for intramuscular administration:
Normal human immunoglobulin is administered intramuscularly, into the upper outer quadrant of the gluteal muscle or into the outer surface of the thigh, the dose and frequency of administration depend on the indications.
Prevention of measles: from 3 months of age who have not had measles and have not been vaccinated, no later than 4 days after contact with a sick person: children - 1.5 or 3 ml (depending on health status and time since contact), adults - 3 ml once.
Prevention of polio: for unvaccinated children or who have not completed the full course of vaccination, as soon as possible after contact with a patient with paralytic polio - 3-6 ml once.
Prevention of hepatitis A: children 1-6 years old - 0.75 ml, 7-10 years old - 1.5 ml, over 10 years old and adults - 3 ml once; reintroduction according to indications no earlier than 2 months.
Prevention and treatment of influenza: children under 2 years old - 1.5 ml, 2-7 years old - 3 ml, over 7 years old and adults - 4.5-6 ml once. At severe forms influenza, repeated administration is indicated after 24-48 hours.
Prevention of whooping cough: for children who have not had whooping cough - 3 ml twice with an interval of 24 hours.
Prevention of meningococcal infection: for children from 6 months to 7 years, no later than 7 days after contact with a patient with a generalized form of infection (regardless of the serogroup of the pathogen) - 1 ml (up to 3 years inclusive) or 3 ml (over 3 years).
Overdose:
Symptoms: with intravenous administration possible: hypervolemia, increased viscosity blood (especially in patients with impaired renal function or in old age).
Contraindications:
In cases of severe sepsis, the only contraindication for immunoglobulin administration is a history of anaphylactic shock to blood products.
Normal human immunoglobulin is used with caution:
Use during pregnancy and lactation:
Studies on the effect of immunoglobulin on reproductive function have not been conducted; experience with pregnant women is limited. Although no adverse reactions to the fetus or fertility have been reported, Human Immunoglobulin Normal should be used in pregnant women only when clearly indicated.
Human normal immunoglobulin should be used with caution during lactation ( breastfeeding). Immunoglobulins pass into mother's milk and may facilitate the transfer of protective antibodies to newborns.
Side effect:
If contraindications, precautions for the use of Immunoglobulin, as well as recommendations regarding dosage and administration are observed, serious side effects in response to administration are rare. Symptoms may appear within a few hours and up to several days after the immunoglobulin infusion and, as a rule, disappear after the end of therapy. Most of the effects are related to relatively high speed infusion and can be stopped by reducing it or temporarily suspending the infusion. If side effects persist, appropriate symptomatic therapy is advisable.
Side effects are more likely to occur during the first infusion of Immunoglobulin, shortly after it starts, or during the first 30-60 minutes:
Flu-like syndrome: fever, chills, headache, weakness, malaise.
From the digestive system: nausea, vomiting, abdominal pain, diarrhea, increased salivation.
From the central nervous system: dizziness, weakness, drowsiness; in isolated cases - symptoms of aseptic meningitis (severe headache, nausea, vomiting, fever, stiff neck, photosensitivity, impaired consciousness).
From the outside cardiovascular system: fluctuations blood pressure(rarely collapse with loss of consciousness), tachycardia, cyanosis, flushing, feeling of tightness or pain in the chest.
From the outside respiratory system: dry cough, rarely - shortness of breath.
From the kidneys: in isolated cases - acute necrosis renal tubules, worsening renal failure in patients with impaired renal function (with increased serum creatinine, up to anuria).
Allergic reactions: skin rash, itching, bronchospasm; in isolated cases - anaphylactic shock (even if the patient did not show excessive sensitivity during the previous administration).
Local reactions: hyperemia at the site of intramuscular injection.
Other: aching joints, back pain, myalgia, feeling of cold, sweating, hiccups.
Special instructions and precautions:
Normal human immunoglobulin is used only as prescribed by a doctor.
The drug and solvent are not suitable for use in bottles with damaged integrity, labeling, as well as if the color of the drug and solvent changes, if the transparency of the solvent changes, if there are flakes, if the expiration date has expired, or if stored improperly. Before administration, you need to visually check whether the solution contains suspended particles. Immunoglobulin solutions that are cloudy or contain sediment should not be used. The contents of opened ampoules or vials should be used immediately; The dissolved or diluted drug cannot be stored. Due to the risk of bacterial contamination, any remaining solution should be destroyed.
Normal human immunoglobulin can only be mixed with a 0.9% sodium chloride solution or with the solvent supplied with the drug. Other drugs cannot be added to the solution, since changes in electrolyte concentration or pH value can cause denaturation or precipitation of the protein.
The administration of the drug is recorded in established accounting forms indicating the batch number, control number, expiration date, manufacturer, date of administration, dose and nature of the reaction to the administration. Do not exceed the recommended rate of administration of the drug (most side effects are associated with high infusion rates). To more accurately determine the adequate dose and intervals between administrations of normal human immunoglobulin, periodic measurement of the patient’s serum IgG level is recommended.
During the entire infusion period and for at least 30 minutes after the end of the infusion, the patient must be under medical supervision. In the room where the drug is administered, there must be means antishock therapy. If intolerance reactions occur, it is necessary to either reduce the rate of administration or interrupt it until the symptoms disappear. Severe hypotension, collapse, loss of consciousness, anaphylactic reactions and shock are observed in in rare cases. If such reactions develop, it is necessary to carry out treatment in accordance with the rules of shock therapy: the infusion should be stopped, administration of
Normal human immunoglobulin is not administered to persons with a history of allergic reactions to blood products. Persons suffering allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria), or prone to allergic reactions, administration is carried out against the background of antihistamines (Erius, Xyzal, Telfast, Kestin, Zyrtec, etc.). During the period of exacerbation of the allergic process, the administration of Immunoglobulin is carried out according to the conclusion of an allergist.
Patients with agammaglobulinemia or severe hypogammaglobulinemia who have never received immunoglobulin replacement therapy or more than 8 weeks after the last treatment session may be in a state of increased risk in relation to anaphylactoid reactions, sometimes leading to anaphylactic shock. In such patients, rapid infusion should be avoided and continuous monitoring should be performed. vital functions and maintain close monitoring throughout the infusion period. In very rare cases, Human Normal Immunoglobulin may cause a sudden drop in blood pressure associated with clinical signs anaphylaxis, even in patients who previously tolerated the administration of immunoglobulin preparations well.
A transient increase in creatinine levels has been reported after administration of immunoglobulin in several patients with impaired renal function (diabetes mellitus and systemic lupus erythematosus). In such patients, serum creatinine levels should be monitored for three days after infusion.
Particular caution should be exercised in patients with a known migraine tendency.
Persons suffering systemic diseases(diseases of the blood, connective tissue, glomerulonephritis, etc.) and diseases of the immune system, normal human immunoglobulin should be administered against the background of appropriate therapy and monitoring the function of the relevant systems.
During pregnancy, Immunoglobulin is administered only under strict indications, when the expected benefit to the mother outweighs the potential risk to the fetus.
After administration of immunoglobulin, there may be a passive increase in the level of antibodies in the patient's blood (for example, to red blood cell antigens A, B or D), which can lead to an erroneous false-positive interpretation of the results of serological testing, such as the Coombs test, haptoglobin test or reticulocyte count.
Impact on the ability to drive a car or operate machinery:
There is no indication that immunoglobulins may affect the ability to drive a car or operate machinery.
Drug interactions:
Human normal immunoglobulin should not be mixed with any other medicines and should always be infused using a separate dropper.
Concomitant use of Immunoglobulin may reduce the effectiveness active immunization against such viral diseases like measles, rubella, mumps And chicken pox. Live viral vaccines for parenteral use should not be used for at least 30 days (up to 3 months) after the last dose of Immunoglobulin infusion.
Normal human immunoglobulin should not be used simultaneously with calcium gluconate in infants, as there are suspicions that simultaneous use may cause adverse events.
Storage conditions:
Store at a temperature of 2-10°C, protected from light. Do not freeze!
The expiration date is indicated on the packaging. A drug that has expired cannot be used.
Conditions for dispensing from pharmacies - according to a doctor's prescription.
Instructions for use
Immunoglobulin instructions for use
Dosage form
Transparent or slightly opalescent colorless solution.
Compound
Active substance:
Immunoglobulin G - 50 mg.
Excipients:
Dextrose monohydrate - 10 mg;
Glycine (aminoacetic acid) - 5 mg;
Sodium chloride - 7 mg;
Water for injections - up to 1 ml.
The drug does not contain preservatives or antibiotics.
Pharmacodynamics
Characteristics of the drug. Human normal immunoglobulin is a highly purified preparation of immunoglobulin G isolated from the blood plasma of healthy donors. Each series of immunoglobulin is made from a mixture of plasma from at least 1000 donors, individually tested for the absence of hepatitis B virus surface antigen (HBsAg) and antibodies to the hepatitis C virus and the human immunodeficiency virus HIV-1 and HIV-2. The drug has low anti-complementary activity.
Immunobiological properties. The drug contains wide range specific antibodies against infectious agents that are capable of opsonization and neutralization of microbes and toxins. The administration of the drug replenishes the level of antibodies in the recipient’s blood. The drug also has nonspecific activity, which manifests itself in increasing the body's resistance. Administration of the drug restores low level immunoglobulin G to normal values.
Pharmacokinetics
The entire administered dose of the drug enters directly into the recipient’s blood immediately after administration. After approximately 6 days, equilibrium in the distribution of immunoglobulin between the intra- and extravascular beds is achieved.
Side effects
The development of adverse reactions depends on the dose and rate of administration of the drug.
According to numerous studies of immunoglobulin preparations for intravenous administration, the following side effects are possible:
Disorders of the skin and subcutaneous tissues: urticaria, rashes, itching, skin lesions;
General disorders and disorders at the injection site: chills, fatigue, fever, asthenia, flu-like condition (chills, headache, dizziness, hyperthermia, myalgia), chest pain, general malaise, pain at the injection site;
From the digestive system: nausea, vomiting, abdominal pain, dyspepsia;
From the cardiovascular system: arterial hypotension, tachycardia, cyanosis, shortness of breath. Rarely - a pronounced decrease in blood pressure, loss of consciousness, collapse.
In isolated cases, the development of reversible aseptic meningitis, transient hemolytic anemia, hemolysis, acute renal failure and hypercreatinemia. Since there is evidence that the administration of high doses of immunoglobulin leads to a relative increase in blood viscosity, a relationship is suggested between intravenous administration of immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis, especially in risk groups.
U individuals with altered reactivity, allergic reactions may develop various types, and in extremely rare cases - anaphylactic shock, in connection with which persons who received the drug should be under medical supervision for an hour. Antishock therapy must be available in the room where the drug is administered.
Selling Features
prescription
Special storage conditions
Freezing is not allowed.
Special conditions
During administration of the drug, the patient's condition should be carefully monitored.
For all patients receiving immunoglobulin, it is necessary to carry out adequate hydration (consume a sufficient amount of fluid) before starting the infusion, monitor diuresis, monitor plasma creatinine concentrations, and exclude the use of loop diuretics.
The administration of immunoglobulin can lead to a transient increase in various passively transferred antibodies in the patient’s blood and to false positive results serological tests (for example, Coombs test).
Due to the presence of glucose in the drug, it is possible to increase the concentration of glucose in the patient’s blood, which affects the result of its determination. Increased values blood glucose concentrations are determined during the period of drug administration and within 15 hours after drug administration. This fact must be taken into account when prescribing therapy for patients with diabetes.
The administration of the drug should be registered in established registration forms indicating the name of the drug, batch number, release date, expiration date, manufacturer, date of administration, dose and adverse reactions to the drug.
Impact on the ability to drive vehicles. Wed and fur.:
Information about possible impact medicinal product on the ability to manage vehicles, mechanisms. The drug does not affect the ability to drive vehicles, operate machinery, or perform activities requiring increased concentration attention and speed of psychomotor reactions.
Indications
The drug is used without age restrictions.
Included complex therapy:
For the treatment of severe toxic forms of bacterial and viral infections;
For the treatment of postoperative complications accompanied by septicemia.
As replacement therapy:
With primary immunodeficiency (congenital agammaglobulinemia and hypogammaglobulinemia);
For multiple myeloma with severe secondary hypogammaglobulinemia and recurrent bacterial infections;
In chronic lymphocytic leukemia with a severe form of secondary hypogammaglobulinemia and recurrent bacterial infections when prophylactic therapy is ineffective antibacterial therapy;
At congenital HIV infection with recurrent infections in children.
Contraindications
Hypersensitivity to human immunoglobulin, especially in rare cases of deficiency of immunoglobulin class A (IgA) in the blood and the presence of antibodies against IgA;
Hypersensitivity to the components of the drug;
A history of allergic reactions to blood products. In cases of severe sepsis, the only contraindication for administration is a history of anaphylactic shock to blood products.
With caution:
For persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, it is recommended to prescribe immunoglobulin on the day of immunoglobulin administration and for the next 8 days. antihistamines. During the period of exacerbation of the allergic process, the drug is administered according to the conclusion of an allergist for health reasons.
For persons suffering from diseases in the genesis of which immunopathological mechanisms are leading (collagenosis, immune blood diseases, nephritis), the drug is prescribed after consultation with an appropriate specialist.
There is a suspected relationship between the administration of intravenous immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis.
Use with caution in the following risk groups:
In persons over 65 years of age;
For hypertension;
For diabetes mellitus;
With vascular diseases or a history of thrombosis;
For hereditary or acquired thrombophilic disorders;
In patients who have been immobile for a long time;
In patients with severe hypovolemia;
In patients with chronic diseases, in which blood viscosity is increased;
In patients with impaired renal function;
With a reduced volume of circulating blood;
At overweight bodies;
While taking medications that have a nephrotoxic effect. In patients at risk of developing acute renal failure or thromboembolism, the drug should be administered at the lowest possible rate and dose.
Pregnancy and lactation:
Safety of use of this medical product during pregnancy and breastfeeding has not been studied in controlled clinical trials. However, long-term clinical experience the use of immunoglobulins for intravenous administration during pregnancy shows that one should not expect any harmful influence during pregnancy, neither in relation to the mother, nor in relation to the fetus or newborn.
Immunoglobulins are excreted in mother's milk and can facilitate the transfer of protective antibodies from mother to newborn. Use during breastfeeding is permitted on the recommendation of the attending physician.
Drug interactions
The drug can be used in complex therapy of the disease in combination with other drugs. In this case, mixing the drug with other drugs is not allowed; for administration it should always be used separate system for infusion.
May reduce the effectiveness of active immunization: live vaccines (against measles, mumps, rubella, chickenpox) are administered no earlier than 3 months later. after administration of immunoglobulin.
If vaccinated against measles within 1 year after administration of immunoglobulin, the effectiveness of the vaccine may decrease. In this regard, it is recommended to monitor antibody levels in patients vaccinated against measles.
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Dosage
The drug is administered intravenously.For children, a single dose of the drug is 3-4 ml/kg body weight, but not more than 25 ml. Immediately before administration, the drug is diluted with 0.9% sodium chloride solution or 5% glucose solution at the rate of 1 part of the drug and 4 parts of the diluting solution. The diluted drug cannot be stored. Diluted immunoglobulin is administered intravenously at a rate of 8-10 drops per minute (faster administration may cause the development of a collaptoid reaction). Infusions are carried out daily for 3-5 days.
For adults, a single dose of the drug is 25-50 ml. Immunoglobulin (without additional dilution) is administered intravenously at a rate of 30-40 drops per minute (faster administration may cause the development of a collaptoid reaction). The course of treatment consists of 3-10 transfusions, carried out every 24-72 hours (depending on the severity of the disease).
Replacement therapy for primary immunodeficiency: a single dose is 8-16 ml/kg body weight once. The administration is repeated every 2-4 weeks at a dose of 4-16 ml/kg body weight to maintain the IgG titer in plasma at a level of 4-6 g/l. Plasma IgG levels should be monitored to determine the optimal dose and interval between doses.
Replacement therapy for multiple myeloma with severe secondary hypogammaglobulinemia and recurrent bacterial infections: for chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent bacterial infections when preventive antibiotic therapy is ineffective; for congenital HIV infection with recurrent infections in children: the dose is 4-8 ml/kg body weight. The administration is repeated after 3-4 weeks to maintain the plasma IgG concentration at a level of 4-6 g/l. Plasma IgG levels should be monitored to determine the optimal dose and interval between doses.
The drug is used only in a hospital setting, subject to all aseptic rules. The drug is not suitable for use in bottles (flasks) with damaged integrity, labeling, as well as changes in color, transparency, expired, or improperly stored. Before administration, bottles (vials) are kept at a temperature of (20±2) °C for at least 2 hours.
Overdose
An overdose of the drug in patients at risk, especially the elderly, as well as in patients with impaired renal function, can lead to hypervolemia and increased blood viscosity.Name:
Immunoglobulin (Immunoglobulinum)
Pharmacological
action:
The drug is immunomodulatory and immunostimulating agent. Contains large number 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.
With intravenous administration the bioavailability of the drug is 100%. There is a gradual redistribution between the extravascular space and human plasma active substance drug. 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;
- 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.
Directions for use:
Immunoglobulin is administered intravenously by drip And intramuscularly. The dosage is prescribed strictly individually, taking into account the type and severity of the disease, the individual tolerance of the patient and the state of his immune system.
Side effects:
If, when using the drug, all recommendations for administration, dosage and precautions are followed, then the presence of serious side effects noted very rarely. 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, high temperature 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);
cardiovascular system (cyanosis, tachycardia, chest pain, flushing of the face);
- central nervous system
(drowsiness, weakness, rarely symptoms of aseptic meningitis - nausea, vomiting, headache, photosensitivity, impaired consciousness, stiff neck);
- 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.
In very rare cases collapse, loss of consciousness and severe hypertension were observed. In these severe cases, discontinuation of the drug is necessary. It is also possible to administer antihistamines, adrenaline and plasma replacement solutions.
Contraindications:
The drug should not be used 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 for 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 immunopathological mechanisms are the main ones (nephritis, collagenosis, immune blood diseases), then the drug should be prescribed with caution after the conclusion of a specialist.
Interaction with
other medicinal
by other means:
The drug is pharmaceutically incompatible with other drugs. It should not be mixed with other drugs; a separate dropper should always be used for infusion. When using Immunoglobulin simultaneously with active immunization agents for such viral diseases, such as rubella, chickenpox, measles, and mumps, the effectiveness of treatment may be reduced. If parenteral use of live viral vaccines is necessary, they can be used at least 1 month after taking Immunoglobulin. A more desirable waiting period is 3 months. If a large dose of Immunoglobulin is administered, its effect can last for a year. This drug should also not be used in combination with calcium gluconate in children. infancy. There are suspicions that this will lead to negative phenomena.
